Evidence Report/Technology Assessment 

Number 109 

Sexuality and Reproductive Health Following Spinal 

Cord Injury

Prepared for: 

Agency for Healthcare Research and Quality 

U.S. Department of Health and Human Services 

540 Gaither Road 

Rockville, MD 20850 

www.ahrq.gov 

Contract No. 290-02-0021 

Prepared by: 

University of Ottawa Evidence-based Practice Center at 

the University of Ottawa, Ottawa Canada 

David Moher, Ph.D. 

Howard M Schachter, Ph.D. 

Co-directors

Investigators

Dan DeForge, M.D., F.R.C.P.C. 

Jeff Blackmer, M.D., M.H.Sc., F.R.C.P.C. 

David Moher, Ph.D. 

Chantelle Garritty, B.A., D.C.S. 

Fatemeh Yazdi, M.Sc. 

Valerie Cronin, R.N., S.C.M., B.A., M.A. 

Nick Barrowman, Ph.D. 

Vasil Mamaladze, M.D., Ph.D. 

Li Zhang, M.L.I.S. 

Margaret Sampson, M.L.I.S. 

AHRQ Publication No. 05-E003-2 

November 2004 
 

This report may be used, in whole or in part, as the basis for development of clinical practice 

guidelines and other quality enhancement tools, or a basis for reimbursement and coverage 

policies. AHRQ or U.S. Department of Health and Human Services endorsement of such 

derivative products may not be stated or implied. 

AHRQ is the lead Federal agency charged with supporting research designed to improve the 

quality of health care, reduce its cost, address patient safety and medical errors, and broaden access 

to essential services. AHRQ sponsors and conducts research that provides evidence-based 

information on health care outcomes; quality; and cost, use, and access. The information helps 

health care decisionmakers—patients and clinicians, health system leaders, and policymakers—

make more informed decisions and improve the quality of health care services. 
This document is in the public domain and may be used and reprinted without permission except 

those copyrighted materials noted for which further reproduction is prohibited without the 

specific permission of copyright holders. 

Suggested Citation: 

DeForge D, Blackmer J, Moher D, Garritty C, Cronin V, Yazdi F, Barrowman N, Mamaladze V, 

Zhang L, Sampson M. Sexuality and Reproductive Health Following Spinal Cord Injury. 

Evidence Report/Technology Assessment No. 109 (Prepared by the University of Ottawa 

Evidence-based Practice Center under Contract No. 290-02-0021). AHRQ Publication No. 05-

E003-2. Rockville, MD: Agency for Healthcare Research and Quality. November 2004.

ii 
Preface 

The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-Based 

Practice Centers (EPCs), sponsors the development of evidence reports and technology 

assessments to assist public- and private-sector organizations in their efforts to improve the 

quality of healthcare in the United States. The reports and assessments provide organizations 

with comprehensive, science-based information on common, costly medical conditions and new 

healthcare technologies. The EPCs systematically review the relevant scientific literature on 

topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to 

developing their reports and assessments. 

To bring the broadest range of experts into the development of evidence reports and health 

technology assessments, AHRQ encourages the EPCs to form partnerships and enter into 

collaborations with other medical and research organizations. The EPCs work with these partner 

organizations to ensure that the evidence reports and technology assessments they produce will 

become building blocks for healthcare quality improvement projects throughout the Nation. The 

reports undergo peer review prior to their release. 

AHRQ expects that the EPC evidence reports and technology assessments will inform 

individual health plans, providers, and purchasers as well as the healthcare system as a whole by 

providing important information to help improve healthcare quality. 

We welcome comments on this evidence report. They may be sent by mail to the Task Order 

Officer named below at: Agency for Healthcare Research and Quality, 540 Gaither Road, 

Rockville, MD 20850, or by e-mail to epc@ahrq.gov. 

Carolyn M. Clancy, M.D. 

Director

Agency for Healthcare Research and Quality 

Jean Slutsky, P.A., M.S.P.H 

Director, Center for Outcomes and Evidence 

Agency for Healthcare Research and Quality 

Kenneth S. Fink, M.D., M.G.A., M.P.H. 

Director, EPC Program

Agency for Healthcare Research and Quality 

Ernestine W. Murray, B.S.N., R.N., M.A.S. 

EPC Program Task Order Officer 

Agency for Healthcare Research and Quality 

The authors of this report are responsible for its content. Statements in the report should not be 

construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. 

Department of Health and Human Services of a particular drug, device, test, treatment, or other 

clinical service. 

iii 
Acknowledgments 

The authors would like to thank several individuals for their support of the present project: Nick 

Barrowman, who helped with the statistical analysis, Margaret Sampson, who helped with 

conducting the literature search, and Drs. Isabella Steffensen and Christine Murray for their 

assistance in the writing and editing of this report. 

iv 
Structured Abstract 

Context: Spinal cord injury (SCI) is most often the result of a trauma to the spinal cord, but can 

also be associated with congenital or degenerative disease. In the United States alone, there are 

currently approximately a quarter million people with SCI. Sexual dysfunction in people with 

SCI may have both physiological and psychological (e.g., body image, self esteem) elements that 

can be distressing regardless of the persons’ gender, age or culture. Although some men with 

SCI are unable to have erections, many still maintain the ability to have some erectile function, 

albeit of insufficient quality and duration for intercourse. Many techniques currently exist to 

remediate erectile dysfunction in men with SCI. These include devices such as the vacuum

erection device as well as the injection of vasoactive drugs into the penis. A recent innovation to 

improve erectile function in men with SCI has been the approval of the drugs such as sildenafil 

(Viagra®). Remediation of sexual dysfunction in women with SCI has until recently been 

largely ignored in the literature. 

Objectives: This report focuses on two questions: (1) issues related to fertility, pregnancy rates, 

and live births in persons with SCI, and (2) issues related to male impotence post-SCI. 

Reproductive health: What is the current fertility rate for men and women after SCI? 

• Are fertility rates changed by freezing a new patient’s sperm?

• Are there better fertility rates using electroejaculation or vibration? Does order of

method influence outcome?

• To improve fertility rates, when should invasive techniques such as testicular biopsy or 

aspiration or ICSI be pursued?

• Are there pregnancy complications and prospective obstetric management issues for SCI 

females?

Male sexuality: How has the availability of Viagra® and other remediation affected sexual 

function, frequency of activity, and adjustment after SCI?

• Is Viagra® really more benign than intracavernous injections? 

• How does the morbidity of prostaglandin injections compare to the older (less expensive) 

papaverine? 

• What is the morbidity of vacuum tumescence devices?

• What indications, if any, remain for implantable penile prosthetic devices?

Data Sources: The databases searched were Medline (1966–June Week 1 2003), Premedline 

(June 13 2003) and CINAHL (1975–June Week 1 2003), the Cochrane Central Register of 

Controlled Trials, (1st Quarter, 2003), SocioFile (1974–June 2003) and PsycInfo (1887–June 

v 
Week 1 2003). The annual proceedings (1997–2002, inclusive) of several groups were searched: 

the American Urological Association, International Society of Sexual and Impotence Research, 

International Society for the Study of Woman's Sexual Health, American Paraplegia Society, 

American Association of Spinal Cord Injury Nurses, American Association of Spinal Cord 

Injury Psychologists and Social Workers, American Association of Sex Educators, Counselors 

and Therapists, American Spinal Injury Association, American Academy of Physical Medicine 

and Rehabilitation, and American Congress of Rehabilitation Medicine. Several manufacturers 

were also approached for potential data including: Eli Lilly Canada Inc., Bayer Group, Unimed 

Pharmaceuticals Inc., Mentor Corporation, Vivus Inc., Timm Medical Technologies, ScheringPlough Corporation, Pfizer, Sabex 2002 Inc., and Novartis Pharmaceuticals. 

Study Selection: All results of searches for evidence were screened against the eligibility 

criteria. As an extension of the phase I feasibility study, two reviewers were employed at the 

relevance assessment phase of the evidence review. Two levels of screening for relevance were 

used, with the first level directed at bibliographic records during phase I, the feasibility study 

(i.e., title, authors, key words, abstract), and the second level focused on those “full report” 

articles retrieved based on the results of the first level of screening. Following a calibration 

exercise, two reviewers independently broad screened the title, abstract, and key words from

each bibliographic record for relevance by liberally applying the eligibility criteria. The record 

was retained if it appeared to contain pertinent study information. If the reviewers did not agree 

in finding at least one unequivocal reason for excluding a report, it was entered into the next 

phase of the review. The screening process also identified which of the two questions the record 

addressed. Excluded studies were noted, as was the reason for their ineligibility.

Data Extraction: Data abstracted included the characteristics of the report (e.g., publication 

status, language of publication, year of publication), study (e.g., sample size; research design; 

number of arms), population (e.g., age; percent males; diagnosis description), 

intervention/exposure (e.g., Viagra® for sexual function; testicular biopsy for fertility rates) and 

participant dropouts and withdrawals. A qualitative synthesis was completed for all studies 

included in the evidence report. This was performed on a question-specific basis, with studies 

grouped according to research design. Each synthesis includes a narrative summary of the key 

defining features of the study report, if stated, population, intervention/exposure, outcomes, 

study quality, applicability, and individual study results. Meta-analytical techniques for single 

proportions were used, when appropriate. 

Data Synthesis: A total of 2,420 bibliographic records were retrieved. After duplicate records 

were removed, 2,082 unique items remained. An additional 46 potentially relevant studies were 

identified through conference abstracts or were nominated by manufacturers. A total of 2,128 

reports were evaluated against the eligibility criteria. In total, 122 reports were included in the 

systematic review: 66 of the reports examined fertility and 56 reports examined sexual 

dysfunction in individuals with SCI. 

The 122 studies included 6,668 individuals, ranging in age from 16 years to 81 years, of 

which 78% of the studies reported 100% male participation, with 6% reporting all female 

participation. The complete spectrum of SCI severity was included across the studies. The 

majority of studies included in this review used a non-comparative study design (61%) to address 

the question under consideration. The quality of reporting of the 122 studies included was less 

vi 
than optimal. For example, of the 75 non-comparative studies, none of them reported on all the 

quality items we used to evaluate their reports. 

No studies were found that investigated fertility in females after SCI. For male fertility, 

ejaculation interventions in the last decade resulted in an overall ejaculation response rate of 95% 

(random effects pooled estimate: 0.95 [95% C.I. 0.91, 0.99]). Data from 13 studies over the past 

10 years documenting pregnancy rates indicate rates of 51% (random effects pooled estimate: 

0.51 [95% C.I. 0.42, 0.60]). Data from the 11 studies over the past 10 years documenting livebirth rates indicate live birth rates of 41% (random effects pooled estimate: 0.41 [95% C.I. 0.33, 

0.49]). 

We found eight reports that examined the phenomena of sexual arousal in response to 

physical and cognitive stimulation in women. These papers describe the separate roles of 

physical reflex and cognitive pathways in the sexual response in SCI females, but did not test 

treatment methods for dysfunction. Several interventions (i.e., behavioral, topical agents, 

intraurethral Alprosatadil, intracavernous injections, vacuum tumescence devices, penile 

implants, sacral stimulators, and pharmacological) have been used to evaluate male sexual 

dysfunction. We identified one study that demonstrated improvement in penile rigidity in 10 

SCI males before and after biofeedback, followed by home perineal muscle training exercises. 

Three non-comparative case-series studies and one controlled trial examined the use of topical 

vasodilators for erectile dysfunction in 53 SCI males, all demonstrating low efficacy or 

tolerability. Two case-series studies involving 30 SCI males describe the use of intraurethral 

Alproatadil for SCI male erectile dysfunction with high tolerability but low efficacy. Eight noncomparative case series involving 263 SCI males using intracavernous penile injections of 

vasodilating agents described poolable efficacy data along with side-effect profiles. The 

injection technique was highly efficacious, with a 90% satisfactory erection response rate 

(random effects pooled estimate: 0.90 [95% C.I. 0.83, 0.97]) and was well tolerated when 

appropriate precautions were taken. Only two case series involving 50 males examined vacuum

tumescence devices. Although well tolerated, only a select group chose to use these devices; 

those that did choose to use them reported a high level of satisfaction. Nine studies, of which 

two were RCTs and seven were case-series studies, evaluated Viagra® in 627 SCI males. 

Although less efficacious than injections, Viagra® resulted in a 79% successful erectile function 

(random effects pooled estimate: 0.79 [95% C.I. 0.68, 0.90]). In addition, Viagra® was well 

tolerated and often preferred by SCI males. Finally, five case-series studies examined the 

efficacy and morbidity of penile implants in 363 male SCI subjects, and demonstrated a high 

satisfaction rate but also had a much higher complication rate than the other treatment options. 

Conclusions: Apart from case reports and opinion pieces, there is a paucity of literature 

regarding fertility and pregnancy in SCI females. There is a relatively large body of evidence 

regarding males with SCI. Using vibration and electroejaculation, most SCI males can produce 

semen for fertility purposes. The level of invasiveness is likely more of a factor than either the 

choice or the order of these two interventions. Vibration should be tried at least on all upper 

motor neuron injuries first, with electroejaculation reserved for those individuals in whom

vibration failed and those with lower motor neuron injuries. Advanced fertility techniques can 

increase pregnancy rates for an SCI male to above 50% per couple. Freezing of sperm, unless 

done in the first one or two weeks after SCI, and even if done earlier, is unlikely to make a 

significant improvement in SCI fertility rates and therefore is not widely practiced. Penile 

injection, Viagra®, and vacuum devices can help most erectile function problems in SCI males, 

vii 
making the need for penile implants less common. These interventions positively affect sexual 

activity at least in the short-term. Long-term sexual adjustment has not been examined. 

viii 
Contents 

Evidence Report 

Chapter 1. Introduction ................................................................................................................... 3 

Overview..................................................................................................................................... 3 

Phase 1 Feasibility Study............................................................................................................ 4 

Summary of Findings—Existing Evidence Base.................................................................... 5 

Conclusions............................................................................................................................. 6 

Chapter 2. Methods......................................................................................................................... 7 

Overview..................................................................................................................................... 7 

Key Questions Addressed in This Report................................................................................... 7 

Study Identification..................................................................................................................... 8 

Search Strategy ....................................................................................................................... 8 

Eligibility Criteria ................................................................................................................... 9 

Study Selection Process.......................................................................................................... 9 

Data Abstraction ....................................................................................................................... 10 

Summarizing the Evidence ....................................................................................................... 10 

Overview............................................................................................................................... 10 

Study Quality ........................................................................................................................ 11 

Qualitative Data Synthesis.................................................................................................... 12 

Quantitative Data Synthesis.................................................................................................. 12 

Chapter 3. Results......................................................................................................................... 13 

Results of Literature Search...................................................................................................... 13 

Report and Study Design Characteristics of Included Studies ................................................. 13 

Fertility in Females After SCI............................................................................................... 14 

Fertility in Males After SCI.................................................................................................. 14 

Interventions for Female Sexual Dysfunction ...................................................................... 15 

Male Sexual Dysfunction...................................................................................................... 15 

General Results......................................................................................................................... 15 

Question 1. What is the Current Fertility Rate for Men and Women After SCI?..................... 16 

Fertility in Females After SCI............................................................................................... 16 

Fertility in Males After SCI.................................................................................................. 16 

Are Fertility Rates Changed After Freezing a New Patient's Sperm? .................................. 23 

Are There Better Fertility Rates Using Electroejaculation or Vibration? Does Order of 

Method Influence Outcome?................................................................................................. 23 

To Improve Fertility Rates, When Should Invasive Techniques Such as Testicular Biopsy or 

Intracytoplasmic Sperm Injection be Used? ......................................................................... 25 

Are There Pregnancy Complications and Prospective Obstetric Management Issues for SCI 

Females? ............................................................................................................................... 26 

Question 2. How has the Availability of Viagra® and Other Remediation Affected Sexual 

Dysfunction and Adjustment After SCI?.................................................................................. 26 

Interventions for Female Sexual Dysfunction ...................................................................... 26 

Male Sexual Dysfunction...................................................................................................... 28 

ix 
Is Viagra Really More Benign Than Intracavernous Injections?.......................................... 33 

How Does the Morbidity of Prostaglandin Injections Compare With the Older, Less 

Expensive Papaverine or Phentolamine................................................................................ 35 

What is the Morbidity of Vacuum Tumescence Devices?.................................................... 36 

What Indications, if Any, Remain for Implantable Penile Prosthetic Devices?................... 36 

Chapter 4. Discussion ................................................................................................................... 39 

Limitations................................................................................................................................ 39 

Fertility in Females After SCI................................................................................................... 39 

Fertility in Males After SCI...................................................................................................... 40 

Sperm Quality in Males With SCI........................................................................................ 41 

Sexual Dysfunction in Females With SCI ................................................................................ 42 

Male Sexual Dysfunction.......................................................................................................... 42 

Research and Clinical Implications .......................................................................................... 42 

Conclusions............................................................................................................................... 43 

References and Included Studies.................................................................................................. 47 

List of Excluded Studies............................................................................................................... 55 

Fertility.................................................................................................................................. 55 

Sexual Dysfunction............................................................................................................... 62 

Tables 

Table 1: Key Issues on the Topic of Sexuality and Reproductive Health in Persons With 

 SCI as Identified by the Consortium for Spinal Cord Medicine....................................4 

Table 2: Inclusion Criteria ...........................................................................................................9 

Figures 

Figure 1: Meta-Analysis—Ejaculation .....................................................................................18 

Figure 2: Meta-Analysis—Pregnancy.......................................................................................21 

Figure 3: Meta-Analysis—Live Birth.......................................................................................22

Figure 4: Meta-Analysis—Intracavernous Injections...............................................................30 

Figure 5: Meta-Analysis—Viagra® .........................................................................................33 

Summary Tables 

Table 1: Success Rates of Various Techniques Used to Obtain Semen in Men With SCI.......19 

Table 2: Study Examining the Impact of Freezing Sperm........................................................23 

Table 3: Success Rates and Complications Observed With Electroejaculation and/or 

 Vibration .....................................................................................................................24 

x 
Table 4: Pregnancy and Live Birth Rates for Studies That Used AF Techniques 

 Compared With Those That Did Not..........................................................................26 

Table 5: Studies Examining Various Interventions for Female Sexual Dysfunction ...............27 

Table 6: Evidence for the Use of Vasoactive Agents to Stimulate Erection in Men

 With SCI .....................................................................................................................28 

Table 7: Evidence for the Use of Intraurethral Alprostadil to Stimulate Erection in 

 Men With SCI.............................................................................................................29 

Table 8: Case-Series Evidence for the Use of Penile Implants for Erectile Dysfunction 

 in Men With SCI.........................................................................................................31 

Table 9: RCT Evidence for the Use of Viagra® for Sexual Dysfunction in Men With SCI.... 32 

Table 10: Side Effects Associated With the Use of Intracavernous Injection or Viagra® 

 for Sexual Dysfunction in Men with SCI ...................................................................34 

Table 11: Side Effects Associated With Intracavernous Injections............................................36 

Appendixes 

Appendix A: Search Strategy................................................................................................A-1 

Appendix B: Letter to Industry Representative ....................................................................B-1 

Appendix C: Modified QUOROM Flow Chart ....................................................................C-1 

Appendix D: Data Assessment and Data Abstraction Forms............................................... D-1 

Appendix E: Evidence Tables and Listing of Included Studies ...........................................E-1 

Appendix F: Additional Acknowledgements........................................................................ F-1 

Appendixes and Evidence Tables are provided electronically at 

http://www.ahrq.goc/clinic/epcindex.htm 

xi 
Introduction

Spinal cord injury (SCI) is most often the

result of a trauma to the spinal cord, but can also

be associated with congenital or degenerative

disease. In the United States alone currently there

are approximately a quarter million people with

SCI. Every year, approximately 10,000 people in

the United States survive an acute traumatic

injury to the spinal cord. The majority of these

people are male and under the age of 25.1 In

addition to paralysis, persons with SCI will likely

experience problems with bladder and bowel

control, as well as alterations in sexual

functioning.1,2-4 The impact of a SCI on sexual

functioning depends on the degree of the injury

and its location on the spinal cord.5,6 Sexual

dysfunction in persons with SCI may have both

physiologic and psychological (e.g., body image,

self esteem) elements that can be distressing

regardless of the person’s gender, age, or culture.

Both men and women report a decreased

desire for sexual activity following their injury.7,8

Frequency of sexual activity is also known to

decrease after injury in both men and women.7,8

In men with SCI, factors affecting sexuality

typically include erectile and ejaculatory

dysfunction.9-11 Factors affecting women with SCI

may include difficulties having comfortable

intercourse, and the ability to reach or feel

orgasm.5,12,13

Although some men with SCI are unable to

have erections, many still maintain the ability to

have some erectile function, albeit of insufficient

quality and duration for intercourse.14 Possible

treatments include devices such as the vacuum

erection device as well as the injection of

vasoactive drugs into the penis.15,16 A recent

innovation to improve erectile function in men

with SCI has been the approval of the drugs such

as sildenafil (Viagra®). Infertility is an issue for

men with SCI14,17,18 more than with women. Male

infertility results from the combination of

ejaculatory dysfunction and abnormal sperm

quantity and quality. Techniques to remediate

erectile dysfunction and ejaculation have vastly

improved the fertility potential of men with

SCI.19-23 Stimulation to obtain ejaculate for

insemination of a partner is now routinely

performed. Usually, ejaculate is obtained through

the use of penile vibratory stimulation or

electroejaculation, but other techniques to treat

SCI-related male infertility are myriad.

Health care providers have become increasingly

aware of the importance of sexuality in the

rehabilitation process.22,23 Current approaches to

“best practices” concerning the topic of sexuality

and reproductive health in persons with SCI are

opinion-based, typically generated by clinical

experience with small patient populations in select

hospitals and rehabilitation facilities. The

Consortium for Spinal Cord Medicine (sponsored

by the Paralyzed Veterans of America) has

identified the issue of sexuality and reproductive

health to be a high priority topic for improving

the quality of life for persons with SCI.

Last year, at the request of the Consortium for

Spinal Cord Medicine, the Agency for Healthcare

Research and Quality (AHRQ) commissioned the

University of Ottawa’s Evidence-based Practice

Evidence Report/Technology Assessment

Number 109

Sexuality and Reproductive Health Following Spinal

Cord Injury Summary

Authors: DeForge D, Blackmer J, Moher D, Garritty C, Cronin V, Yazdi F, 

Barrowman N, Mamaladze V, Zhang L, Sampson M

Agency for Healthcare Research and Quality

Advancing Excellence in Health Care • www.ahrq.gov

Agency for Healthcare Research and Quality Evidence-Based

Practice
2

Center (UO-EPC) to conduct a feasibility study to determine if

there is sufficient credible literature to support a comprehensive

systematic review on the topic of “Sexuality and Reproductive

Health Following SCI.” In this feasibility report a reasonably

large body of evidence was identified examining different

aspects of sexuality and reproductive health following SCI. In

general, these studies are of a lower level of evidence and open

to several sources of bias. Therefore, AHRQ requested a

comprehensive evidence report that incorporates and builds on

findings from the UO-EPC phase I feasibility study. 

Key Questions

As a result of findings from the phase I feasibility study, this

report focuses on two questions and their sub-questions.

Question 1 focuses on issues related to fertility, pregnancy rates,

and live births in persons with SCI. Question 2 focuses on

issues related to male impotence post SCI.

1. Reproductive health: What is the current fertility rate for

men and women after SCI? 

• Are fertility rates changed by freezing a new patient’s

sperm?

• Are there better fertility rates using electroejaculation

or vibration? Does order of method influence

outcome?

• To improve fertility rates, when should invasive

techniques such as testicular biopsy or aspiration or

intracytoplasmic sperm injection (ICSI) be pursued?

• Are there pregnancy complications and prospective

obstetric management issues for SCI females?

2. Male sexuality: How has the availability of Viagra® and

other remediation affected sexual function, frequency of

activity, and adjustment after SCI?

• Is Viagra® really more benign than intracavernous

injections?

• How does the morbidity of prostaglandin injections

compare to the older (less expensive) papaverine?

• What is the morbidity of vacuum tumescence devices?

• What indications, if any, remain for implantable

penile prosthetic devices?

Methods

A Technical Expert Panel (TEP) consisting of six members

was convened to provide advisory support to the project,

including refining the questions and highlighting key variables

requiring consideration in the evidence synthesis.

Study Identification

Building on a preliminary search strategy conducted by UOEPC in the feasibility task order, a comprehensive updated

search for citations was conducted using six databases

(MEDLINE®, PreMEDLINE®, CINAHL®, Cochrane

Central Register of Controlled Trials, SocioFile, and

PsycINFO). Following the suggestions of the TEP, additional

published literature was sought through searches of relevant

associations’ proceedings for the years 1997-2002. In addition,

industry was contacted for ongoing and/or unpublished data. A

final set of 2,128 unique references was identified and posted to

the UO-EPC’s Internet-based software system for review. 

Eligibility Criteria 

Studies were considered relevant if they described both male

and/or female (adult or adolescent) populations with SCI,

involved any type of study design; published or unpublished,

and reported in English. Studies were also eligible for inclusion

if each met predetermined criteria. In reproductive health,

design criteria consisted of whether the study discussed a

fertility intervention; included a pre and post intervention for

fertility rates; contained an original report of a measure of

fertility rates in males, females, or both; or whether it reported

an original intervention trial after SCI. Eligible interventions

included physical, surgical, laboratory techniques, or

prescription medications. Eligible fertility outcomes included

pregnancies, live birth rates, sperm motility, successful sperm

harvesting, ejaculations, sperm count, percent viable sperm,

hormonal, ovulation rates, cycle function, other measures of

sperm morphology, and volume of ejaculation. 

In male sexuality, design criteria consisted of whether the

study reported an original intervention trial or series with a pre

and post measure for sexual dysfunction after SCI, contained

an original report of a measure of sexual dysfunction, or

whether the article discussed an intervention for sexual

dysfunction. Eligible interventions included

cognitive/behavioral, prescription medications, and surgical or

hormonal interventions. Eligible outcomes included

psychological outcomes (e.g., validated sexual function

questionnaire for males and/or females, structured interviews

with qualitative analysis, educational component, global

efficiency, or patient logs), and/or physiologic outcomes (e.g.,

penile and/or clitoral engorgement, endocrine, ultrasound

testing of testicular size).

As an extension of the phase I feasibility study, two reviewers

were employed at the relevance assessment phase of the

evidence review. Two levels of screening for relevance were used,

with the first level directed at bibliographic records during
phase I, the feasibility study (i.e., title, authors, key words,

abstract), and the second level focused on those “full report”

articles retrieved based on the results of the first level of

screening. Screenings for relevance, assessments of study quality,

and data abstraction were completed using the UO-EPC’s

review management Internet-based software, which resides on a

secure Web site. 

Calibration exercises preceded each step of the screening

process. Excluded studies were noted as to the reason for their

ineligibility using a modified QUOROM format.24 Reports

were not masked given the equivocal evidence regarding the

benefits of this practice.25,26 Disagreements were resolved by

forced consensus and, if necessary, by a third party. 

Data Abstraction 

Following a calibration exercise, two reviewers independently

abstracted the contents of each included study using an

electronic data abstraction form developed especially for this

review. Once reviewers completed their work, all work was

checked by their counterparts. Data abstracted included the

characteristics of the following: report (e.g., publication status,

language of publication, year of publication); study (e.g.,

sample size, research design, number of arms); population (e.g.,

age, percent males, diagnosis description);

intervention/exposure (e.g., Viagra® for sexual function,

testicular biopsy for fertility rates); and withdrawals and

dropouts.

Study Quality

In this report, study quality was assessed through

examination of each individual report rated independently by

two assessors. Quality was defined as the confidence that the

study’s design, conduct, analysis, and presentation has

minimized or avoided biases in any comparisons.27 Several

approaches exist to assess quality: components, checklists, and

scales. Therefore, a combination of methods was used in an

effort to ascertain a measure of reported quality across different

study designs. 

For RCTs the Jadad scale was used. This is a validated scale

consisting of three items that assesses the methods used to

generate random assignments, double blinding, and a

description of dropouts and withdrawals by intervention

group.28 The scoring ranges from one to five, with higher

scoring indicating higher quality. In addition, allocation

concealment (i.e., keeping the randomization blind until the

point of allocating participants to an intervention group) was

assessed as adequate, inadequate, or unclear.29 An a priori

threshold scheme was used for sensitivity analysis: a Jadad total

score of < 2 indicates low quality with scores > 2 indicating

higher quality. 

Cohort and case-control study reports were assessed using

the Newcastle-Ottawa scale (NOS).30 The NOS is an ongoing

collaboration between the Universities of Newcastle, Australia,

and Ottawa, Canada. It was developed to assess the quality of

nonrandomized studies with its design, content, and ease-of-use

directed to the task of incorporating the quality assessments in

the interpretation of meta-analytic results. 

Qualitative Data Synthesis

A qualitative synthesis was completed for all studies included

in the evidence report. A description is provided of the progress

of each citation through the review process, and includes

information pertaining to each report, such as their sample size.

The qualitative synthesis was performed on a question-specific

basis, with studies grouped according to research design (e.g.,

RCTs, observational studies). Each synthesis includes a

narrative summary of the key defining features of the study

report, if stated, (e.g., a priori description of inclusion/exclusion

criteria), population (e.g., diagnosis-related),

intervention/exposure (e.g., use of Viagra®), outcomes, study

quality, applicability, and individual study results. A brief studyby-study overview typically precedes a qualitative synthesis.

Quantitative Data Synthesis

For several of the questions investigated in this evidence

report, quantitative data synthesis was deemed appropriate.

However, most of the studies were non-comparative case series

and outcomes were in the form of single proportions (e.g.,

proportion of couples achieving at least one pregnancy).

Current meta-analytic methodology generally focuses on data

from studies that include a control group, such as randomized

controlled trials. From a meta-analytic perspective, one of the

strengths of studies that include control groups is that even if

there is some degree of heterogeneity in characteristics such as

population or intervention across studies, there may be little

statistical heterogeneity in the contrast between outcomes in

the treatment and control groups across studies. This protection

against heterogeneity is not available in studies without a

control group. Judicious selection of comparable studies for

inclusion in a meta-analysis of single proportions therefore

becomes especially crucial. In the present work, heterogeneity

of single proportions was assessed using Pearson’s chi-square

test. P-values less than 0.10 were taken to indicate statistically

significant heterogeneity. Forest plots were constructed using

Wilson score confidence intervals around individual study

proportions.31 Pooled estimates and their confidence intervals

were obtained using the random effects estimator of Laird and

Mosteller.32

3
4

Results and Discussion

Literature Search

A total of 2,420 bibliographic records were retrieved through

database searches. After duplicate records were removed, 2,082

unique items remained. An additional 46 potentially relevant

studies were identified through conference abstracts or were

nominated by manufacturers. Therefore, a total of 2,128

reports were evaluated against the eligibility criteria and after

the initial screening for relevance, 1,627 records were excluded.

Although the majority of the initial screening was performed in

the phase I feasibility study, the additional studies that were

identified when the search was “rerun” at the beginning of this

study (n = 98, of which 47 were duplicates) were screened

according to phase I criteria. The reasons for exclusion were:

not relevant to SCI (n = 530); not relevant to sexuality or

reproductive health (n = 410); case report or opinion piece (n =

282); no relevant measure reported (n = 271); not relevant to

any of the questions (n = 78); and, report pertaining to

adolescent or child only (n = 6). The remaining 501 reports

were then retrieved and subjected to a more detailed relevance

assessment. Two hundred and forty-five of these reports dealt

with issues relating to fertility and 289 of the reports examined

sexual dysfunction. After further relevance assessment, 180 of

the 246 reports on fertility and 232 of the 289 reports on

sexual dysfunction failed to meet the inclusion criteria of phase

II. In total, 122 reports were deemed relevant for the systematic

review—66 of the reports examined fertility and 56 reports

examined sexual dysfunction in individuals with SCI. 

Study Results

The 122 studies included 6,668 individuals, ranging in age

from 16 years to 81 years, of which 78 percent of the studies

enrolled only men, with 6 percent reporting all female

participation.* As might be expected, the complete spectrum of

SCI severity was included across the studies. Eighty-seven

studies (71 percent) reported on the level of lesion, however,

only 18 (15 percent) reported on American Spinal Injury

Association level. However, final classifications of data on

severity of SCI injuries are complicated in this review due to

inconsistencies in the reporting of severity of injury. The

majority of studies included in this review used a noncomparative study design (61 percent) to address the question

under consideration. For example, a group of males might be

given a specific intervention to improve ejaculation rates.

Typically, the authors did not select a comparator group and

only reported specific outcomes on this group. Few RCTs exist

to evaluate the efficacy of male sexual dysfunction and the

majority of those are duplicate publications, perhaps giving the

impression of being more broadly evaluated than one might

think on first impressions. The quality of reporting of the 122

studies included here is less than optimal. For example, of the

75 non-comparative studies, none of them reported on all the

quality items we used to evaluate their reports. The highest

number of quality criteria met was 16/19 items, and this was

achieved by only one (1 percent) of the 75 studies.33

Question 1. What is the current fertility rate for men and

women after SCI?

Fertility in females after SCI

There were no studies found that investigated this

question. 

Fertility in males after SCI

Ejaculation rates. Different aspects of male infertility have

been studied. Reports in the literature on this topic can be

grouped, and some information pooled. Much of the earlier

work in this area centers on interventions to aid males with SCI

to ejaculate, either during sexual activities with their partners or

in a clinic situation to harvest semen for implantation.

Different authors and clinics have chosen different

methodologies to aid ejaculation in males with SCI. They

include intrathecal or subcutaneous physostigmine with

masturbation, penile vibration techniques with or without

pharmacologic enhancement, or electroejaculation.

Ejaculation rates results from 22 studies that used vibration

and/or electrode stimulation in males with SCI. Overall, these

interventions resulted in an overall ejaculation response rate of

86 percent (random effects pooled estimate: 0.86, 95% C.I.

0.80, 0.93). When data from studies examining vibration

and/or electrode stimulation to provoke ejaculation are pooled,

a large degree of heterogeneity is observed. This observation

reflects the inclusion of early studies that were aimed at

establishing optimal parameters for the technique (e.g.,

vibration amplitude, electricity parameters), as well as the

inclusion of more recent studies which implemented the now

common practice of first starting with vibration and later

including electroejaculation to increase success rates.

Pregnancies and live births. Not all authors chose to present

both pregnancy and live birth data. However, there is no

suggestion in the literature that the spontaneous abortion rate

of a pregnancy conceived from an SCI male exceeds that of the

general population; therefore, we chose to combine both sets of

data. These results represent the number of couples who have

achieved at least one pregnancy or live birth over the number of

couples who tried to conceive. It is very important to note that

some authors reported their fertility rates after very simple

* “Couples” were counted as a single case pertaining to number of

participants enrolled. Fourteen percent of the included studies reported on

the enrollment of couples only or couples together with single-case male

participants
procedures such as vibration or electrode ejaculation, whereas

some studies were performed in clinics that greatly increased

the odds of achieving pregnancy by adding a variety of

advanced fertility techniques. Data from the 17 studies

documenting pregnancy rates were pooled and indicate

pregnancy rates of 51 percent (random effects pooled estimate:

0.51, 95% C.I. 0.42, 0.60). Data from the 13 studies

documenting live-birth rates were pooled and indicate live birth

rates of 40 percent (random effects pooled estimate: 0.40, 95%

C.I. 0.33, 0.48). The heterogeneity of these pooled results is

explained by the addition of advanced fertility techniques that

increase the success rates for these endeavors by up to four

times, compared with insemination alone.

Are fertility rates changed after freezing a new patient’s

sperm?

There is little data to support the practice of freezing the

sperm of SCI males after 16 days post-injury, and that even the

advantages of early freezing (within the first 2 weeks) is

outweighed by the loss of sperm motility during the procedure,

since with modern techniques one is virtually certain of

obtaining fresh sperm from the SCI male when he is ready to

conceive a child in later years.

Are there better fertility rates using electroejaculation or

vibration? Does order of method influence outcome?

We were unable to locate any documents demonstrating a

superior fertility outcome between vibration and

electroejaculation. Therefore, we compared the side-effect

profile of the two procedures to determine risk-benefit. Of the

21 studies identified that reported ejaculation rates with

technique, 10 reported adverse events.34-43 Often, authors

combined procedures, although they did not always separate

the side effects by procedure. However, papers that combined

the procedures demonstrated that the vibration technique is less

likely to be successful for lower motor neuron (areflexic)

injuries than with spastic injuries, and electroejaculation is

more likely than vibration to cause autonomic dysreflexia in

patients with spastic injuries.35,37 Electroejaculation also has the

added side effects of inflammation to the rectal mucosa39 and

stimulation pain34,38,39,44 in incompletely injured patients.

Therefore, most clinics that combine these techniques usually

try vibration first followed by electroejaculation in the areflexic

subjects that tend to not respond to vibration alone.

To improve fertility rates, when should invasive techniques

such as testicular biopsy or intracytoplasmic sperm injection

be used?

Invasive techniques to enhance fertility (advanced fertility

[AF] techniques) such as in vitro fertilization and ICSI have

been used more in recent studies. By grouping the 18 studies

above that reported either pregnancies or live births according

to whether they used or did not use AF techniques, one can

assess how using AF techniques impacts fertility rates. In doing

so, one easily observes that to achieve pregnancy and birth rates

approaching 50 percent or greater SCI couples need to use an

AF technique. Testicular biopsy or vas aspirations should be

reserved for those patients who cannot achieve sperm

harvesting or whose harvested sperm by the above techniques is

of very low quality. ICSI can greatly enhance success in those

individuals whose sperm quality is insufficient for intrauterine

insemination.

Are there pregnancy complications and prospective

obstetric management issues for SCI females?

We did not find any reports that provided the necessary data

for us to project the number and frequency of complications

and other obstetric issues in females with SCI. There are

numerous case reports, however, without the larger sample size

obtained with a case-series study, it is difficult to conduct

further research or inform practice or policy regarding this

important health issue.

Question 2. How has the availability of Viagra® and other

remediation affected sexual dysfunction and adjustment

after SCI?

Interventions for female sexual dysfunction

We found six articles that used a case-control design5,45-49 and

one article that used a RCT design50 to examine the

phenomena of sexual arousal in response to physical and

cognitive stimulation in women with SCI. 

Male sexual dysfunction

Most of the literature discusses male erectile dysfunction

after SCI. Aside from a number of RCTs evaluating Viagra®,

all of the studies that we identified which addressed this topic

were case-series studies. The most common problems faced

when trying to analyze this literature is that many authors

chose different outcome measures. For example, some authors

use a validated erectile grading system such as Schramek’s,

whereas others used their own grading system; some authors

used all or parts of the International Index of Erectile Function

(IIEF) sexual satisfaction rating scale, whereas others designed

their own scales. When authors use either an on/off grading

system or a common question on the IIEF, we have pooled the

data when appropriate. Interventions discussed in this review

include: behavioral interventions, topical medications,

intraurethral alprostadil, intracavernous injections, vacuum

tumescence devices, penile implants, sacral stimulators, and

Viagra® (sildafenil).

5
6

Is Viagra® really more benign than intracavernous

injections?

Intracavernous injections have a significantly higher efficacy

than Viagra® (90 percent versus 79 percent). To compare the

side-effect profile of intracavernous injections with that of

Viagra®, we extracted data from the studies described above

that reported side effects. It can be noted that careful dosage

adjustment is necessary with the papaverine or papaverine/

phentolamine combinations. When used alone, prostaglandin

E1 has few side effects outside of its cost. If subjects are reliable

and if they have little sensation there seems to be few

advantages of Viagra® over intracavernous injections aside from

subject and partner preference. Although other

phosphodiesterase inhibitors have come to market since

sildanefil, no SCI treatment data for these drugs were available

at the time of this review.

How does the morbidity of prostaglandin injections

compare with the older, less expensive papaverine or

phentolamine?

Although similar in efficacy, prostaglandin E1 is less stable at

room temperature and much more expensive than papaverine

or phentolamine. Proponents cite a shorter half-life (less chance

of priapism) and less injection-site pain and scarring as reasons

to use this substance despite its expense. We identified six

noncomparative case-series studies51-56 and one RCT57 that

reported the numbers of side effects. Although the efficacy of

these two treatments is similar, priapism and discomfort are

reported more frequently with papaverine.

What is the morbidity of vacuum tumescence devices?

When used with proper clinic instruction and according to

the specifications of the manufacturers, these devices have a

very low morbidity rate with no irreversible morbidities noted.

Although there are case reports of penile ischemia in the

literature, these case reports serve only as a warning not to leave

the device on too long and cannot help us with ascertaining a

complication rate.

What indications, if any, remain for implantable penile

prosthetic devices?

It is notable that although penile implants result in a high

level of satisfaction for those clients who do not have

complications, the serious complication rate is as high as 10

percent. Furthermore, patients who have an implant removed

are no longer candidates for other treatment options as they are

likely to have damage to the penile tissues that would make

them nonresponsive to intracavernous injections or vacuum

devices. Very few patients will not respond to any of the more

benign techniques. 

Availability of the Full Report

The full evidence report from which this summary was taken

was prepared for the Agency for Healthcare Research and

Quality (AHRQ) by the University of Ottawa Evidence-based

Practice Center, Ottawa, Canada under Contract No. 290-02-

0021. It is expected to be available in December 2004. At that

time, printed copies may be obtained free of charge from the

AHRQ Publications Clearinghouse by calling 800-358-9295.

Requesters should ask for Evidence Report/Technology

Assessment No. 109, Sexuality and Reproductive Health

Following Spinal Cord Injury. In addition, Internet users will be

able to access the report and this summary online through

AHRQ’s Web site at www.ahrq.gov.

Suggested Citation

DeForge D, Blackmer J, Moher D, Garritty C, Cronin V,

Yazdi F, Barrowman N, Mamaladze V, Zhang L, Sampson M.

Sexuality and Reproductive Health Following Spinal Cord

Injury. Summary, Evidence Report/Technology Assessment No.

109. (Prepared by the University of Ottawa Evidence-based

Practice Center under Contract No. 290-02-0021.) AHRQ

Publication No. 05-E003-1. Rockville, MD: Agency for

Healthcare Research and Quality. December 2004.

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25. Moher D, Pham B, Jones A, et al. Does quality of reports of

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27. Moher D, Cook DJ, Jadad AR, et al. Assessing the quality of reports

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30. Wells GA, Shea B, O’Connell D, Peterson J, Welch V, Tugwell P. The

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31. Newcombe RG. Improved confidence intervals for the difference

between binomial proportions based on paired data. Stat Med 1998;

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32. Laird NM, Mosteller F. Some statistical methods for combining

experimental results. Int J Technol Assess Health Care 1990;6(1):5-30.

33. Gans WH, Zaslau S, Wheeler S et al. Efficacy and safety of oral

sildenafil in men with erectile dysfunction and spinal cord injury. J

Spinal Cord Med 2001; 24(1):35-40.

34. Brindley GS. Electroejaculation: its technique, neurological

implications and uses. J Neurol Neurosurg Psychiatry 1981;44(1):9-

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35. Halstead LS, VerVoort S, Seager SW. Rectal probe electrostimulation

in the treatment of anejaculatory spinal cord injured men. Paraplegia

1987;25(2):120-9.

36. Sarkarati M, Rossier AB, Fam BA. Experience in vibratory and

electro-ejaculation techniques in spinal cord injury patients: a

preliminary report. J Urol 1987;138(1):59-62.

37. VerVoort SM, Donovan WH, Dykstra DD, et al. Increased current

delivery and sperm collection using nifedipine during

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Med Rehabil 1988;69(8):595-7.

38. Rawicki HB, Hill S. Semen retrieval in spinal cord injured men.

Paraplegia 1991;29(7):443-6.

39. Lim TC, Mallidis C, Hill ST, et al. A simple technique to prevent

retrograde ejaculation during assisted ejaculation. Paraplegia

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40. Sonksen J, Biering-Sorensen F, Kristensen JK. Ejaculation induced by

penile vibratory stimulation in men with spinal cord injuries. The

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41. Pryor JL, LeRoy SC, Nagel TC, et al. Vibratory stimulation for

treatment of anejaculation in quadriplegic men. Arch Phys Med

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42. Beretta G, Chelo E, Zanollo A. Reproductive aspects in spinal cord

injured males. Paraplegia 1989;27(2):113-8.

43. Heruti RJ, Katz H, Menashe Y, et al. Treatment of male infertility due

to spinal cord injury using rectal probe electroejaculation: the Israeli

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44. Ohl DA, Sonksen J, Menge AC, et al. Electroejaculation versus

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45. Sipski ML, Alexander CJ, Rosen RC. Physiological parameters

associated with psychogenic sexual arousal in women with complete

spinal cord injuries. Arch Phys Med Rehabil 1995;76(9):811-8.

46. Sipski ML, Alexander CJ, Rosen RC. Orgasm in women with spinal

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47. Sipski ML, Rosen RC, Alexander CJ. Physiological parameters

associated with the performance of a distracting task and genital selfstimulation in women with complete spinal cord injuries. Arch Phys

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48. Komisaruk BR, Gerdes CA, Whipple B. ‘Complete’ spinal cord injury

does not block perceptual responses to genital self-stimulation in

women. Arch Neurol 1997;54(12):1513-20.

49. Whipple B. Sexual responses to self-stimulation in women with

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7
50. Sipski ML, Rosen RC, Alexander CJ, et al. Sildenafil effects on

sexual and cardiovascular responses in women with spinal cord

injury. Urology 2000;55(6):812-5.

51. Hirsch IH, Smith RL, Chancellor MB, et al. Use of intracavernous

injection of prostaglandin E1 for neuropathic erectile dysfunction.

Paraplegia 1994;32(10):661-4.

52. Tang SF, Chu NK, Wong MK. Intracavernous injection of

prostaglandin E1 in spinal cord injured patients with erectile

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53. Zaslau S, Nicolis C, Galea G, et al. A simplified pharmacologic

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54. Sidi AA, Cameron JS, Dykstra DD, et al. Vasoactive intracavernous

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55. Kapoor VK, Chahal AS, Jyoti SP, et al. Intracavernous papaverine for

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56. Beretta G, Zanollo A, Fanciullacci F, et al. Intracavernous injection of

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8

www.ahrq.gov

AHRQ Pub. No. 05-E003-1

December 2004

ISSN 1530-440X
Evidence Report

 

 

3 

Note: Appendixes and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.goc/clinic/epcindex.htm 

Chapter 1. Introduction 

Overview 

Spinal cord injury (SCI) is most often the result of a trauma to the spinal cord, but can also be 

associated with congenital or degenerative disease. In the United States alone, there are 

currently approximately a quarter million people with SCI.1

 Every year, there are approximately 

10,000 people in the U.S. who survive an acute traumatic injury to the spinal cord, the majority 

of whom are male and under the age of 25.2

 Persons with SCI experience a myriad of acute and 

long-term physical and psychosocial consequences that impact on their quality of life. In 

addition to paralysis, persons with SCI will likely experience problems with bladder and bowel 

control, as well as alterations in sexual functioning.1,3-5

The impact of a SCI on sexual functioning depends on the degree of the injury and its 

location on the spinal cord.6,7 Sexual dysfunction in persons with SCI may have both 

physiological and psychological (e.g., body image, self esteem) elements that can be distressing 

regardless of the persons’ gender, age or culture. The balance between physiologic and 

psychosocial elements coupled with factors such as gender, age and culture will all influence 

how a person with SCI adjusts to their new sexual identity. 

Both men and women report a decreased desire for sexual activity following their injury.8,9 

Frequency of sexual activity is also known to decrease after injury in both men and women.8,9 In 

men with SCI, factors affecting sexuality typically include erectile and ejaculatory 

dysfunction.10-12 Factors affecting women with SCI may include difficulties having comfortable 

intercourse, and the ability to reach or feel orgasm.6,13,14 Many authors and clinicians include 

issues of infertility, pregnancy and delivery when speaking of broader issues of sexuality and 

disability. 

Although some men with SCI are unable to have erections, many still maintain the ability to 

have some erectile function, albeit of insufficient quality and duration for intercourse.15 Many 

techniques currently exist to remediate erectile dysfunction in men with SCI. These include 

devices such as the vacuum erection device as well as the injection of vasoactive drugs into the 

penis.16,17 A recent innovation to improve erectile function in men with SCI has been the 

approval of the drugs such as sildenafil (Viagra®). 

Remediation of sexual dysfunction in women with SCI has until recently been largely 

unreported. However, it has been suggested that treatment of sexual dysfunction in women 

should focus on improving the ability of women with SCI to become aroused and to achieve 

orgasm.3

 

The ability to become a parent is an important issue for younger people with SCI. For 

women with SCI, their hormonal status generally remains unchanged, except for a temporary 

period of amenorrhea following their injury.18,19 They can usually carry a child safely to term 

and may be able to deliver a child naturally depending on the medical status and physical 
limitations to do with the abdomen, spine or pelvis.19 However, infertility is an issue for men 

with SCI.15,20,21

 Infertility results from the combination of ejaculatory dysfunction and abnormal 

sperm quantity and quality. Techniques to remediate erectile dysfunction and ejaculation have 

vastly improved the fertility potential of men with SCI.22-26 Stimulation to obtain ejaculate for 

insemination of a partner is now routinely performed. Usually, ejaculate is obtained through the 

use of penile vibratory stimulation or electroejaculation, but other techniques to treat SCI-related 

male infertility are myriad. 

Health care providers have become increasingly aware of the importance of sexuality in the 

rehabilitation process.25,26 Current approaches to “best practices” concerning the topic of 

sexuality and reproductive health in persons with SCI are opinion-based, typically generated by 

clinical experience with small patient populations in select hospitals and rehabilitation facilities. 

The Consortium for Spinal Cord Medicine (sponsored by the Paralyzed Veterans of America) 

has identified the issue of sexuality and reproductive health to be a high priority topic for 

improving the quality of life for persons with SCI. 

Phase 1 Feasibility Study 

Last year, at the request of the Consortium for Spinal Cord Medicine, the Agency for 

Healthcare Research and Quality (AHRQ) commissioned the University of Ottawa’s evidencebased practice center to conduct a feasibility study to determine if there is sufficient credible 

literature to support a comprehensive systematic review on the topic of “Sexuality and 

Reproductive Health Following SCI.” 

The Consortium for Spinal Cord Medicine drafted eight specific questions that address the 

key issues on the topic of sexuality and reproductive health in persons with SCI (Table 1). We

developed a search strategy based on these questions to examine the existing evidence base 

regarding the topic of “Sexuality and Reproductive Health Following SCI.” We anticipated that 

there may be specific gaps in the literature, with data absent or scant for some of the questions. 

Table 1. Key issues on the topic of sexuality and reproductive health in persons with SCI as identified by the 

Consortium for Spinal Cord Medicine

1. When do people become sexually active after SCI? 

2. What is the frequency of sexual activity in the years post injury? 

3. What is the current fertility rate for men and women after SCI? 

4. How has the availability of Viagra® and/or other remediation affected sexual function, frequency of activity, and 

adjustment after SCI? 

5. What are the unique issues of sexuality for women after SCI?

6. Are there interventions shown to improve sexual responsiveness in women with SCI? 

7. What is the optimal sequencing of effective procedures when pursuing fertility in the SCI male? 

8. When is the most effective time to present information on sexuality after SCI? 

In addressing the original question regarding the feasibility of a comprehensive systematic 

review of sexuality and fertility in SCI, we conclude that such a review is feasible on the whole, 

but only useful in the specific. That is, some of the questions have enough evidence from which 

a review could generate useful recommendations, however, other topics would not be answerable 

given the current state of the literature. 

4 
Summary of Findings—Existing Evidence Base 

What is the current fertility rate for men and women after SCI? We concluded that there is 

a sufficient body of literature to complete a comprehensive systematic review and meta-analysis 

on issues relating to fertility/pregnancy rates/live births in persons with SCI. Although most of 

these studies only report frequency data and/or percentage of “success,” they report sufficient 

data to provide meaningful information. Along this suggestion we believe there is sufficient 

usable data to permit a systematic review and possibly a meta-analysis for other topics such as 

pregnancy complications and prospective obstetric management. 

How has the availability of Viagra® and/or other remediation affected sexual function, 

frequency of activity, and adjustment after SCI? We concluded that a systematic review and 

meta-analysis could be carried out specifically addressing treatments available for treating 

impotence in males with SCI. The permits of such an undertaking would need to be considered 

in light of the possible duplication of reports we identified. As such, and if not corrected, the 

estimates from such a meta-analysis could lead to biased estimates of the intervention’s 

effectiveness. 

What are the unique issues of sexuality for women after SCI? There is a new and growing 

body of literature addressing sexual issues in females with SCI. Many of these studies are 

relatively well designed qualitative interviews and surveys, often involving significant numbers 

of patients. The literature does address the unique issues of sexuality in women. We did not 

believe that a systematic review addressing this question would provide additional insights to 

clinicians and others. 

Are there interventions shown to improve sexual responsiveness in women with SCI? 

There are as of yet few published trials of interventions to improve sexual responsiveness in 

women after SCI. We did not believe that a systematic review on this topic would provide 

meaningful information.

What is the optimal sequencing of effective procedures when pursuing fertility in the SCI 

male? This question is not well addressed in the current literature, except to say that with 

increasing options available the situation is improving. The literature widely accepts that fertility 

is not substantially altered in women after SCI. Furthermore, in males, fertility rates can only be 

deduced in those who choose to be fertile, and will vary according to the degree of pursuit of 

invasive procedures. However, there is a reasonable body of studies regarding the success rates 

of individual techniques and a systematic review would help guide clinicians in choosing the 

order of techniques to apply based on cost, success and potential side effects.

When do people become sexually active after SCI?, What is the frequency of sexual activity 

in the years post injury?, and When is the most effective time to present information on 

sexuality after SCI? We found almost no useful literature addressing these questions, although 

well structured interviews with rigorous attention to qualitative design could answer all three of 

these questions, i.e., when do patients become active, how active do they become, and when do 

they want information. Unfortunately, the literature regarding these questions is largely based on 

5 
the expression of the clinician, rather than the opinion of the patient. Therefore, we concluded 

that a systematic review would not be useful. 

Conclusions 

In summary, we identified a reasonably large body of evidence examining different aspects 

of sexuality and reproductive health following SCI. In general, these studies are of a lower level 

of evidence and open to several sources of bias. On the basis of this report, AHRQ requested a 

comprehensive evidence report that incorporates and builds on findings from the Ottawa EPC 

Phase I Feasibility Study. 

Obviously, not all sexual health questions could be addressed in a systematic review of the 

literature. There are many other noteworthy questions, including questions on impact of quality 

of life on sexual health, the differences in practice from specialized to general centers, and many 

questions regarding quality of life and women’s sexual health. These questions are not 

addressed in sufficient thoroughness in the literature to warrant a systematic review. Also, 

systematic reviews of qualitative literature likely would not add any new insights to this field of 

practice. This was discussed somewhat in the feasibility study mentioned earlier. The 

Consortium of Spinal Cord Medicine helped focus this review by posing a series of questions for 

a systematic review, based on their clinical experience and on the results of the Phase 1 

Feasibility Study. 

6 
 

Note: Appendixes and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.goc/clinic/epcindex.htm 

7

Chapter 2. Methods 

Overview 

The UO-EPC’s evidence report on sexuality and reproductive health following SCI is based 

on a systematic review to identify, and synthesize the results from studies addressing two key 

questions put forth by the Consortium for Spinal Cord Medicine. Together with content experts, 

UO-EPC staff identified specific issues integral to the review. A Technical Expert Panel (TEP) 

provided expert guidance as to the conduct of the systematic review. Synthesis tables (i.e., 

evidence tables) presenting the key study characteristics and results from each included study 

were developed. Summary tables were derived from the synthesis tables. The methodological 

quality of the included studies was appraised, and individual study results were summarized. 

Key Questions Addressed in This Report 

As a result of findings from the phase I feasibility study, the comprehensive report will focus 

on two questions and their sub-questions. Question 1 focuses on issues related to fertility, 

pregnancy rates, and live births in persons with SCI. Question 2 focuses on issues related to 

male impotence post SCI. 

1. Reproductive health: What is the current fertility rate for men and women after SCI? 

• Are fertility rates changed by freezing a new patient’s sperm? 

• Are there better fertility rates using electroejaculation or vibration? Does order of 

method influence outcome? 

• To improve fertility rates, when should invasive techniques such as testicular biopsy 

or aspiration or ICSI be pursued? 

• Are there pregnancy complications and prospective obstetric management issues for 

SCI females? 

2. Male sexuality: How has the availability of Viagra® and other remediation affected 

sexual function, frequency of activity, and adjustment after SCI? 

• Is Viagra® really more benign than intracavernous injections? 
• How does the morbidity of prostaglandin injections compare to the older (less 

expensive) papaverine?

• What is the morbidity of vacuum tumescence devices?

• What indications, if any, remain for implantable penile prosthetic devices?

Study Identification 

Search Strategy

A search strategy was developed and tested in Medline (Search Strategy 1, Appendix A), and 

modified as necessary for other databases (Search Strategy 2, Appendix A). The strategy was 

based on a preliminary strategy proposed by UO-EPC in a feasibility task order, and was 

modified in consultation with three members of the review team (DD, JB and VC). The strategy 

was designed to be highly sensitive and was not restricted by study design, language of 

publication or publication status. Some of the databases searched were nominated by AHRQ in 

the work assignment, other databases were selected to provide more complete coverage of key 

journals nominated by the reviewers; for instance, both SocioFile and PsycInfo provide much 

more complete indexing coverage of the key journal Sexuality and Disability then does Medline, 

and so these databases were included. 

The databases searched were Medline (1966- June Week 1 2003), Premedline (June 13 2003) 

and CINAHL (1975 to June Week 1 2003) using Search Strategy 1, and Cochrane Central 

Register of Controlled Trials, (1st Quarter, 2003), SocioFile (1974 to June 2003) and PsycInfo 

(1887 to June Week 1 2003) using Search Strategy 2. 

Following the suggestions of the technical expert panel the proceedings of the following 

associations were searched for the years 1997 and 2002 (inclusive): American Urological 

Association, International Society of Sexual and Impotence Research, International Society for 

the Study of Woman's Sexual Health American Paraplegia Association, American Association of 

Spinal Cord Injury Nurses, American Association of Spinal Cord Injury Psychologists and Social 

Workers, American Association of Sex Educators, Counselors and Therapists, American Spinal 

Injury Association, American Academy of Physical Medicine and Rehabilitation, and American 

Congress of Rehabilitation Medicine. 

At the suggestions of the technical expert panel and in addition to Eli Lilly Canada Inc. 

(producer of Cialis) and Bayer Group (producer of Levitra), the following manufacturers were 

also contacted: Unimed Pharmaceuticals Inc., Mentor Corporation, Vivus Inc., Timm Medical 

Technologies, Schering-Plough Corporation, Pfizer, Sabex 2002 Inc., and Novartis 

Pharmaceuticals. 

The search strategy was identical to that used in the UO-EPC phase 1 feasibility study. 

8 
Eligibility Criteria 

Published and unpublished studies, reported in English, involving any research design (e.g., 

randomized controlled trials [RCTs]), language of publication, and enrolling both male and 

female, adult and adolescent populations with SCI, were eligible for inclusion if each also met 

the criteria outlined in Table 2. 

Table 2: Inclusion criteria 

Parameter Reproductive health Male sexuality

Design Does the article discuss a fertility

intervention; does the article include 

pre and post intervention fertility

rates; does the article contain an 

original report of a measure of fertility

rates in males, females or both; and 

does the article report an original 

intervention trial after spinal cord 

injury?

Does the article report an original 

intervention trial or series with a pre 

and post measure for sexual

dysfunction after spinal cord injury?; 

does the article contain an original

report of a measure of sexual

dysfunction?; and does the article 

discuss an intervention for sexual 

dysfunction?

Intervention Physical: masturbation, intercourse; 

Device: vibration, electrode 

ejaculation, home insemination; 

Prescription medications:

sympathetic agonists, 

physostigmine, etc.; Surgical 

intervention; vas aspiration, testicular 

biopsy, ICSI, artificial insemination, 

spinal cord stimulators; or Laboratory 

techniques.

Cognitive/behavioral: Masturbation, 

intercourse; Device: penile rings, 

vibrators, vacuum devices; 

Prescription medications:

Intracavernous injections, oral, 

subcutaneous injections, intrameatal 

MUSE, creams; surgical intervention;

penile implants, spinal cord

stimulators or hormonal 

interventions.

Outcome Pregnancies, live birth rates, sperm 

motility, successful sperm 

harvesting, ejaculations, sperm 

count, % viable sperm, hormonal, 

ovulation rates, cycle function, other 

measures of sperm morphology, 

volume of ejaculation. 

Psychological: Validated sexual 

function questionnaire for males 

and/or females, structured interviews

with qualitative analysis, educational 

component, global efficiency, or 

patient logs; or Physiologic: Penile

and/or clitoral engorgement, 

endocrine, ultrasound testing of 

testicular size.

Study Selection Process 

All results of searches for evidence were provided to reviewers for screening against 

eligibility (inclusion/exclusion) criteria. As an extension of the phase I feasibility study, two 

reviewers were employed at the relevance assessment phase of the evidence review. Two levels 

of screening for relevance were used, with the first level directed at bibliographic records during 

phase I, the feasibility study (i.e., title, authors, key words, abstract), and the second level 

focused on those “full report” articles retrieved based on the results of the first level of screening. 

Screenings for relevance, assessments of study quality, and data abstraction were completed 

using the UO-EPC’s review management Internet-based software which resides on a secure 

website. In the case of relevance assessment, the software simultaneously presents the 

bibliographic record to be screened and the eligibility questions with which to do so. 

9 
Following a calibration exercise which involved screening ten sample records using an 

electronic form developed and tested especially for this review (Appendix B), two reviewers 

independently broad screened the title, abstract, and key words from each bibliographic record 

for relevance by liberally applying the eligibility criteria. The record was retained if it appeared 

to contain pertinent study information. If the reviewers did not agree in finding at least one 

unequivocal reason for excluding it, it was entered into the next phase of the review. The 

reasons for exclusion were noted using a modified QUOROM format (Appendix C).28 The 

screening process also identified which of the two questions the record addressed. 

Reports were not masked given the equivocal evidence regarding the benefits of this 

practice.29,30 To be considered relevant at this second level of screening, all eligibility criteria 

had to be met. Disagreements were resolved by forced consensus and, if necessary, third party 

intervention. Excluded studies were noted as to the reason for their ineligibility (see List of

Excluded Studies at the end of the report). 

Data Abstraction 

Following a calibration exercise involving two studies, two reviewers independently 

abstracted the contents of each included study using an electronic Data Abstraction form

developed especially for this review (Appendix D). Once a reviewer completed their work, they 

then checked all of the data abstracted by their counterpart. Data abstracted included the 

characteristics of the: 

• report (e.g., publication status, language of publication, year of publication); 

• study (e.g., sample size; research design; number of arms); 

• population (e.g., age; percent males; diagnosis description); 

• intervention/exposure (e.g., Viagra® for sexual function; testicular biopsy for fertility 

rates); 

• withdrawals and dropouts. 

Summarizing the Evidence 

Overview 

The evidence is presented three ways. Evidence tables in the appendices offer a detailed 

description of the included studies (e.g., study design, population characteristics, 

intervention/exposure characteristics), with a study represented only once. The tables are 

10 
organized by research question and design (e.g., RCTs with male sexuality interventions; 

observational studies examining male sexuality interventions; observational studies examining 

fertility rates; etc.). 

Question-specific summary tables embedded in the text report each study in abbreviated 

fashion, highlighting some key characteristics, such as comparators and sample size. This allows 

readers to compare all studies addressing a given question. A study can appear in more than one 

summary table given that it can address more than one research question. 

Study Quality

Evidence reports include studies of variable methodological quality. Differences in quality 

across and within study designs may indicate that the results of some studies are more biased 

(i.e., systematic error) then others. Systematic reviewers need to take this information into 

consideration to reduce or avoid bias whenever possible. There is considerable evidence that 

low-quality reports, compared with higher quality ones, can introduce bias into the estimates of 

an intervention’s effectiveness.31 In this report, study quality was assessed through examination 

of each individual report. No attempt was made to contact the authors of any report. Quality 

was defined as the confidence that the study’s design, conduct, analysis, and presentation has 

minimized or avoided biases in any comparisons.32 Several approaches exist to assess quality: 

components, checklists and scales. For this report, we have elected to use a combination of 

methods in an effort to ascertain a measure of reported quality across different study designs. 

For RCTs the Jadad scale was used (Appendix D). This validated scale includes three items

that assess the methods used to generate random assignments, double blinding, and a description 

of dropouts and withdrawals by intervention group.33 The scoring ranges from one to five, with 

higher scoring indicating higher quality. In addition, allocation concealment [i.e., keeping the 

randomization blind until the point of allocating participants to an intervention group] was 

assessed as adequate, inadequate or unclear (Appendix D).34 An a priori threshold scheme was 

used for sensitivity analysis: a Jadad total score of ≤ 2 indicates low quality with scores > 2 

indicating higher quality; for allocation concealment, adequate = 1, inadequate = 2 and unclear = 

3. 

Cohort and case-control study reports were assessed using the Newcastle-Ottawa scale 

(NOS). The NOS is an ongoing collaboration between the Universities of Newcastle, Australia 

and Ottawa, Canada. It was developed to assess the quality of nonrandomised studies with its 

design, content and ease-of-use directed to the task of incorporating the quality assessments in 

the interpretation of meta-analytic results. A “star system” has been developed in which a study 

is judged on three broad perspectives: the selection of the study groups; the comparability of the 

groups; and the ascertainment of either the exposure for case-control studies, or the outcome of 

interest for cohort studies. The goal of this project is to develop an instrument providing an easy 

and convenient tool for quality assessment of nonrandomised studies to be used in a systematic 

review. 

The inter- and intra-rater reliability of the NOS have been established. The face content 

validity (i.e., the extent to which the instrument appears reasonable on superficial inspection) of

the NOS has been reviewed based on a critical review of the items by several experts in the field 

who evaluated its clarity and completeness for the specific task of assessing the quality of studies 

to be used in a meta-analysis. Further, its criterion validity has been established with 

comparisons to more comprehensive but cumbersome scales. The NOS developers continue to 

11 
develop appropriate measurement properties for the instruments’ development.27 Quality 

assessments of non-comparative case series reports were assessed using a 19-item instrument 

adapted from Opthalmology (Appendix D).2

 We did not conduct any sensitivity analysis of

quality assessments on the observational studies, as there is little by way of guidance to suggest 

what a poor quality study’s score would be based on for these assessment instruments.

Qualitative Data Synthesis 

A qualitative synthesis was completed for all studies included in the evidence report. A 

description is provided of the progress of each citation through the review process, and includes 

information pertaining to each report, such as their sample size. The qualitative synthesis was 

performed on a question-specific basis, with studies grouped according to research design (e.g., 

RCTs, observational studies). Each synthesis includes a narrative summary of the key defining 

features of the study report, if stated, (e.g., a priori description of inclusion/exclusion criteria), 

population (e.g., diagnosis-related), intervention/exposure (e.g., use of Viagra®), outcomes, 

study quality, applicability, and individual study results. A brief study-by-study overview 

typically precedes a qualitative synthesis. 

Quantitative Data Synthesis 

For several of the questions investigated in this evidence report, quantitative data synthesis 

was deemed appropriate. However, most of the studies were non-comparative case series and 

outcomes were in the form of single proportions (e.g. proportion of couples achieving at least 

one pregnancy). Current meta-analytic methodology generally focuses on data from studies that 

include a control group, such as randomized controlled trials. From a meta-analytic perspective, 

one of the strengths of studies that include control groups is that even if there is some degree of 

heterogeneity in characteristics such as population or intervention across studies, there may be 

little statistical heterogeneity in the contrast between outcomes in the treatment and control 

groups across studies. This protection against heterogeneity is not available in studies without a 

control group. Judicious selection of comparable studies for inclusion in a meta-analysis of

single proportions therefore becomes especially crucial. Random effects techniques for pooling 

results attempt to adjust for the presence of statistical heterogeneity, but necessarily provide 

weaker inferences, and do not obviate the need for careful investigation of sources of statistical 

heterogeneity. 

In the present work, heterogeneity of single proportions was assessed using Pearson's chisquare test. P-values less than 0.10 were taken to indicate statistically significant heterogeneity. 

Forest plots were constructed using Wilson score confidence intervals around individual study 

proportions.35 Pooled estimates and their confidence intervals were obtained using the random

effects estimator of Laird & Mosteller.

36

12 
 

Note: Appendixes and Evidence Tables cited in this report are provided electronically at 

http://www.ahrq.goc/clinic/epcindex.htm 

13

 

Chapter 3. Results 

Results of Literature Search 

A total of 2,420 bibliographic records were retrieved through database searches (QUOROM 

flow chart, Appendix C). After duplicate records were removed, 2,082 unique items remained. 

An additional 46 potentially relevant studies were identified through conference abstracts or 

were nominated by manufacturers. A total of 2,128 reports were evaluated against the eligibility 

criteria and after the initial screening for relevance, 1,627 records were excluded. Although the 

majority of the initial screening was performed in the phase I feasibility study,37 the additional 

studies that were identified when the search was “rerun” at the beginning of this study (n = 98, of 

which 47 were duplicates) were screened according to phase I criteria. The reasons for exclusion 

were: not relevant to SCI (n = 530); not relevant to sexuality or reproductive health (n = 410); 

case report or opinion piece (n = 282); no relevant measure reported (n = 271); not relevant to 

any of the questions (n = 78); and, report pertaining to adolescent or child only (n = 6). The 

remaining 501 reports were then retrieved and subjected to a more detailed relevance assessment. 

Two hundred and forty-five of these reports dealt with issues relating to fertility and 289 of the 

reports examined sexual dysfunction. After further relevance assessment, 180 of the 246 reports 

on fertility and 232 of the 289 reports on sexual dysfunction failed to meet the inclusion criteria. 

The reasons for exclusion are listed in the QUORUM flow chart (Appendix C). In total, 122 

reports were deemed relevant for the systematic review—66 of the reports examined fertility and 

56 reports examined sexual dysfunction in individuals with SCI. The Evidence Tables are 

presented in Appendix E. Evidence Tables1 to 3 present the fertility rate evidence from noncomparative case-series studies (Evidence Table 1), case-control studies (Evidence Table 2) and 

conference proceedings (Evidence Table 3). Evidence Tables 4 to 6 outline the evidence from 

RCTs (Evidence Table 4), other study designs (Evidence Table 5) and conference proceedings 

(Evidence Table 6), regarding the use of sildenafil (Viagra®). 

Report and Study Design Characteristics of Included Studies 

The 122 studies included 6,668 individuals1

, ranging in age from 16 years to 81 years, of 

which 78% of the studies enrolled only men and 6% of studies reporting all female 

participation.2

 

As might be expected, the complete spectrum of SCI severity was represented in the included 

studies. Eighty-seven studies (71%) reported on the level of lesion; 18 (15%) reported on the 

American Spinal Injury Association level of injury. With regards to the reporting of severity of 

1

 “Couples” were counted as a single case when pertaining to number of participants enrolled. 2

 14% of the included studies reported on the enrollment of couples only or together with single-case male participants. 
injury, inconsistencies were observed between studies. The majority of studies used a noncomparative study design (61%) to address the question under consideration; for example, 

studies examining ejaculation rates in men with SCI typically did not include a comparator group 

but reported only on specific outcomes of a particular intervention to improve ejaculation rates. 

Few RCTs were identified that evaluated the efficacy of male sexual dysfunction, and the 

majority of these were duplicate publications. The quality of reporting of the 122 included 

studies was less than optimal. For example, of the 75 non-comparative studies, none reported on 

all of the quality items that were used to evaluate the reports. The highest number of quality 

criteria met was 16/19 items, and this was achieved by only one (1%) of the 75 studies. 

Fertility in Females After SCI 

There were no studies found that investigated this question. 

Fertility in Males After SCI 

We identified 22 non-comparative case series, including 806 men, which addressed 

ejaculation rates in men with SCI using vibration or electroejaculation.38-59 Three other caseseries studies directly examined differences between the two techniques.60-62 We identified two 

articles that described the details of electroejaculation techniques and precautions in SCI males; 

however, these studies did not specifically address any of the questions posed by the 

consortium.

63,64

Several authors reported results of electroejaculation and/or vibration studies using numerical 

breakdowns that could not be pooled.24,65,66 Koletis et al. described his clinical results with 

electroejaculation in some detail, but did not define the ejaculatory outcomes well, or report the 

incidence of side effects.24 Likewise, several abstracts either did not describe results in sufficient 

detail to abstract the data,65,66 or more complete description of the data was found in other 

publications.67

The use of physostigmine injection for ejaculation is described in two articles involving 57 

SCI males.68,69

We identified 18 non-comparative case series, including 398 couples, reporting on 

pregnancies and/or live births.41,44,48,50-55,57-59,69-74

 One additional case series describing IVF after 

electroejaculation included SCI patients but did not adequately breakdown the success rates by 

diagnosis.75

Nine studies involving 294 SCI males were designed to look at specific effects of medical 

and physical factors on SCI male fertility;

56,76-83 however, these studies did not specifically 

address any of the questions posed by the consortium.

Five studies reporting on 69 SCI males described other more invasive techniques used to 

harvest semen.84-88 

Finally, a further 12 articles reported on semen examination techniques or on various semen 

characteristics in SCI males, often to further delineate reasons for infertility and discuss possible 

treatments.83,89-99 However, these studies did not address specifically any of the questions posed 

by the consortium. These articles are referred to again in the discussion as they highlight 

treatment implication. 

14 
Interventions for Female Sexual Dysfunction 

We identified seven studies—six case-control studies6,100-104 and one RCT105—including 132 

females with SCI, that addressed interventions for female sexual dysfunction. 

Male Sexual Dysfunction 

We identified four studies, of which three were non-comparative case-series studies106-108 and 

one was a placebo-controlled clinical trial,109 that evaluated the use of topical agents (n = 53 

patients) for sexual dysfunction in men with SCI. Eight studies, all of which were noncomparative case-series studies, examined intracavernous injections (n = 273).110-117

 Five caseseries studies evaluated penile implants (n = 363).118-122

 Nine studies, of which two were 

RCTs123,124 and seven were case-series studies,125-131 evaluated Viagra® (n = 627). The 

remaining studies examined the use of other interventions for male sexual dysfunction including: 

behavioural methods (one case series132; n = 10); intraurethral Alprosatadil (two noncomparative case series;

133,134 n = 30); vacuum devices (two case series;135,136 n = 50); sacral 

stimulators (one case series;137 n = 33); side effects associated with Viagra® (10 studies—five 

RCTs123,138-141

 and five case-series studies126-128,130,131) and, side effects associated with 

intracavernous injections of prostaglandin and/or papaverine (seven studies—six noncomparative case-series112,113,115-117,142

 and one RCT;143 n = 287). In one methodological article, 

rectal probe electrical stimulation is described as a treatment for erection.64 In 1998, Potter144

describes a non-statistical trend to improvement in sexual function with fampiridine SR (4-

aminopyradine) in a small group of 29 patients . 

We identified two studies that described the psychosocial benefits of treating impotence in 

SCI males;145,146 however, these studies did not specifically address any of the questions posed 

by the consortium. In 1992, Jaworski and colleagues used a case-control study design to 

describe a positive impact on marital relationships in 30 couples post-penile implant or

intracavernous injection, and in 1993, Richards et al. used a noncomparative case-series design 

to describe similar results in 17 couples.145,146 Both emphasized the need for a wider approach to 

treating relationship issues after SCI, rather than emphasizing erectile function alone. 

General Results 

Although a large body of literature exists regarding sexuality and SCI, some general 

observations should be made. First, the literature includes many reports of nonoriginal data or 

summaries of previously published work. Multiple review articles exist and sometimes new 

case-series data is added to previous work within a review article. Although we highlight such 

articles, we were unable to use this data in either our summary or pooled analysis since we could 

not determine the quality of the articles without complete information on the source of the data. 

Second, most comparable data for treatment intervention is presented in case-series format. 

It is of course impossible to conduct RCTs for fertility interventions as clients are unlikely to 

subject themselves to invasive interventions in self-paying clinics on a random basis. It is also 

difficult to conduct RCTs for many of the previously invasive sexual dysfunction treatments 

such as injections and implants, since subjects are unlikely to inject unknown substances into 

15 
their penises or undergo disfiguring surgery in a trial. Nevertheless, the quality of reporting of 

many of these case-series studies could have been improved with simple reporting of complete 

methodology, including how missing data is dealt with, reports on dropouts, follow-up efforts 

and consistent reporting on side effects. 

Finally, the RCTs included in this report suffer due to inconsistent and often incomparable 

outcome measures preventing pooling of the relevant data. In addition, there is an unfortunate 

tendency for duplicate publication, whereby data from the same group of patients, but on 

different aspects of the same trial, is published multiple times in different journals, with the 

author list rearranged. This results in the false impression that more studies exist with an overall 

larger group of patients. 

We will discuss the results relating to each of the questions posed by the consortium.

Question 1. What is the Current Fertility Rate for Men and 

Women After SCI? 

Fertility in Females After SCI. 

There were no studies found that investigated this question. 

Fertility in Males After SCI 

Ejaculation rates. Different aspects of male infertility have been studied. Reports in the 

literature on this topic can be grouped, and some information pooled. Much of the earlier work 

in this area centers around interventions to aid males with SCI to ejaculate, either during sexual 

activities with their partners or in a clinic situation to harvest semen for implantation. Different 

authors and clinics have chosen different methodologies to aid ejaculation in males with SCI. 

They include intrathecal or subcutaneous physostigmine with masturbation, penile vibration 

techniques with or without pharmacologic enhancement, or electroejaculation. 

In 1992, Leduc et al.69 published the largest study to date of physostigmine in 37 patients 

with SCI. Side effects included ten episodes of autonomic dysreflexia, five episodes of nausea 

and vomiting, one episode of hallucination and one episode of dizziness. Patients required 

multiple medications to inhibit the side effects of physostigmine. Only antegrade ejaculation 

was counted and the success rate was 54%. The success rate of physostigmine was lower then 

that obtained with the other techniques described below, and physostigmine also demonstrated a 

significantly higher side-effect profile. This drug is now very difficult to obtain and this 

procedure should be considered for historical reference only. 

The most common techniques used for semen harvesting include vibration or electrode 

ejaculation techniques. Many clinics do both procedures, starting with vibration and then going 

to electrode ejaculation if vibration is unsuccessful. We identified 22 case-series studies that 

used these techniques. These studies originated in the US, UK and Australia, encompassed a 

total of 806 patients, and spanned the time period from 1981 to 2002.38-59 These case-series 

studies ranged in quality from 2/19 to 12/19 (Summary Table 1). Fourteen percent of the above 

studies met 11 of 19 (58%) quality criteria. 

16 
We were able to pool ejaculation results from 22 of these case-series studies that used 

vibration and/or electrode stimulation in males with SCI (Figure 1). Overall, these interventions 

resulted in an overall ejaculation response rate of 86% (random effects pooled estimate: 0.86 

95% C.I. 0.80, 0.93). It is worth noting that with the exception of the study by Chung et 

al.,54studies published from 1997 onwards report response rates of 100%. When data from

studies examining vibration and/or electrode stimulation to provoke ejaculation are pooled, a 

large degree of heterogeneity is observed. This observation reflects the inclusion of early studies 

that were aimed at establishing optimal parameters for the technique (e.g., vibration amplitude, 

electricity parameters), as well as the inclusion of more recent studies which implemented the 

now common practice of first starting with vibration and later including electroejaculation to 

increase success rates. 

17 
Figure 1: Meta-Analysis—Ejaculation 

Figure 1: Forest plot of the success rate of vibration and/or electrode stimulation in noncomparative caseseries studies that reported ejaculation as an outcome. The data was pooled and the overall estimate 

and its confidence interval was calculated using the random effects estimator of Laird & Mosteller. 36

Quality scores are out of a possible 19. Estimates from studies prior to 1993 are denoted by open circles. 

Only results from the past 10 years (1993-2003) were pooled to account for changes in techniques and 

technology. 

Percent succeeding

0 20 40 60 80 100

Brindley, 1981 

Author, Year

Brindley, 1981 

Brindley, 1984 

Halstead, 1987 

Sarkarati, 1987 

VerVoort, 1988 

Beretta, 1989 

Lucas, 1991 

Rawicki, 1991 

Mallidis, 1994 

Lim, 1994 

Hultling, 1994 

Sonksen, 1994 

Pryor, 1995 

Dahlberg, 1995 

Nehra, 1996 

Chung, 1997 

Sonksen, 1997 

Chen, 1999 

Taylor, 1999 

Pryor, 2001 

Heruti, 2001 

24 / 37

Proportion

50 / 84

48 / 81

10 / 12

29 / 34

7 / 7

72 / 102

11 / 12

24 / 38

7 / 7

12 / 12

12 / 12

58 / 66

6 / 6

29 / 35

66 / 78

25 / 27

28 / 28

14 / 14

19 / 19

11 / 11

84 / 84

2 

Quality

5 

6 

12 

10 

10 

11 

6 

7 

8 

10 

6 

9 

5 

7 

7 

9 

9 

9 

7 

10 

11 

Random effect

pooled estimate

18 
Reports of other techniques used to harvest semen from males with SCI were identified 

(Summary Table 1) and include: electrical stimulation of the seminal vesicles and vas deferens;84

vas cannulation with implanted sperm reservoirs;85 testicular biopsy;86,87 and microsurgical 

aspiration of the vas deferens.88

Summary Table 1: Success rates of various techniques used to obtain semen in men with SCI 

Author, Year Study Design Number of 

patients 

Technique Success rates Quality

Bensman & 

Kottke, 1966 

Noncomparative 

case series 

5 Electrostimulator Sperm obtained in 3/5 from 

retrograde ejaculate; no 

motile sperm in 2/5; in 1/3 

with 410K sperm/cm4, 20-

30% of the sperm had 

abnormal forms 

4/19 

Brackett et 

al., 2000 

Case-control 12 Vas aspirated to

ejaculated sperm 

Vas aspirated sperm motility 

and viability plus or minus 

standard error of mean were

significantly higher than 

mean ejaculated sperm 

motility and viability (54.4% 

+/- 5.0% and 74.1% +/- 5.3% 

versus 14.1% +/- 2.6% and 

26.1% +/- 4.9%, 

respectively) 

7* (NOS) 

Brindley et 

al., 1986 

Noncomparative 

case series 

12 Implanted sperm

reservoir 

8 pts (67%) motile 

spermatozoa were recovered 

2 pregnancies (17%) 

achieved with subsequent 

live births (by AIH). 

6/19 

Hirsch et al., 

1994 

Case-control 10 Testicular biopsy Spermatogenesis similar 

between SCI men and 

controls 

4* (NOS) 

Perkash et 

al., 1985 

Noncomparative 

case series 

30 Electrical stimulator Sperm count in n=18 men 

>40 million 

Total sperm count in 22 pts 

>20 million 

Normal Sperm morphology: 

mean 55%, range 40-75% 

Sperm progressive motility 

<20% in 27 of 35 specimens 

No motile in 10 specimens & 

less than 10% motile in 13; 

10%-20% motile in 4 pts; 

>30% motile in 5 pts 

7/19 

NOS = Newcastle Ottawa Scale 

Pregnancies and live births. Not all authors chose to present both pregnancy and live birth 

data. However, there is no suggestion in the literature that the spontaneous abortion rate of a 

pregnancy conceived from an SCI male exceeds that of the general population; therefore, we 

chose to combine both sets of data. These results represent the number of couples who have 

achieved at least one pregnancy or live birth over the number of couples who tried to conceive. 

It is very important to note that some authors reported their fertility rates after very simple 

procedures such as vibration or electrode ejaculation, whereas some studies were performed in 

clinics that greatly increased the odds of achieving pregnancy by adding a variety of advanced 

fertility techniques. 

19 
Seventeen studies published between 1987 to 2001, involving a total of 400 patients from the 

US, UK and Australia, have documented pregnancy rates.41,44,44,48,48,50,51,51,52,52-54,54,55,55,57-

59,59,69,69-71,71,72,72-74,147

 Thirteen studies published between 1991 to 2001, involving a total of 341 

patients from Canada, US, UK and Australia, have documented live-birth rates.70 Eleven of 

these studies overlap and report both pregnancy and live-birth rates.44,48,51,52,54,55,59,69-72 

Data from the 17 studies documenting pregnancy rates were pooled and indicate pregnancy 

rates of 51% (random effects pooled estimate: 0.51 95% C.I. 0.42, 0.60) (Figure 2). The data 

suggest considerable improvement in pregnancy rates, from the dismal 0% reported by Halstead 

in 198741 to the more recently reported rates of 74%57 and 73%.58 The quality of these studies

ranges from 5/19 to 12/19 (Summary Table 3). Twenty percent of the pregnancy studies met 11 

of 19 (58%) quality criteria. Data from the 13 studies documenting live-birth rates were pooled 

and indicate live birth rates of 40% (random effects pooled estimate: 0.40 [95% C.I. 0.33, 0.48]) 

(Figure 3). The heterogeneity of these pooled results is explained by the addition of advanced 

fertility techniques that increase the success rates for these endeavors by up to four times, 

compared with insemination alone. Once again, an improvement in live birth rates over time has 

occurred with Lucas reporting a success rate of fourteen percent in 1991 and Elliot of sixty-two 

percent five years later. The quality of these studies ranges from 5/19 to 12/19 (Summary Table 

4). Eight percent of the live birth studies met 11 of 19 (58%) quality criteria. 

20 
Figure 2: Meta-Analysis—Pregnancy

Percent succeeding

0 20 40 60 80 100

Halstead, 1987 

Beretta, 1989 

Lucas, 1991 

Leduc, 1992 

Hultling, 1994 

Pryor, 1995 

Brackett, 1995 

Dahlberg, 1995 

Nehra, 1996 

Hultling, 1997 

Chung, 1997 

Sonksen, 1997 

Brinsden, 1997 

Taylor, 1999 

Pryor, 2001 

Heruti, 2001 

Ohl. 2001 

0 / 4

3 / 6

1 / 10

3 / 6

6 / 12

5 / 6

11 / 23

18 / 35

17 / 33

16 / 25

7 / 27

10 / 28

18 / 35

14 / 19

8 / 11

18 / 33

28 / 87

12 

11 

6 

6 

6 

5 

10 

7 

7 

9 

9 

9 

9 

7 

10 

11 

6 

Author, Year Proportion Quality

Random effect

pooled estimate

Figure 2: Forest plot of the success rate for pregnancy in the noncomparative case-series studies that 

reported pregnancy as an outcome. The data was pooled and the overall estimate and its confidence 

interval was calculated using the random effects estimator of Laird & Mosteller.36 Quality scores are out 

of a possible 19. Estimates from studies prior to 1993 are denoted by open circles. Only results from the 

past 10 years (1993-2003) were pooled to account for changes in techniques and technology. 

21 
Figure 3: Meta-Analysis—Live Birth 

Percent succeeding

0 20 40 60 80 100

Lucas, 1991 

Leduc, 1992 

Buch, 1993 

Hultling, 1994 

Brackett, 1995 

Dahlberg, 1995 

Nehra, 1996 

Hultling, 1997 

Chung, 1997 

Sonksen, 1997 

Brinsden, 1997 

Heruti, 2001 

Elliott, 2002 

1 / 7

3 / 6

2 / 6

2 / 10

8 / 23

14 / 35

17 / 33

11 / 25

4 / 27

9 / 28

14 / 35

18 / 33

45 / 73

6 

6 

8 

6 

10 

7 

7 

9 

9 

9 

9 

11 

8 

Author, Year Proportion Quality

Random effect

pooled estimate

Figure 3: Forest plot of the success rate of live birth in noncomparative case-series studies that reported 

live birth as an outcome. The data was pooled and the overall estimate and its confidence interval was 

calculated using the random effects estimator of Laird & Mosteller.36 Quality scores are out of a possible 

19. Estimates from studies prior to 1993 are denoted by open circles. Only results from the past 10 

years (1993-2003) were pooled to account for changes in techniques and technology. 

22 
Are Fertility Rates Changed After Freezing a New Patient's Sperm? 

Only one study indirectly addressed this question (Summary Table 2). In 1994, Padron et 

al.148 evaluated the effect of cryopreservation on the quality of sperm in SCI males, and 

determined that semen obtained from SCI males freezes as reliably as semen obtained from

“controls.” However, for both groups, when the optimal method of vapor freezing was used 

there was still a reduction in sperm motility of approximately 65%. This reduction in motility 

would obviously be more significant for the SCI group, a group that already has reduced sperm

motility as a characteristic of its semen quality. 

Summary Table 2: Study examining the impact of freezing sperm 

Author, Year Study

Design

Number of 

patients 

Fertility Rate Quality

Padron et al., 1994 Controlled

clinical 

trial 

9 Frozen sperm from SCI men 

retain motility similar to that 

of normal men

Not applicable

(non-RCT)

Are There Better Fertility Rates Using Electroejaculation or Vibration? 

Does Order of Method Influence Outcome? 

We identified four trials that directly compared vibration and electroejaculation for inducing 

ejaculation in SCI males.60-62,149

 In a controlled clinical trial published in 1997, Brackett et al.61

collected semen using vibration and/or electroejaculation from 77 males with SCI. Although 

total semen volume and sperm counts were similar, the percent motile sperm and percent sperm

with rapid linear motion were significantly higher in the vibration-induced samples. This was 

observed for the vibration compared to electroejaculation groups, as well as within the ten 

patients who had both procedures performed. This study was a non-RCT and therefore could not 

be quality assessed using the Jadad scale. 

In the same year, Ohl et al.60 published results from an RCT that used both vibration and 

electroejaculation in a random fashion to obtain ejaculate from 11 males with SCI. They found 

that the antegrade specimen of the vibration-induced ejaculate had a higher quality (i.e., more 

motility) than the electroejaculate-induced antegrade specimens, however, the electroejaculated 

group had a higher retrograde volume, evening out the total motile sperm count (greater total 

volume in electroejaculated samples, better quality in vibration induced samples). The authors 

reported that the electroejaculate group experienced more pain, and all patients preferred the 

vibration procedure. This study received a quality score of 2/5 on the Jadad scale. 

In 1998, Le Chapelain150 analysed semen samples from 39 male SCI subjects and described 

improved semen quality with vibration-induced ejaculation compared with either 

electroejaculation or physostigmine. 

Finally, Park et al.62 reported an abstract in 1999 that used a case-control design to examine 

both electroejaculation and vibration in 17 males with SCI. Although sperm quality was superior 

using vibration, this technique was unsuccessfull for those with lesions at and below T10, 

requiring electroejaculation to be used with the lower lesions.

We were unable to locate any documents demonstrating a superior fertility outcome between 

vibration and electroejaculation. Therefore, we compared the side-effect profile of the two 

procedures to determine risk-benefit (Summary Table 3). Of the 21 studies identified that 

23 
reported ejaculation rates with either technique (Figure 1), ten reported adverse events.40-

43,45,47,49,50,53,59 Often, authors combined procedures, although they did not always separate the 

side effects by procedure. However, papers that combined the procedures demonstrated that the 

vibration technique is less likely to be successful for lower motor neuron (areflexic) injuries than 

with spastic injuries, and electroejaculation is more likely than vibration to cause autonomic 

dysreflexia in patients with spastic injuries.41,43 Electroejaculation also has the added side effects 

of inflammation to the rectal mucosa47 and stimulation pain40,45,47,60 in incompletely injured 

patients. Therefore, most clinics that combine these techniques usually try vibration first 

followed by electoejaculation in the areflexic subjects that tend to not respond to vibration alone. 

It is recognized that techniques of vibration and electroejaculation, as well as techniques for 

blocking episodes of autonomic dysreflexia have changed over time and therefore the relative 

risks of the two techniques may not be comparable as described in the papers examined. 

Summary Table 3: Success rates and complications observed with electroejaculation and/or vibration

Author/Year Procedure

Success 

Ratio* Complications

Sarkarati et al. (1987) Vibration 

Electroejaculation 

29/34 Pain in 4/34 pts.(electroejaculation) 

Minor headache and/or 20 to 40 

mm.Hg increase in systolic BP

occurred in a few patients (autonomic 

dysreflexia) 

Pryor et al. (1995) Vibration 

Case 1: ephedrine, 

imipramine, sodium bicarb. 

Case 2: ephedrine and sodium

bicarb, imipramine and sodium

bicarb 

Case 3: 

Case 4: ephedrine and sodium

bicarb 

Case 5: 

Case 6: intra-uterine 

insemination 

6/6 Case 1: headaches and spasticity due 

to ephedrine, switched to imipramine 

Case 2: NR (not recorded) 

Case 3: NR 

Case 4: NR 

Case 5: NR 

Case 6: NR 

Lim et al. (1994) Electroejaculation 

Vibration 

12/12 “No incidence of severe hypertension 

due to autonomic dysreflexia”

“Post-electroejaculation proctoscopy

showed no damage to the rectal 

mucosa of any patient” 

“1 patient had significant problems with 

recurrent urinary tract infections” 

“1 pt complained of severe stomach 

cramps during electroejaculation” 

24 
Summary Table 3 (cont’d): Success rates and complications observed with electroejaculation and/or

vibration 

Author/Year Procedure Success

Ratio* 

Complications

VerVoort et al. (1988) Electroejaculation 7/7 “All patients complained of 

headache/blurred 

vision/sweating/flushing and increased

BP with no nifedipine” 

“Autonomic hyperreflexia effects 

reduced during electroejaculation with 

nifedipine” 

Sonksen et al. (1994) Vibration 

Population I – 25 pts.(Vibrator 

A, no nifedipine) 

Population II – 41pts.(Vibrator

B, nifedipine sublingual 

prophylactically) 

58/66 “Population I: 4 pts had light 

headache/no increase in BP;1 pt had 

glycerine nitrate sublingual” 

“Population II – no discomfort” 

Heruti et al. (2001) Electroejaculation 14/14 Abdominal pain or spasm in 17 

stimulations 

raised BP in 15 stimulations 

3 cases of increased spasm 

1 case of syncope 

occurred in total of 16 patients, no tx 

needed, no further complications 

Brindley (1981) Electroejaculation 50/84 7 pts experienced intolerable pain – 

procedure stopped 

Halstead et al. (1987) Electroejaculation 10/12 Mild dysreflexia (3pts) disruption of 

normal bowel program (1 pt) 

Rawicki & Hill (1991) Electroejaculation 

Vibration 

Subcutaneous physostigmine

24 pt total 

(3 pt had electroejaculation 

under general anaesthetic due

to pain) 

pts with lesions above C7

treated with labetolol 100mg or

nifedipine 10mg 

24/38 Electroejaculation: autonomic 

hyperreflexia in pts with high lesions; 

pain in pts with low lesions 

Vibration: autonomic hyperreflexia in

pts with high lesions; 1pt with 

superficial ulcer; 2 pts with superficial

trauma to the glans resulting in bruising 

Subcutaneous physostigmine: blurring

vision (4/5); nausea and vomiting (2/5); 

marijuana-like highs (2/5) 

*success of ejaculation 

To Improve Fertility Rates, When Should Invasive Techniques Such as 

Testicular Biopsy or Intracytoplasmic Sperm Injection be Used? 

Invasive techniques to enhance fertility (advanced fertility [AF] techniques) such as in vitro 

fertilization (IVF) and intracytoplasmic sperm injection (ICSI) have been used more in recent 

studies. By grouping the 18 studies above that reported either pregnancies or live births (Figures 

2 and 3) according to whether they used or did not use AF techniques, one can assess how using 

AF techniques impacts fertility rates (Summary Table 4). In doing so, one easily observes that to 

achieve pregnancy and birth rates approaching 50% or greater SCI couples need to use an AF 

technique. 

25 
Summary Table 4: Pregnancy and live birth rates for studies that used AF techniques compared with those 

that did not. 

Study N AF vs non-AF Pregnancies Live births

Brackett 1995 23 AF 11/23 (48%) 8/23 

Brinsden, 1997 35 AF 18/35 (51%) 14/35 

Dahlberg, 1995 35 AF 18/35 (51%) 14/35 

Elliot, 2002 73 AF NR 45/73 

Heruti, 2001 33 AF 18/33 (55%) 18/33 

Hultling, 1997 25 AF 16/25 (64%) 11/25 

Nehra, 1996 33 AF 17/33 (52%) 17/33 

Pryor, 1995 6 AF 5/6 (83%) NR 

Pryor, 2001 11 AF 8/11 (73%) NR 

Taylor, 1999 19 AF 14/19 (74%) NR 

Beretta, 1996 6 non-AF 3/6 (50%) NR 

Buch, 1993 6 non-AF NR 2/6 

Chung, 1997 27 non-AF 7/27 (26%) 4/27 

Halstead, 1987 10 non-AF 0/11 (0%) NR 

Hultling, 1994 12 non-AF 6/12 (50%) 2/10 

Leduc, 1992 6 non-AF 3/6 (50%) 3/6 

Lucas, 1991 10 non-AF 1/10 (10%) 1/7 

Sonksen, 1997 28 non-AF 10/28 (36%) 9/28 

NR=not reported

Are There Pregnancy Complications and Prospective Obstetric 

Management Issues for SCI Females? 

We did not find any reports that provided the necessary data for us to project the number and 

frequency of complications and other obstetric issues in females with SCI. There are numerous 

case reports, however, without the larger sample size obtained with a case-series study, it is 

difficult to conduct further research or inform practice or policy regarding this important health 

issue. 

Question 2. How has the Availability of Viagra® and Other 

Remediation Affected Sexual Dysfunction and Adjustment 

After SCI? 

By far, the majority of articles regarding sexual dysfunction after SCI are either opinion 

pieces or review articles (Appendix C; List of Excluded Studies). The only RCTs that were 

identified examined Viagra® for the treatment of erectile dysfunction. However, we did identify 

multiple case-series studies that had similar outcome measures, allowing their data to be pooled. 

Interventions for Female Sexual Dysfunction 

We found six articles that used a case-control design6,100-104

 and one article that used a RCT 

design105 to examine the phenomena of sexual arousal in response to physical and cognitive 

stimulation in women with SCI (Summary Table 5). 

The studies by Komisaruk et al.103 and Whipple et al.,104 appear to be separate reports on the 

same cohort of 16 women with SCI (n = 6 with upper SCI, n = 10 with lower SCI). In a case26 
control study published in 1997, Komisaruk and colleagues103 measured altered pain thresholds 

with genital stimulation in 16 SCI and five non-SCI females. The authors found that similar to 

their able-bodied counterparts, pain thresholds were increased with genital self-stimulation even 

in women with complete SCI. This finding led the authors to postulate that in the women with 

upper SCI, genitospinal visceral afferent pathways function (although unrecognized by the 

American Spinal Injury Association criteria) and/or there exists a functional genital afferent 

pathway that bypasses the spinal cord and projects directly to the brain. Whipple and 

colleagues

104

 studied the 16 SCI females in the laboratory during self-stimulation and reported 

that only those with lesions below T-10 experienced increases in blood pressure; no SCI subjects 

had alterations in heart rate. Three females with complete SCI experienced orgasm with genital 

self-stimulation. 

Sipski has published four case-control studies examining this topic in the most detail.6,100-102 

It is unknown, however, whether all of these patients represent new or restudied patients, 

although the outcome measures are different between the studies as the author is examining 

different phenomena. In 1996, Sipski et al.102 demonstrated that even in females with 

supposedly complete SCI (n = 10), manual genital stimulation increased their sexual arousal, 

although requiring a higher level of concentration than able-bodied controls (n = 10). In a later 

study, Sipski et al.6

 demonstrated that with manual and audiovisual stimulation combined, 

greater than 50% of SCI women (n = 68) experienced orgasms that could not be differentiated 

from able-bodied controls (n = 21). Those with complete lower motor neuron dysfunction 

affecting S2-S5 had the lowest orgasm rate, and those with preservation of sensory function in 

dermatomes T11-L2 had greatest preservation of psychogenic-mediated sexual function. In 

another study, Sipski et al.101 found similar orgasm rates among SCI women, with higher orgasm

rates observed among women stimulated with a vibrator and among women who reportedly had 

higher sexual drive and greater awareness of their anatomic sexual function. Finally, Sipski et 

al.100 demonstrated that women with complete SCI could respond with audiovisual stimulation in 

those physiologic functions that are controlled above the level of their injuries, whereas genital 

physiologic response could only be achieved by stimulation below the level of the injury. 

Overall, Sipski advocates using these data for behavioral counselling in SCI women, to help 

them achieve a higher level of sexual satisfaction by learning how their body works sexually 

after SCI. 

The six case-control studies that addressed interventions for female sexual dysfunction all 

scored equal to, or above five on the NOS, with the highest score of seven obtained by Sipski et 

al.102

Summary Table 5. Studies examining various interventions for female sexual dysfunction

Author, Year Study Design 

Number of 

Patients Quality Score 

Whipple, 1996 Case-control 21 (16 SCI/5 

controls) 

6* (NOS) 

Komisaruk et al., 1997 Case-control 21 (16 SCI/5 

controls) 

6* (NOS) 

Sipski et al., 1995a Case-control 21 (13 SCI/8 

controls) 

6* (NOS) 

Sipski et al., 1995b Case-control 35 (25 SCI/10 

controls) 

5* (NOS) 

Sipski et al., 1996 Case-control 20 (10 SCI/10 

controls) 

7* (NOS) 

Sipski et al., 2001 Case-control 89 (68 SCI/21 

controls) 

5* (NOS) 

Sipski et al., 2000 RCT 19 2/5 (Jadad) 

27 
In addition, Sipski et al. performed a preliminary RCT study that evaluated Viagra® for 

sexual dysfunction in 19 women with SCI.105 The authors found a modest physiologic effect, 

and the results of this study launched a large multicenter trial. The RCT received a quality score 

of 2 on the Jadad scale (Summary Table 8). 

Male Sexual Dysfunction 

Aside from a number of RCTs evaluating Viagra®, all of the studies that we identified which 

addressed this topic were case-series studies. The most common problems faced when trying to 

analyze this literature is that many authors chose different outcome measures. For example, 

some authors use a validated erectile grading system such as Schramek’s, whereas others used 

their own grading system; some authors used all or parts of the IEFF sexual satisfaction rating 

scale, whereas others designed their own scales. When authors use either an on/off grading 

system or a common question on the IEFF, we have pooled the data when appropriate. 

Behavioral interventions. We found only one study, a case-series study, that examined 

behavioral interventions.132 Courtois et al.132 demonstrated improvement in penile rigidity in ten 

SCI males before and after biofeedback followed by home perineal muscle training exercises. 

No measurements of sexual satisfaction were incorporated into the study. The quality score was 

11/19. 

Topical agents. An attractive alternative to either systemic medication or injected medication is 

the use of a topical vasoactive agent absorbed into the penis to stimulate erection in SCI males. 

We identified three noncomparative case-series studies106-108

 and one placebo-controlled clinical 

trial

109 that evaluated these agents (Summary Table 6). Sonsken et al.108 evaluated the effect of 

applying transcutaneous nitroglycerin to the penis in 17 males with SCI, and found that five had 

a complete (full rigidity) response, seven had a partial response, and five failed to respond to the 

treatment. Six participants experienced headache with the treatment but no other serious side 

effects developed. Beretta et al.106 performed a similar study using transcutaneous minoxidil in 

15 males with SCI, and found that only four males had sufficient erection for vaginal 

penetration, while the others had an incomplete or no response. Only one patient reported 

experiencing headache. Kim and colleagues have studied both topical papaverine109 and topical 

prostaglandin E1107 in SCI males. Both agents appeared to be quite safe, with no symptoms

reported and only a slight drop in blood pressure reported for the papaverine group. Kim et 

al.107,109 reported that cavernous artery diameter was significantly increased for both papaverine 

and prostaglandin E1 as assessed by color flow Doppler ultrasound, although only approximately 

a quarter of both groups sustained a clinical erection with the treatment and there are no reports 

of using the medication during sexual activity. 

Summary Table 6. Evidence for the use of vasoactive agents to stimulate erection in men with SCI 

Author, Year Topical Substance Response Quality Assessment 

Beretta, 1993 Transcutaneous Minoxidil 4/15 had full erections 8/19 

Kim & McVary,

1995 

Topical prostaglandin 2/9 had clinical erections 10/19 

Kim et al, 1995 Topical papaverine gel 3/12 had full erections Not applicable

(non-RCT)

Sonsken, 1992 Nitroglycerine patch 5/17 had full erections 7/19 

28 
Intraurethral Alprosatadil. We identified two case-series studies that evaluated intraurethral 

Alprostadil (prostaglandin) in males with SCI (Summary Table 7). Bodner133,151 evaluated 

intraurethral Alprostadil in 15 males with SCI who had all responded to intracavernous injections 

of prostaglandin in the past, as measured by achieving a 5 out of 5 score on the Scrameks’s 

erectile response grading system. Patients required the addition of a penile ring in order to 

prevent systemic hypotension. Only three achieved a grade 4 erection sufficient for intercourse, 

and all three patients were dissatisfied with the quality of the erection and did not continue to use 

the medication at home. Waldbaum134 found similar results, and once again noted that the penile 

ring was necessary to prevent systemic hypotension. 

Summary Table 7. Evidence for the use of intraurethral Alprostadil to stimulate erection in men with SCI 

Author, Year N Results Quality Assessment

Bodner, 1999 15 3/15 achieved erections sufficient 

for intercourse 

8/19 

Waldbaum, 1998 15 4/15 achieved erections sufficient 

for intercourse 

Not applicable

(abstract) 

Intracavernous injections. Intracavernous (penile) injections of vasoactive substances have 

reported to treat SCI male impotence in the literature for several decades. Injected substances 

include papaverine, phentolamine, prostaglandin E1, or combinations of two or three of the 

above. Many clinics use combination therapy (papaverine, phentolamine, prostaglandin E1) for 

economic reasons, and there is no clear difference in efficacy between these substances. 

Using “satisfactory erection” as a common outcome measure we were able to pool data from

eight noncomparative case-series studies performed from 1987 to 1999, and involving a total of 

263 patients (Figure 4).110-117 These studies took place in the US, Australia, Italy, India, China 

and France. Overall these interventions resulted in a 90% satisfactory erection response rate 

(random effects pooled estimate: 0.90 [95% C.I. 0.83, 0.97]). One notes the very high success 

rates for these injections in males with SCI alone as a cause for their erectile dysfunction. 

The studies by Zaslau et al.115 and by Sidi et al.116 were performed in individuals with SCI 

and either hypertension or diabetes. These studies found that the combination of SCI and 

another comorbidity decreases the efficacy of the injections. 

The quality of these studies ranged from 6/19 to 13/19. Thirty-eight percent of the 

intracavernous injection studies met 11 of 19 (58%) quality criteria, with the highest score 

obtained by Sidi et al.116

29 
Figure 4: Meta-Analysis—Intracavernous Injections

Percent succeeding

0 20 40 60 80 100

Beretta, 1986 

Sidi, 1987 

Costa, 1992 

Earle, 1992 

Costa, 1993 

Kapoor, 1993 

Hirsch, 1994 

Tang, 1995 

Waldbaum, 1998 

Bonder, 1998 

Zaslau, 1999 

20 / 22

52 / 66

6 / 6

19 / 22

12 / 12

98 / 101

14 / 14

14 / 15

7 / 8

15 / 15

28 / 37

5 

13 

12 

7 

8 

10 

6 

12 

NA 

NA 

10 

Author, Year Proportion Quality

Random effect

pooled estimate

Figure 4: Forest plot of the success rate of intracavernous injections in noncomparative case-series 

studies that reported satisfactory erections as an outcome. The data was pooled and the overall estimate 

and its confidence interval was calculated using the random effects estimator of Laird & Mosteller.36 

Quality scores are out of a possible 19. 

30 
Vacuum tumescence devices. We found only two case-series studies that examined external 

vacuum pump devices for erectile dysfunction in males with SCI.135,136

In 1989, Zasler et al.135 studied a novel vacuum pump system (Synergist) that uses a silicon 

sheath in 20 males with SCI, and reported that patient and partner assessments of the device 

efficacy and sex-life satisfaction with the device were very good to excellent. Although the 

device was required to stay on during intercourse, all patients in the study had complete SCI and 

therefore diminished sensation was not an issue. However, the silicon sheath did provide some

protection for the partner. No side effects were reported. This report received a 13/19 quality 

assessment score. It is not known whether this device is still marketed. 

In 1992, Heller et al.136 studied two similar commercially available vacuum-pump systems in 

30 males with SCI. All 30 subjects were trained on how to use the device in the clinic, and then 

17 opted to purchase the device and use it at home. All 17 couples were satisfied with using the 

device during sexual activity. Some patients experienced transient testicle swelling (n = 3) and 

some experienced transient petechial hemorrhages (n = 5), although all of these side effects were 

resolved within 1 hour of use. This report received a quality assessment score of 8/19.

Penile implants. Now considered as one of the oldest treatments for erectile dysfunction, penile 

implants have been used in SCI males for decades, although with decreasing frequency. While 

this topic has been frequently discussed in opinion pieces, we found only five case-series studies 

that examined penile implants for either erectile dysfunction or erectile dysfunction plus urinary 

incontinence (Summary Table 8).118-122 These case-series studies took place in the US, Germany 

and Japan, and involved a total of over 360 SCI males. A variety of different prostheses were 

used including inflatable, semirigid, semiflexible and flexible devices. Complications included 

infections, extrusions of the devices, perforations, pain, and mechanical device failure. The 

quality scores for these studies ranged from 5/19 to 7/19.

Summary Table 8. Case-series evidence for the use of penile implants for erectile dysfunction in men with

SCI 

Author, Year N Implants Complications Quality Score

Golji, 1979 30 2 cases infection causing extrusion 

2 cases wound infections treated 

conservatively

7/19 

Green & Sloan, 1986 40 3 cases extruded rods 

1 case penile erosion 

7/19 

Gross et al., 1996 209 14 cases requiring removal of implant 

21 cases rod perforation 

5/19 

Iwatsubo et al., 1986 37 2 cases infection causing extrusion 

1 case severe pain 

1 case mechanical failure 

5/19 

Montague, 1994 47 2 cases infection requiring removal 

1 case penile erosion requiring removal 

2 cases mechanical failure 

6/19 

Sacral stimulators. Sacral stimulators have been championed by Brindley and others as a 

method of achieving continence with low voiding pressures in patients with complete SCI In 

general, the procedure is reserved for complete injuries since it necessitates a sacral rhizotomy 

with loss of a reflex erection, reflex voiding, or defecation; Brindley describes the stimulator as a 

way of voluntarily controlling these functions. We identified a single case-series study

137 that 

reported erection rates in SCI males treated with sacral stimulators for bladder control. van der 

 31
Aa et al.137,152

 reported that 29 of 33 subjects with implants could achieve a full sustainable 

erection by stimulating the S2 or S3 anterior routes. The report of this case-series study did not, 

however, state how the stimulator-induced erection impacted sexual function, or if there were 

side effects such as bladder or bowel incontinence during sexual activity. The study by van der 

Aa et al.137 received a 5/19 quality assessment score. 

Viagra® (sildafenil), RCTs. Although we originally identified nine reports of RCTs that 

examined Viagra® in males with SCI,123,124,138-141,153-155

 careful analysis revealed that only two 

of these reports were separate trials;

123,124

 the remaining studies were repeat reports in separate 

journals. Data from these trials come from the UK, France and Australia., and involve a total of 

205 male subjects with SCI (Summary Table 9). Different types of randomized trial designs, 

such as crossover and parallel, and different outcome measures were used in these studies, and 

the results were not poolable for meta-analysis. Both of these studies received a quality rating of 

3/5 on the Jadad scale. 

Summary Table 9: RCT evidence for the use of Viagra® for sexual dysfunction in men with SCI 

Author, Year, 

Location 

Number of 

subjects (N); 

Number of 

dropouts (D) Results 

Adverse

Events Quality Score 

Giuliano et al., 

1999 

France, U.K., 

Australia 

N=178 

D=7 

76% improved

erections and a 

preference for 

Viagra® vs 4% for 

placebo 

Headache: Viagra®=30, 

placebo=8 

Flushing: Viagra®=12, 

placebo=2 

Dyspepsia: Viagra®=5, 

placebo=0 

Visual effects: Viagra®=4, 

placebo=0 

Rhinitis: Viagra®=3, 

placebo=0 

3/5 (Jadad) 

Maytom et al., 

1999, UK 

N=27 

D= 0 

Erections in clinic 

>60% at base: 

Viagra®=65%; 

placebo=8%

Global Efficacy

Question (did 

treatment improve 

erections?): 

Viagra®=75%; 

placebo=7%

Headache: Viagra®=4, 

placebo=1 

Dyspepsia: Viagra®=1, 

placebo=0 

Vomiting: Viagra®=1, 

placebo=0 

Dizziness: Viagra®=1, 

placebo=0 

Rash: Viagra®=2, 

placebo=3 

3/5 (Jadad) 

Viagra (sildafenil), case series. Many of the case-series studies also used a variety of outcome

measures, however, we were able to identify seven studies that assessed the subject’s report of 

the drug improving erectile function for sexual intercourse when the drug was used at home.

125-

131 These studies took place from 1999 to 2001 in the US, Germany, Spain, Switzerland and 

Japan. Overall, Viagra® resulted in a 79% successful erectile function (random effects pooled 

estimate: 0.79 [95% C.I. 0.68, 0.90]) (Figure 4). The analysis of these noncomparative caseseries studies shows a high level of heterogeneity which is best explained by the subjective 

assessment of the outcome measure, with no standardized questionnaires being used across 

studies, and the fact that measurements were not obtained in the clinic, but rather secondhand 

from the patients “personal experience.” For the studies where quality could be assessed (i.e. full 

reports), the quality ranged from 9/19 to 16/19. The Gans et al. study,125 which met 16 of 19 

32 
(84%) quality criteria, was the only study identified by this systematic review to achieve such a 

high rating. 

Figure 5: Meta-Analysis—Viagra®

Percent succeeding

0 20 40 60 80 100

Clontz, 1999 

Kier, 1999 

Schmid, 2000 

Raviv, 2000 

Gans, 2001 

Takeda, 2001 

Sanchez, 2001 

Laschke, 2002 

9 / 12

24 / 29

38 / 41

49 / 60

16 / 17

22 / 36

150 / 170

38 / 69

NA 

NA 

10 

NA 

16 

NA 

8 

9 

Author, Year Proportion Quality

Random effect

pooled estimate

Figure 5: Forest plot of the use of Viagra® in noncomparative case-series studies that reported improved

erectile function as an outcome. The data was pooled and the overall estimate and its confidence interval 

was calculated using the random effects estimator of Laird & Mosteller.36 

Is Viagra Really More Benign Than Intracavernous Injections? 

Intracavernous injections have a significantly higher efficacy than Viagra® (90% versus 

79%). To compare the side-effect profile of intracavernous injections with that of Viagra®, we 

extracted data from the studies described above that reported side effects. Ten studies from the 

US, Europe and Japan conducted from 1998 to 2002 and including a total of over 600 patients 

33 
reported that the most common side effects observed with Viagra® were short-lived, and 

included headache, flushing and infrequent dizziness (Summary Table 10).123,126-128,130,131,138-141 

Note that all of these studies excluded patients on nitrate medications and that there were no 

reported sudden deaths. With regards to intracavernal injections, eight studies carried out from

1986 to 1999 in the US, Australia, Italy, India, China and France and studying a total of 263 

patients reported transient local side effects, such as pain and swelling at the injection site.112-

117,142,143 The most serious was priapism (prolonged erection), which can be avoided by doing 

doseage adjustments in the clinic with a reliable subject. 

Summary Table 10. Side effects associated with the use of intracavernous injection or Viagra® for sexual 

dysfunction in men with SCI 

Author, Year Intervention (number of pts) Side Effects (number of pts)

Anonymous, 

(1999) 

Viagra® (26) 2 pts with dyspepsia and respiratory

disorder 

Clontz et al., 

1999 (abstract)

Viagra® (12) visual changes (1) and headache (3) 

Derry FA et al.,

(1998) 

Viagra® (27), vibration headache (4) 

dyspepsia (1) 

dizziness (1) 

anxiety (1) 

Giuliano et al., 

(1999) 

Viagra® (178) headache (30)

flushing(12) 

dyspepsia(5)

rhinitis (3) 

abnormal vision (4) 

discontinued treatment (6) 

Kier et al., 1999 Viagra® (29) visual change (3%) 

headache (17%) 

dizziness (3%)

flushing (3%) 

Laschke et al., 

(abstract, 2002) 

Viagra® (69) headaches and flushing (25%) 

Sanchez et al., 

2001 

Viagra® (170) headache (10)

flushing (15) 

GI discomfort (7) 

nasal congestion (8) 

visual disturbances (7) 

restlessness, palpitations, hiccup, dry

mouth (9) 

unbearable abdominal pain (1) 

34 
Summary Table 10 (cont’d). Side effects associated with the use of intracavernous injection or Viagra® for 

sexual dysfunction in men with SCI 

Author, Year Intervention (number of pts) Side Effects (number of pts)

Schmid et al., 

2000 

Viagra® (41) headache(3) or dizziness(2) 

flushing (2) 

dyspepsia (1) 

blurred vision (1) 

2 withdrew because of adverse events 

Shenot et al., 1999 

(abstract) 

Viagra® (29) headache (7%)

flushing (7%) 

Takeda et al., 

2000 (abstract)

Viagra® (36) headache, facial flush, chest strangled 

feeling 

Beretta et al., 

1986 

Papaverine (22) 7 pts with prolonged erections

Earle et al., 1992 Papaverine, papaverine & 

phentolamine, prostaglandin E1 

(22) 

pain with 2 pts, one using papaverine

one using papaverine and phentolamine 

Hirsch et al., 1994 Prostaglandin E1 (14) 2 pts with subclinical corporal fibrosis 

Kapoor et al., 

1993 

Papaverine: 101 volunteers, 65

papaplegics, 36 tetraplegics 

3 subcutaneous haematoma, 2 

cavernosal fibrosis, 3 prolonged erection, 

1 systemic effects 

Renganathan et 

al., 1997 

Transdermal nitroglycerin vs 

papaverine (28)

9 pts complications with papaverine: 8 

had mild edema, 1 pt with prolonged 

erection

Sidi et al., 1987 Papaverine HCl, or combo 

papaverine/phentolamine mesylate 

(66) 

4 pts with sustained erections that 

required irrigation 

Tang et al., 1995 Prostaglandin E1 (15) 2 pts pain at injection site 

Zaslau et al., 1999 Fixed combo of prostaglandin E1 

and papaverine (37) 

2 pts stopped due to pain/ecchymosis at 

injection site 

How Does the Morbidity of Prostaglandin Injections Compare With the 

Older, Less Expensive Papaverine or Phentolamine 

Although similar in efficacy, prostaglandin E1 is less stable at room temperature and much 

more expensive than papaverine or phentolamine. Proponents cite a shorter half-life (less chance 

of priapism) and less injection-site pain and scarring as reasons to use this substance despite its 

expense. We identified six noncomparative case-series studies112,113,115-117,142 and one RCT143

that reported the numbers of side effects, and the adverse reactions are listed in Summary Table 

11. The quality of the case-series studies ranged from 5/19 to 13/19. Thirty-three percent of the 

papaverine/prostaglandin intracavernous injection studies met 11 of 19 (58%) quality criteria. 

The RCT of Renganathan et al.143 received a Jadad score of 0/5. 

35 
Summary Table 11. Side effects associated with intracavernous injections

Author, Year N treated Substance Side Effects 

Quality

Score 

Beretta et al. 

1986 

22 Papaverine 7 had priapism 5/19 

Earle et al. 

1992 

22 Papaverine, papaverine & 

phentolamine, prostaglandin 

E1 

pain with 2 pts, one using 

papaverine one using 

papaverine and phentolamine 

7/19 

Hirsch et al. 

1994 

27 Prostaglandin E1 2 had penile scarring 

detectable only on ultrasound 

after repeated use 

6/19 

Kapoor et al. 

1993 

101 Papaverine 3 had subcutaneous 

haematoma 

2 had cavernosa fibrosis after

3 years use 

1 had priapism

1 had a vasovagal reaction 

requiring dosage reduction 

10/19 

Renganathan 

et al. 1997 

28 Papaverine 1 had priapism

8 had local swelling requiring 

no intervention

0/5 (Jadad) 

Sidi et al. 1987 66 Papaverine or 

papaverine/phentolamine 

mixture 

4 had priapism

3 had minor hematomas 

1 had localized site induration 

requiring discontinuation 

13/19 

Tang et al. 

1995 

15 Prostaglandin E1 2 complained of pain at 

injection site 

12/19 

Zaslau et al. 

1999 

28 Papaverine and

prostaglandin E1 mixture 

2 complained of pain at 

injection site 

10/19 

What is the Morbidity of Vacuum Tumescence Devices? 

As described above in the two identified reports of studies of vacuum tumescence 

devices,135,136 when used with proper clinic instruction and according to the specifications of the 

manufacturers, these devices have a very low morbidity rate with no irreversible morbidity’s 

noted. Although there are case reports of penile ischemia in the literature, these case reports 

serve only as a warning not to leave the device on too long and cannot help us with ascertaining 

a complication rate. 

In a comparative cases series, Chancellor et al.156 compared vacuum-pump devices with 

papaverine injections in 18 males with SCI. The injections and pumps were equally effective 

and neither group suffered any complications during the study. After trying both treatments, 

seven patients chose to remain with the pump and another seven chose the injections. A third 

arm of this study used topical minoxidil, but unfortunately no patients achieved satisfactory 

results with this treatment. 

What Indications, if Any, Remain for Implantable Penile Prosthetic 

Devices? 

See Summary Table 8 for the results of the five case-series studies that evaluated penile 

implants in patients with SCI. It is notable that although penile implants result in a high level of 

satisfaction for those clients who do not have complications, the serious complication rate is as 

high as 10%. Furthermore, patients who have an implant removed are no longer candidates for 

other treatment options as they are likely to have damage to the penile tissues that would make 

36 
them nonresponsive to intracavernous injections or vacuum devices. These devices are, 

however, useful to assist those who need them for external application of condom drainage 

systems. They also could be used in patients who failed to respond to oral or injectable 

medications and vacuum devices, or those who find these alternatives unacceptable. 

37 

Chapter 4. Discussion 

Limitations 

Much of the literature reviewed consisted of clinic reports in case-series format, describing a 

center’s experience with a variety of treatment techniques. Although these descriptive 

experiences are valuable, they are often reported in variable formats with different outcome

measures, providing little consistency for comparative purposesacross studies. Similarly, the 

quality of reporting, especially the earlier publications, is less than optimal.

As in all scientific fields, changes in technology tend to influence, and perhaps confound the 

effectiveness of interventions. We have tried to account for this “evolution” in technology by 

pooling results from the last decade, excluding early attempts that tended to have smaller 

numbers of patients, with lower success rates. We do not wish in any way to belittle the 

groundbreaking research of these earlier pioneers, without whose efforts we would still be 

counselling our patients to “forget about sex or having children,” as was done only several 

decades ago. The pioneers encouraged us all to try to do “something,” and our own early clinical 

experience reflects this; for example, we would inject intrathecal physostigmine into patients in 

the clinic with a kidney basin nearby to catch their vomit and a test tube to catch their semen—

this before we knew that a simple modified vibrator could do the same. We hope this report 

accurately reflects the rapid evolution of this field, while respecting its history. Despite the 

somewhat high statistical heterogeneity in the pooled data, clinicians are familiar with discussing 

ranges of success with their patients, and saying that “this technique has a success rate of 80% to 

90%” is not at all uncomfortable to those who deal with biologic uncertainties. 

For fertility in males after SCI, one source of heterogeneity was a secular trend in success 

rates. For this reason, only studies from the last decade were pooled. Nevertheless, in each of 

the meta-analyses conducted in this evidence report, statistically significant heterogeneity 

remained. In the presence of statistical heterogeneity, confidence intervals for random effects 

pooled estimates are broadened to account for differences amongst the studies. However, these 

results should still be treated with caution, and we discuss other factors that may be contributing 

to the observed heterogeneity. 

Fertility in Females After SCI 

It is often stated, both in review articles and by clinician teachers at the bedside, that 

although there is an initial acute delay in the return of ovulation cycles in females following SCI, 

ultimately there is no impact on female fertility by the injury per se. Although this statement 

may be true, it is unfortunately not supported by studies comparing fertility of women with SCI 

with an uninjured cohort. There may well be unsuspected effects of SCI on the rate of 

miscarriages and live births in couples trying to have a child. A prospective, well-organized and 

 39
well-reported case-series or cohort study, potentially involving multiple centers, could provide 

valuable natural history information to answer this question. 

Fertility in Males After SCI 

In 1960, Bors and Comarr reported that males post-SCI had a fertility rate of less than 10%. 

Not surprisingly, since male reproduction is most obviously affected, the vast majority of fertility 

literature focuses on male reproduction post-SCI. In addition to this the vast majority of spinal 

cord injuries occur in men, most western nations approximately 80 percent of injured persons are 

male. Initial attempts to help infertile couples conceive a child were used to develop techniques 

to harvest sperm from the SCI male and inseminate the female partner, either using taught selfinsemination or clinic intrauterine insemination. Although successful, these efforts were 

hampered by the low semen quality often found in SCI males. Later, IVF and ICSI techniques 

were used to overcome this problem, and now patients can typically expect a stepped approach in 

a fertility clinic, where couples start with the least invasive approach and progress to the most 

invasive techniques. Although these techniques improve the chances of a successful live birth by 

up over 50%, they are extremely expensive and somewhat invasive, with female partners often 

exposed to hormonal cycle manipulation and SCI males undergoing testicular biopsies and 

aspirations. Although these risks and expenses mirror those of other infertile couples, we must 

remember that those living with SCI have additional lifelong equipment and care expenses, as 

well as reduced employment opportunities, creating financial burdens that may not allow them to 

consider these options. This financial situation has imposed a new form of limitation on 

pregnancy success. There is therefore a need for research to improve semen quality in men with 

SCI so that pregnancy may be attempted at lower cost and less invasiveness in these couples. As 

a result of this combination of expense and invasiveness, most fertility clinics utilized a stepped 

approach, going from the most natural and inexpensive and least invasive methodology to the 

enhanced fertility option in a graduated approach. This may account for some of the 

heterogeneity in the data, nevertheless we felt that it was worthwhile to pool the fertility data to 

enable us to compare the results of this type of treatment for SCI males to the fertility treatment 

for the general population. It is also recognized that in the fertility literature in general, it is 

likely that this type of heterogeneity will also be present, again influenced by invasiveness as 

well as by cost. 

Despite the fact that fertility clinic data is extremely valuable in understanding this subject 

area, many of the case-series studies published on fertility were rated low in quality. Since most 

fertility clinic data is reported in a similar fashion, the Spinal Consortium could improve the 

quality of future data by publishing guidelines on the reporting of case-series studies and casecontrol study designs. 

Original articles recounting issues of fertility after SCI describe the problem of harvesting 

semen and the poor quality of the semen as factors inhibiting success. Our review demonstrates 

that by using vibration for upper motor neuron injuries and electroejaculation for the remaining 

lower motor neuron injuries, semen can be harvested in 80% to 90% of cases. Furthermore, 

testicular biopsy or vas deferens aspiration techniques, although expensive and invasive, are 

usually successful in the remaining patients. Partner pregnancy is achieved usually using a 

stepped approach, moving from intrauterine insemination to IVF techniques with success rates 

40 
for achieving a pregnancy of up to 50%. Sperm freezing probably does little to enhance this 

process unless the sperm is frozen almost immediately after injury, usually a difficult time to 

make such life decisions. 

Sperm Quality in Males with SCI 

There has been much discussion regarding the abnormal sperm found in the ejaculate of 

males with SCI including: decreased sperm counts,87 decreased sperm motility,82,87,94increased 

reactive oxygen species formation,94 sperm autoimmunity,83 necrospermia,

91 the inhibitive effect 

of seminal plasma in SCI males,90 and the presence of antisperm antibodies.95 Methods used to 

counteract these negative effects include retrieving the semen more proximally through testicular 

biopsy or aspiration.85,88 Medical factors can also be optimized in order to try to improve sperm

quality. Chapelle et al.157 studied 135 SCI males at various neurological levels using 

physostigmine and testicular volume, and found that damage to the T12-L2 region of the cord 

(T12 metamer) correlated with testicular atrophy and poor ability to ejaculate. Three studies 

examining the effects of bladder management on sperm quality found that those men managing 

their bladders with high-pressure reflex voiding had reduced sperm quality, whereas those men 

using intermittent catheterization had the best sperm parameters.76-78 Two studies documented 

the effect of repeated ejaculation on sperm quality and demonstrated that repeated ejaculation 

improved sperm quality to a plateau, but that too frequent ejaculation (once per week) decreased 

sperm quality.79,80 They also indicated that these procedures should be timed monthly with the 

female partner’s cycle. Chen et al. compared the sperm counts in antegrade versus retrograde 

sperm samples, and found that although there was a non-statistical trend towards better sperm

counts in antegrade specimens, retrograde ejaculation occurred more frequently.56,89 Bracket et 

al. studied the effect of temperature on the semen of SCI males and found that although the 

semen of SCI males lose motility faster than the sperm of normal males, especially at higher 

(body as opposed to room) temperatures,82 scrotal temperature and gonadotropin levels did not 

contribute to poor semen quality in SCI males.81 

Although sperm motility and other aspects of fertility are seldom reported after acute SCI, 

studies show that in the chronically spinal cord injured individual (>1 year), there is no 

relationship between duration of injury and sperm quality.77-79,87 However, Mallidus et al.46

demonstrated that the sperm motility and viability first improve after the acute patient comes out 

of spinal shock then rapidly starts to deteriorate, reaching the levels observed in males with 

chronic SCI by Day 16 after injury.46 Padron,148 in a case-series study, and Green37 in a case 

report, demonstrated that although sperm from SCI males freezes reliably, there is still a great 

reduction in sperm motility. 

When these data are considered together, one can conclude that there is little to support the 

practice of freezing the sperm of SCI males after 16 days post-injury, and that even the 

advantages of early freezing (within the first 2 weeks) is outweighed by the loss of sperm

motility during the procedure, since with modern techniques one is virtually certain of obtaining 

fresh sperm from the SCI male when he is ready to conceive a child in later years. 

41 
Sexual Dysfunction in Females with SCI 

The studies done on female sexuality post-SCI, especially the thorough work done by Sipski, 

present fresh ideas and debunk old myths. Even without genital sensation, females with SCI 

have both reflex and cognitive pathways available to them to alow pleasurable experiences 

during sexual activities. Reflex pathways can be enhanced with increased stimulation (i.e. 

vibration) and cognitive behavioral therapy can enhance cognitive stimulation. Unfortunately, 

aside from a small RCT pilot with Viagra®, little has been done to study possible interventions 

along this line. Despite the early hope in the small Viagra® study, a large multicentre Viagra® 

study that has just been completed and not yet published, failed to reveal any benefit in SCI 

females with sexual arousal disorder (personal communication). 

Cognitive/behavioral therapy is often used in clinical settings to help address female 

sexuality issues after SCI, yet there are no trials to support its use. These trials could be 

conducted, and it would be useful to describe protocols to help set practice standards in this 

important area. Given the complex biosocial issues described by Sipski, it is unlikely that 

pharmaceutical treatment alone will address the problems. 

Male Sexual Dysfunction 

Although attractive conceptually, topical and intraurethral pharmaceutical agents have not 

had much success in treating individuals with SCI erectile dysfunction. However, penile 

injections with a variety of medications have proven extrememly successful. It can be noted that 

careful dosage adjustment is necessary with the papaverine or papaverine/phentolamine 

combinations. When used alone, prostaglandin E1 has few side effects outside of its cost. 

If subjects are reliable and if they have little sensation there seems to be few advantages of 

Viagra® over intracavernous injections aside from subject and partner preference. 

Although other phosphodiesterase inhibitors have come to market since sildanefil, no SCI 

treatment data for these drugs were available at the time of this review. 

Both vacuum pumps and intracavernous injections must be used with caution or not at all in 

anticoagulated patients because of the risk of hemorrhaging or bruising. Both treatment groups 

must also be monitored for priapism. Both of these complications appear to be quite rare if 

patients are first tested and instructed in the clinic before being sent home for self-treatment. 

Research and Clinical Implications 

Our review highlights some important issues in terms of how spinal cord clinical research is 

conducted. Like many other clinical content areas, there is a wide variation in the types of 

research designs used and measures used to assess similar outcomes. Although different 

approaches, particularly if they provide similar results, help to provide powerful evidence about 

the robustness of interventions, such as the use of Viagra®, there are important and often 

42 
debilitating consequences for such research development. Often, separate groups are so unique 

that the process of how their arrived at the results are disparate making it difficult to impossible 

to get a broad holistic view of the evidence base in the field. 

To help overcome these problems groups are coming together and proposing more 

standardization when conducting clinical research. The rheumatology community provides an 

excellent example through the OMERACT initiative. For example, they have agreed upon 

standard methodologies and forms to collect specific outcomes. The advantage is that clinical 

trials conducted by various groups are 'similar' in terms of design features and outcomes. As such 

this information can be combined qualitatively and quantitatively providing the strongest 

possible evidence base regarding the merits of specific interventions. Such an approach might be 

beneficial for groups trying to advance this field of research and understanding. 

Such actions are also happening for reporting clinical trials. The clinical trials community has 

moved towards a standard for reporting randomized trials. The CONSORT Statement, a 22-item

checklist and flow diagram, is now required by most major medical journals when authors are 

submitting reports of randomized trials. 

Finally, the female SCI literature describes biosocial holistic models of sexuality and, 

therefore, is ripe for trials involving multidimensional treatment modalities. The male SCI 

literature seems completely unidimensional (male sexuality + erection) and this focus deprives 

males from those same treatment options, the danger is that the clinician, when faced with a 

suffering patient, reaches into their drawer for the drug sample. Research must be driven by 

patient need—this literature is not. 

As a final point, clinicians working in this area are confronted with issues from same sex 

couples, with absolutely no literature to guide them in this discussion. Well-conducted, 

qualitative analysis work would provide a great deal of clarity in these matters, but again this 

literature is absent. 

Conclusions 

There were two general themes in this review—sexuality and fertility after SCI. These 

reviewers often found the division between these two themes to be artificial, and overlap often 

occurred. Nevertheless, we attempted to discern between the two bodies of literature. 

There is a great deal of literature in this area; however, much of the data was found to be 

repeat data (i.e., nonoriginal), and new data was incompletely reported, resulting in the evidence 

often being of poor quality. However, given these limitations and those outlined in the 

Discussion, we would like to answer the questions posed in as straightforward a manner as the 

evidence allows for: 

1. Reproductive health: What is the current fertility rate for men and women after SCI? 

For women, fertility rate is likely unaffected but little is known beyond that. For example, is 

there a higher pregnancy failure rate, or are there more or less birth deformities? 

• Are fertility rates changed by freezing a new patient’s sperm?

43 
Unless done in the first one or two weeks after SCI, and even if done earlier, this 

intervention is unlikely to make a significant improvement in SCI fertility rates, and 

therefore is not widely practiced. 

• Are there better fertility rates using electroejaculation or vibration? Does order of

method influence outcome?

The level of invasiveness is likely more of a factor than either the choice or the order. 

Vibration should be tried at least on all upper motor neuron injuries first, with 

electroejaculation reserved for those failures and the lower motor neuron injuries

• To improve fertility rates, when should invasive techniques such as testicular biopsy 

or aspiration or ICSI be pursued?

Testicular biopsy or vas aspirations should be reserved for those patients who cannot 

achieve sperm harvesting or whose harvested sperm by the above techniques is of 

very low quality. ICSI can greatly enhance success in those individuals whose sperm 

quality is insufficient for intrauterine insemination (IUI).

• Are there pregnancy complications and prospective obstetric management issues for 

SCI females?

Yes, but they are not described in the literature except in author opinion pieces and 

case reports. Comparative case series and cohort studies would add a great deal of 

information to this area.

2. Male sexuality: How has the availability of Viagra® and other remediation affected sexual 

function, frequency of activity, and adjustment after SCI?

Penile injection, Viagra® and vacuum devices can help most problems in SCI males with 

erectile dysfunction, making the need for penile implants less common. These interventions 

positively affect sexual activity at least in the short-term. Long-term sexual adjustment has 

not been examined.

• Is Viagra® really more benign than intracavernous injections? 

Not really, unless the patient has enough sensation that the injections are 

uncomfortable or if they find that the paraphernalia affects their sexual activity. 

• How does the morbidity of prostaglandin injections compare to the older (less 

expensive) papaverine?

Although the efficacy of these two treatments is similar, priapism and discomfort are 

reported more frequently with papaverine. 

• What is the morbidity of vacuum tumescence devices?

44 
There is a paucity of reports regarding the morbidity of these pumps. These devices 

are not recommended in patients on anticoagulants. Patients must take care to 

remove the device after sexual activity.

• What indications, if any, remain for implantable penile prosthetic devices?

Very few patients will not respond to any of the more benign techniques. Penile 

implants still possess a significant morbidity risk, and in case-series studies, implants 

are often described with condom drainage systems.

45 
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 3. Benevento BT, Sipski ML. Neurogenic bladder, 

neurogenic bowel, and sexual dysfunction in 

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2002;82(6):601-12. 

4. Burns AS, Rivas DA, Ditunno JF. The 

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1986;17(4):283-4. 

143. Renganathan R, Suranjan B, Kurien T. 

Comparison of transdermal nitroglycerin and

intracavernous injection of papaverine in the 

treatment of erectile dysfunction in patients with 

spinal cord lesions. Spinal Cord 1997;35(2):99-

103. 

144. Potter PJ, Hayes KC, Segal JL, Hsieh JT, 

Brunnemann SR, Delaney GA, et al. Randomized

double-blind crossover trial of fampridine-SR 

(sustained release 4-aminopyridine) in patients

with incomplete spinal cord injury. J 

Neurotrauma 1998;15(10):837-49. 

145. Jaworski TM, Richards JS, Lloyd LK. 

Retrospective review of sexual and marital 

satisfaction of spinal cord injury and diabetic

males post penile injection or implant. Urology

1992;40(2):127-31. 

146. Richards JS. Treatment of erectile dysfunction 

secondary to spinal cord injury: Sexual and 

psychosocial impact on couples. Rehabil Psych 

1993;37(3):211-3. 

147. Ohl DA, Wolf LJ, Menge AC, Christman GM, 

Hurd WW, Ansbacher R, et al. Electroejaculation

and assisted reproductive technologies in the 

treatment of anejaculatory infertility. Fertil Steril

2001;76(6):1249-55. 

148. Padron OF, Brackett NL, Weizman MS, Lynne 

CM. Semen of spinal cord injured men freezes

reliably. J Androl 1994;15(3):266-9. 

149. Whipple B, Komisaruk BR. Brain (PET)

responses to vaginal-cervical self-stimulation in 

women with complete spinal cord injury:

preliminary findings. J Sex Marital Ther

2002;28(1):79-86. 

150. Le Chapelain L, Nguyen VT, Dehail P, Berjon JJ, 

Barat M, Mazaux JM, et al. Ejaculatory

stimulation, quality of semen and reproductive 

aspects in spinal cord injured men. Spinal Cord

1998;36(2):132-6. 

151. Bodner DR, Seftel A, Krueger B. Intraurethral 

Alprostsdil (MUSE) for treatment of erectile 

dysfunction in spinal cord injured patients. J 

Spinal Cord Med 1998;21(2):186-7. 

152. van der Aa HE, Hermens H, Alleman E, 

Vorsteveld H. Sacral anterior root stimulation for 

bladder control in patients with a complete lesion 

of the spinal cord. Acta Neurochir (Wien)

1995;134(1-2):88-92. 

153. Giuliano F, Hultling C, El Masry WS, Luchner E, 

Stien R, Maytom MC, et al. Sildenafil citrate

(VIAGRA): a novel oral treatment for erectile

dysfunction caused by traumatic spinal cord 

injury. Int J Clin Pract 1999;Supplement. 102:24-

6. 

154. Hultling C. Partners' perceptions of the efficacy

of sildenafil citrate (VIAGRA) in the treatment of

erectile dysfunction. Int J Clin Pract

1999;Supplement. 102:16-8. 

155. Hultling C, Giuliano F, Quirk F, Pena B, Mishra 

A, Smith MD. Quality of life in patients with

spinal cord injury receiving Viagra (sildenafil

citrate) for the treatment of erectile dysfunction.

Spinal Cord 2000;38(6):363-70. 

53
156. Chancellor MB, Rivas DA, Panzer DE, Freedman 

MK, Staas WE, Jr. Prospective comparison of 

topical minoxidil to vacuum constriction device 

and intracorporeal papaverine injection in

treatment of erectile dysfunction due to spinal

cord injury. Urology 1994;43(3):365-9. 

157. Chapelle PA, Roby-Brami A, Yakovleff A,

Bussel B. Neurological correlations of ejaculation

and testicular size in men with a complete spinal

cord section. J Neurol Neurosurg Psychiatry

1988;51(2):197-202. 

54
List of Excluded Studies 

Fertility

Alici B, Ozkara H, Tunc B, et al. The preferred treatment

options by spinal cord-injured male patients; a prospective 

study. Int J Impot Res 2002;14(Suppl 4):s61. No measure 

of fertility reported. 

Amador MJ. Contemporary information regarding male 

infertility following spinal cord injury. SCI Nurs 

1998;15(3):61-5. No measure of fertility reported. 

Amador MJ. Guide and resources directory to male fertility 

following SCI/D. 17th American association of spinal cord 

injury nurses conference 2000;35-5. No measure of fertility

reported.

Amble JS, Lannoye-Amble R. The winding road of 

infertility: the successful path to parenthood with SCI. 18th 

American association of spinal cord injury nurses

conference 2001;53-4. No measure of fertility reported. 

Amelar RD, Dubin L. Sexual function and fertility in

paraplegic males. Urology 1982;20(1):62-5. No measure of 

fertility reported.

Andres P. Sexual and genital prognosis in adult 

paraplegics. Paraplegia 1972;10(3):218. No measure of

fertility reported.

Atterbury JL, Groome LJ. Pregnancy in women with spinal

cord injuries. [Review] [52 refs]. Crit Care Nurs Clin North

Am 1998;33(4):603-13. No measure of fertility reported.

Auroux M. [Spermatogenesis, the central nervous system 

and paraplegia (author's transl)]. [French]. Journal d 

Urologie et de Nephrologie 1974;80(7-8):621-30. No 

measure of fertility reported.

Bar-Chama N. Assisted reproductive technologies. J Spinal 

Cord Med 2000;23(3):175. No measure of fertility

reported.

Barros A, Sousa M, Andrade MJ, et al. Birth after

electroejaculation coupled to intracytoplasmic sperm 

injection in a gun-shot spinal cord-injured man. Arch 

Androl 1998;41(1):5-9. No measure of fertility reported. 

Beckerman H, Becher J, Lankhorst GJ. The effectiveness 

of vibratory stimulation in anejaculatory men with spinal

cord injury. [Review] [29 refs]. Paraplegia 

1993;31(11):689-99. No measure of fertility reported. 

Benevento BT, Sipski ML. Neurogenic bladder, neurogenic 

bowel, and sexual dysfunction in people with spinal cord 

injury. [Review] [100 refs]. Phys Ther 2002;82(6):601-12. 

No measure of fertility reported. 

Bennett CJ, Seager SW, Vasher EA, et al. Sexual

dysfunction and electroejaculation in men with spinal cord 

injury: review. [Review] [63 refs]. Br J Urol 

1988;139(3):453-7. No measure of fertility reported. 

Beretta G, Zanollo A, Colpi G M, et al. [Vibration

massage in genito-sexual rehabilitation of spinal cord 

injuries. Our experience]. [Italian]. Minerva Urol Nefrol 

1985;37(2):203-6. No pre and post intervention fertility rate 

reported.

Beretta G, Zanollo A, Fanciullacci F, et al., Intracavernous 

injection of papaverine in paraplegic males. Acta Eur Fertil 

1986;17(4):283-4. No measure of fertility reported. 

Berger S. The role of sexual impotence in the concept of 

self in male paraplegics. Zh Nevropatol Psikhiatr Im S S 

Korsakova. No measure of fertility reported.

Biering S, Sonksen J. Sexual function in spinal cord 

lesioned men. Proc Annu Clin Spinal Cord Inj Conf 

2001;39(9):455-70. No measure of fertility reported. 

Biering-Sorensen F, Sonksen J. Sexual function in spinal 

cord lesioned men. Proc Annu Clin Spinal Cord Inj Conf 

2001;39(9):455-70. No measure of fertility reported. 

Bird VG, Brackett NL, Lynne CM, et al. Reflexes and 

somatic responses as predictors of ejaculation by penile 

vibratory stimulation in men with spinal cord injury. Proc

Annu Clin Spinal Cord Inj Conf 2001;39(10):514-9. No pre 

and post intervention fertility rate reported.

Blockmans D, Steeno O. Physostigmine as a treatment for 

anejaculation with paraplegic men. Andrologia 

1988;20(4):311-3. Not an original report of an intervention

trial.

Bodner DR, Seftel AD. Sildenafil in treatment of erectile 

dysfunction in SCI patients. J Spinal Cord Med

2000;23(Suppl 1):46-6. No measure of fertility reported. 

Bodner DR, Seftel A, Krueger B. Intraurethral Alprostsdil 

(MUSE) for treatment of erectile dysfunction in spinal cord 

injured patients. J Spinal Cord Med 1998;21(2):186-7. No 

measure of fertility reported.

Boone TB, Kim ED, Kim YH, et al. Advances in

impotence and fertility technology for neurologically

disabled men. Physical Medicine & Rehabilitation: State of

the Art Reviews 1997;11(1):161-76. No measure of fertility

reported.

 55
Brackett NL. Penile vibratory stimulation for men with 

spinal cord injury. Hum Reprod Update 1999;5(5):551-2. 

No measure of fertility reported. 

Brackett NL. Semen retrieval by penile vibratory

stimulation in men with spinal cord injury. Hum Reprod 

Update 1999;5(3):216-22. No measure of fertility reported.

Brackett NL, Ferrell SM, Aballa TC, et al. An analysis of 

653 trials of penile vibratory stimulation in men with spinal 

cord injury. Br J Urol 1998;159(6):1931-4. No pre and post 

intervention fertility rate reported.

Brackett NL, Nash MS, Lynne CM. Male fertility 

following spinal cord injury: facts and fiction.. Phys Ther 

1996;76(11):1221-31. No measure of fertility reported. 

Brindley GS. Sexual and reproductive problems of 

paraplegic men. Oxf Rev Reprod Biol 1986;8(214):222. No

measure of fertility reported.

Brindley GS. Reflex ejaculation under vibratory

stimulation in paraplegic men. Paraplegia 1981;19(5):299-

302. No measure of fertility reported. 

Brown JF. Patient abuse by partners?. J Spinal Cord Med 

1998;21(conference proceedings). No measure of fertility

reported.

Brown TR. Anejaculation in quadriplegia. [letter;

comment.]. Arch Phys Med Rehabil 1995;76(9):889. No 

measure of fertility reported.

Brown TR, Hensleigh HC, Nagel TC, et al., Anejaculation 

in quadriplegia. Vibratory stimulation for treatment of 

anejaculation in quadriplegic men. Arch Phys Med Rehabil 

1995;76(9):889. No measure of fertility reported. 

Bustillo M, Rajfer J. Pregnancy following insemination

with sperm aspirated directly from vas deferens. Fertil 

Steril 1986;46(1):144-6. No measure of fertility reported.

Byfield G, LaFavor K, Murphy D, et al. Inpatient sexual 

health needs of individuals with acute spinal cord injury. J 

Spinal Cord Med 1999;22(1):13-4. No measure of fertility

reported.

Byfield G, Tymus-Brown T, Laud P, et al. Sexual health 

needs of persons with spinal cord injury six months after

discharge. J Spinal Cord Med 2000;23(Suppl 1):33. No 

measure of fertility reported.

Chapelle PA. [Pregnancy achieved by ambulatory

treatment of an ejaculation in the paraplegic man. Apropos 

of a case]. [French]. Journal d Urologie 1983;89(3):165-8. 

Reported in a language other than English.

Chapelle PA, Colbeau-Justin P, Durand J, et al. 

[Ejaculation problems in traumatic paraplegia]. [French]. 

Sem Hop 1982;58(28-29):1691-7. Reported in a language 

other than English. 

Chapelle PA, Jondet M, Durand J, et al. Pregnancy of the 

wife of a complete paraplegic by homologeous 

insemination after an intrathecal injection of neostigmine.

Paraplegia 1976;14(3):173-7. Not an original report of an 

intervention trial.

Chen D, Hartwig D, Jeyendran RS. Azoospermia - a unique 

challenge in the treatment of infertility in a spinal cord 

injured man. J Spinal Cord Med 2000;23(Suppl 1):43. Not 

an original report of an intervention trial. 

Chen D, Ling EA, Jeyendran RS. Semen extenders to 

salvage ejaculate in a retrograde ejaculate environment: a

potential use in spinal cord-injured men. Arch Phys Med 

Rehabil 1995;76(5):446-9. No pre and post intervention

fertility rate reported. 

Chung PH, Palermo G, Schlegel PN, et al. The use of 

intracytoplasmic sperm injection with electroejaculates

from anejaculatory men. Hum Reprod 1998;13(7):1854-8. 

No measure of fertility reported. 

Chung PH, Verkauf BS, Eichberg RD, et al., 

Electroejaculation and assisted reproductive techniques for 

anejaculatory infertility. Curr Opin Obstet Gynecol 

1996;87(1):22-6. Not an original report of an intervention

trial.

Chung PH, Yeko TR, Mayer JC, et al., Assisted fertility

using electroejaculation in men with spinal cord injury--a 

review of literature. [Review] [56 refs]. Fertil Steril 

1995;64(1):1-9. No measure of fertility reported. 

Clontz D, Kier A, Land D, et al. Effects of sildenafil on 

spinal cord injury patients suffering from erectile

dysfunction. J Spinal Cord Med 1999;22(1):48-9. No 

measure of fertility reported.

Courtois F, Mathieu C, Charvier K. Sexual rehabilitation

for men with spinal cord injury: Preliminary report on a 

behavioral strategy. Sex Disabil 2001;19(2):153-7. No 

measure of fertility reported.

Craven CBC, Mittmann N, Gordon M, et al. The cost utility 

of Viagra for treatment of erectile dysfunction in men after

SCI. J Spinal Cord Med 2002;25(Suppl 1):s44-5. No 

measure of fertility reported.

Craven CBC, Mittmann N, Kaiser A, et al. The "hard truth" 

an information resource for men with SCI and erectile 

dysfunction. J Spinal Cord Med 2002;25( Suppl 1):s44. No 

measure of fertility reported.

Creasey GH. Restoration of bladder, bowel, and sexual 

function. Topics in Spinal Cord Injury Rehabilitation 

1999;5(1):21-32. No measure of fertility reported. 

Cross LL, Meythaler JM, Tuel SM, et al. Pregnancy, labour

and delivery post spinal cord injury. Paraplegia 

1992;30(12):890-902. No fertility intervention reported. 

Denil J, Kuczyk MA, Schultheiss D, et al. Use of assisted

reproductive techniques for treatment of ejaculatory

disorders. Andrologia 1996;28 Suppl 1(43):51. SCI results 

not reported separately. 

56
Denil J, Ohl DA, McGuire EJ, et al. Treatment of 

anejaculation with electroejaculation. Acta Urol Belg 

1992;60(3):15-25. Not an original report of an intervention

trial.

Donatucci CF, Lue TF. Pathophysiology of sexual 

dysfunction in males with physical disabilities. Clin Exp

Hypertens 291-310. No measure of fertility reported. 

Donohue J, Gebhard P. The Kinsey Institute/Indiana 

University report on sexuality and spinal cord injury. Sex

Disabil 1995;13(1):7-85. No measure of fertility reported.

Drench M E. Impact of altered sexuality and sexual 

function in spinal cord injury: A review: Sex Disabil 

1992;10(1):11-14. No measure of fertility reported. 

Ekland MB, Rines BA. Women's experience of sexual 

adjustment post spinal cord injury. J Spinal Cord Med 

2002;25(Suppl1):s44. No measure of fertility reported. 

Ekland M, Griffin S, Copeland J, et al. Exploring male 

fertility options after spinal cord injury: the role of the

nurse clinician. [Review] [7 refs]. SCI Nurs 1998;15(4):95-

8. No measure of fertility reported. 

Elliot S, Szasz G, Zouves C. The combined use of

vibrostimulation and in vitro fertilization: successful 

pregnancy outcome from a retrograde specimen obtained

from a spinal cord-injured male. J In Vitro Fert Embryo

Transf 1991;8(6):348-52. No measure of fertility reported.

Elliott S. Anejaculation, fertility and sex. Can J Hum Sex 

1996;2(3):124-7. No measure of fertility reported. 

Elliott SP, Orejuela F, Hirsch IH, et al. Testis biopsy

findings in the spinal cord injured patient. Br J Urol 

2000;163(3):792-5. No fertility intervention reported. 

Fernandez JB, Barber DB, Able AC, et al. Acute spinal 

cord injury in pregnancy: cases and literature review. J 

Spinal Cord Med 2000;23(3):182. No measure of fertility

reported.

Fiedler K, Lochner-Ernst D, Krusmann G, et al. Two 

pregnancies after in-vitro fertilization with spermatozoa 

from alloplastic spermatocoeles. Hum Reprod 

1993;8(3):422-4. No measure of fertility reported. 

Fisher T, Byfield G, Tymus T, et al. The profile of sexual 

health needs of individuals one year after spinal cord 

injury. J Spinal Cord Med 2001;24(Suppl 1):s35. No 

measure of fertility reported.

Francois M, Maury M, Jouannet P, et al. [Our experience 

with electro-ejaculation in paraplegics. First pregnancies]. 

[French]. Journal d Urologie et de Nephrologie 1979;85(7-

8):513-24. Reported in a language other than English. 

Francois N. [Genital sexual and procreation disorders in 

patients with spinal cord injuries]. [French]. Rev Prat 

1995;45(16):2017-21. Reported in a language other than 

English. 

Francois N, Maury M. Sexual aspects in paraplegic

patients. Paraplegia 1987;25(3):289-92. No measure of

fertility reported.

Francois N, Jouannet P, Maury M. [Genitosexual function 

of paraplegics]. [French]. Journal d Urologie 

1983;89(3):159-64. Reported in a language other than

English. 

Francois N, Maury M, David G, et al. [Electric stimulation 

of ejaculation in paraplegia. Possibilities of impregnation

using artificial insemination]. [French]. Acta Urol Belg

1979;47(1):173-86. Reported in a language other than

English. 

Goddard LR. Sexuality and spinal cord injury. J Neurosci 

Nurs 1988;20(4):240-4. No measure of fertility reported. 

Green BG, Killorin EW, Bennett JK, et al. Erectile 

response following administration of sildenafil citrate 

(Viagra) in the neuropathic patient:initial results. J Spinal 

Cord Med 1999;22(1):48. No measure of fertility reported.

Green B, Killorin E W, Rozas K, et al. Results of elective 

electroejaculation with freezing and subsequent sperm 

manipulation versus electroejaculation at ovulation to 

achieve pregnancy in male factor spinal cord injured males.

J Spinal Cord Med 2000;23(Suppl 1):45. No measure of 

fertility reported.

Grundy D, Russell J. ABC of spinal cord injury. Later 

management and complications--I. Br Med J (Clin Res Ed) 

1986;292(6521):677-80. No measure of fertility reported.

Halstead L S, Seager SWJ. Fertility aspects of men with 

spinal cord injury: results obtained by electroejaculation.

Arch Phys Med Rehabil 1999;80:1119. SCI results not 

reported separately. 

Hazama M, Nakano M, Shinozaki M, et al. [A case of a 

complete paraplegic fathering a girl following artificial

insemination after an intrathecal neostigmine injection]. 

[Review] [12 refs] [Japanese]. Hinyokika Kiyo - Acta 

Urologica Japonica 1988;34(6):1047-50. Reported in a 

language other than English. 

Higgins GE. Sexual response in spinal cord injured adults: 

a review of the literature. Arch Sex Behav 1979;8( 2):173-

96. No measure of fertility reported. 

Hirsch IH, Jeyendran RS, Sedor J, et al. Biochemical 

analysis of electroejaculates in spinal cord injured men: 

comparison to normal ejaculates. Br J Urol 1991;145(1):73-

6. No pre and post intervention fertility rate reported. 

Hirsch IH, Kulp-Hugues D, Sedor J, et al. Simplified and 

objective assessment of spermatogenesis in spinal cord 

injured men by flow cytometry analysis. Paraplegia 

1993;31(12):785-92. No measure of fertility reported. 

Hirsch IH, Seager SW, Sedor J, et al. Electroejaculatory

stimulation of a quadriplegic man resulting in pregnancy.

57
Arch Phys Med Rehabil 1990;71(1):54-7. No measure of

fertility reported.

Hirsch IH, Sedor J, Callahan HJ, et al. Systemic sperm

autoimmunity in spinal-cord injured men. Arch Androl 

1990;25(1):69-73. No fertility intervention reported. 

Hirsh AV, Mills C, Tan SL, et al. Pregnancy using 

spermatozoa aspirated from the vas deferens in a patient

with ejaculatory failure due to spinal injury. Hum Reprod 

1993;8(1):89-90. No measure of fertility reported. 

Holstein AF, Sauerwein D, Schirren U. [Spermatogenesis 

in patients with traumatic transverse paralysis]. [German]. 

Rev Med Interna Neurol Psihiatr Neurochir 

Dermatovenerol Med Interna 1985;24(4):208-15. Reported

in a language other than English. 

Hovatta O, von Smitten K. Sperm aspiration from vas 

deferens and in-vitro fertilization in cases of non-treatable 

anejaculation. Hum Reprod 1993;8(10):1689-91. SCI 

results not reported separately. 

Hudson BS. Erectile dysfunction options for SCI males. 

17th American association of spinal cord injury nurses

conference 2000;34. No measure of fertility reported. 

Jackson AB. Pregnancy and delivery. for women with 

disabilities. Sex Disabil 1996;14(3):211-9. Not an original 

report of an intervention trial. 

Jackson RW. Sexual rehabilitation after cord injury.

Paraplegia 1972;10(1):50-5. No measure of fertility

reported.

Jondet M, Got CL, Chapelle PA, et al. [Full term pregnancy 

in the wife of a total paraplegic following intrathecal 

injection of neostigmine and artificial insemination]

[letter]. [French]. Nouv Presse Med 1976;5(35):2325. 

Reported in a language other than English.

Jouannet P, Francois N, Maury M. [Evaluation of fertility

in paraplegic men]. [French]. Journal d Urologie 

1983;89(3):169-71. Reported in a language other than

English. 

Keeshin S, Lane G, Kanter S, et al. Medical and

psychosocial issues in women with spinal cord injury: a 

comprehensive survey. Arch Phys Med Rehabil 

1999;80:1119. No measure of fertility reported. 

Key BH, Hale AM, Jackson AB. Promoting accessible 

health care examinations for women with SCI. 15th 

American association of spinal cord injury nurses

conference 1998;43. No measure of fertility reported. 

Kier AJ, Kennelly MJ, Holdren RE, et al. Sildenafil effects

on spinal cord patients with erectile dysfunction. 16th 

American association of spinal cord injury nurses

conference 1999;32-33. No measure of fertility reported. 

Kimura Y. [Sexual function of the paraplegics; with a

special reference to erection and ejaculation]. [Japanese]. 

Nippon Hinyokika Gakkai Zasshi 1970;61(10):1010-6. 

Reported in a language other than English.

Kolon TF, Philips KA, Buch JP. Pentoxifylline 

enhancement of post-thaw motility in cryopreserved semen 

of spinal cord-injured men. Int J Fertil Menopausal Stud

1995;40(3):156-60. No pre and post intervention fertility

rate reported. 

Laschke S, Carl S, Staehler G, et al. Efficacy and 

reproducibility of sildenafil (Viagra) in erectile dysfunction 

in spinal cord injured men. J Spinal Cord Med 

2002;25(Suppl1):s43. No measure of fertility reported. 

Leduc BE, Poulin O, Parisi D. [Pregnancy by insemination 

from a quadriplegic donor after stimulation by

physostigmine]. [French]. CMAJ (Canadian Medical

Association Journal) 1988;139(11):1071-2. Reported in a 

language other than English. 

Leeton J, Yates C, Rawicki B. Successful pregnancy using 

known donor oocytes fertilized in vitro by spermatozoa 

obtained by electro-ejaculation from a quadriplegic 

husband. Hum Reprod 1991;6(3):384-5. No measure of

fertility reported.

Leriche A, Berard E, Vauzelle JL, et al. Histological and

hormonal testicular changes in spinal cord patients. 

Paraplegia 1977;15(3):274-9. No measure of fertility

reported.

Lewis JH. What's new in the treatment of erectile 

dysfunction. 15th American association of spinal cord 

injury nurses conference 1998;21. No measure of fertility

reported.

Linsenmeyer TA. Male infertility following spinal cord 

injury. [Review] [48 refs]. J Am Paraplegia Soc 

1991;14(3):116-21. No measure of fertility reported. 

Linsenmeyer TA. Sexual function and infertility following 

spinal cord injury. [Review] [52 refs]. Phys Med Rehabil 

Clin N Am 2000;11(1):141-56. No measure of fertility

reported.

Linsenmeyer TA. Management of male infertility. Vet J Ed

487-509. No measure of fertility reported.

Linsenmeyer TA. Overview of male infertility following 

SCI. J Spinal Cord Med 2000;23(3):174. No measure of

fertility reported.

Linsenmeyer TA, Perkash I. Infertility in men with spinal 

cord injury. [Review] [75 refs]. Arch Phys Med Rehabil 

1991;72(10):747-54. No measure of fertility reported. 

58
Linsenmeyer TA, Perkash I. Infertility in men with spinal 

cord injury. Arch Phys Med Rehabil 1991;72(10):747-54. 

No measure of fertility reported. 

Linsenmeyer T, Ottenweller J, Anesetti R. Effects of 

Vitamin E/Selenium on sperm motility following SCI. J 

Spinal Cord Med 1998;21(2):164. No measure of fertility

reported.

Linsenmeyer T, Wilmot C, Anderson RU. The effects of

the electroejaculation procedure on sperm motility.

Paraplegia 1989;27(6):465-9. No pre and post intervention

fertility rate reported. 

Loughead RM. Males' perception of changes in their sex

role orientation as a function of spinal cord injury. Bull

Acad Natl Chir Dent. No measure of fertility reported. 

Lynne CM, Aballa TC, Wang TJ, et al. Serum and semen 

prostate specific antigen concentrations are different in

young spinal cord injured men compared to normal 

controls. Br J Urol 1999;162(1):89-91. No fertility 

intervention reported. 

Macourt D, Engel S, Jones RF, et al. Pregnancy by gamete 

intrafallopian transfer (GIFT) with sperm aspirated from

the vaso-epididymal junction of spinal injured man: case 

report. Paraplegia 1991;29(8):550-3. No measure of 

fertility reported.

Marina S, Marina F, Alcolea R, et al. Triplet pregnancy

achieved through intracytoplasmic sperm injection with 

spermatozoa obtained by prostatic massage of a paraplegic 

patient: case report. Hum Reprod 1999;14(6):1546-8. No 

measure of fertility reported.

Martin MM. Fertility in SCI males. SCI Nurs 1992;9(1):36-

8. No measure of fertility reported. 

Mauney MC. Fertility program/electroejaculationcoordination of services. 17th American association of 

spinal cord injury nurses conference 2000;34-35. No 

measure of fertility reported.

McBride KE, Rines B. Sexuality and SCI: a roadmap for 

nurses. 15th American association of spinal cord injury

nurses conference 1998;19. No measure of fertility

reported.

McKenna KE. Neural circuitry involved in sexual function.

[Review] [78 refs]. J Spinal Cord Med 2001;24(3):148-54. 

No measure of fertility reported. 

Mendius RA. Female sexuality and spinal cord injury. SCI 

Nurs 1989;6(4):68-74. No measure of fertility reported. 

Momose H, Hirao Y, Yamamoto M, et al. 

Electroejaculation in patients with spinal cord injury: first 

report of a large-scale experience from Japan. Int J Urol 

1995;2(5):326-9. No pre and post intervention fertility rate

reported.

Monga M, Bernie J, Rajasekaran M. Male infertility and

erectile dysfunction in spinal cord injury: a review. Arch 

Physical Med Rehabil 1999;80(10):1331-9. No measure of

fertility reported.

Murphy DF. Sexual health information sheets. 15th 

American association of spinal cord injury nurses

conference 1998;37-8. No measure of fertility reported. 

Nagai S, Kasai T, Ogawa K, et al. Successful treatment of

infertility due to anejaculation with in vitro fertilization and

embryo transfer: a report of two cases. Tohoku J Exp Med 

1998;184(3):241-6. Not an original report of an 

intervention trial.

Otani T, Kai S, Narushima M. Ejaculation obtained by

intracavernous papaverine in a cervical spinal cord injury

patient resulting in pregnancy and childbirth. Case report.

Paraplegia 1994;32(3):180-1. No measure of fertility

reported.

Otani T, Kondo A, Takita T. A paraplegic fathering a child

after an intrathecal injection of neostigmine: case report.

Paraplegia 1986;24(1):32-7. No measure of fertility

reported.

Perkash I, Martin DE, Warner H. Reproductive problems of 

paraplegics and the present status of electroejaculation.

Cent Nerv Syst Trauma 1986;3(1):13-23. No measure of

fertility reported.

Perkash I, Martin DE, Warner H, et al. Electroejaculation 

in spinal cord injury patients: simplified new equipment 

and technique. Br J Urol 1990;143(2):305-7. No pre and

post intervention fertility rate reported. 

Piera JB. The establishment of a prognosis for genitosexual function in the paraplegic and tetraplegic male. 

Paraplegia 1973;10(4):271-8. Not an original report of an 

intervention trial.

Porter-Gaskins J. In search of baby. Accent on Living 

1996;41(3):50-52. No measure of fertility reported. 

Powers J, Meats J, Saylor L, et al. Care of a pregnant spinal 

cord injured patient. 17th American association of spinal

cord injury nurses conference 2000;40. No measure of

fertility reported.

Rajasekaran M, Monga M. Cellular and molecular causes

of male infertility in spinal cord injury. [Review] [52 refs].

J Androl 1999;20(3):326-30. No measure of fertility

reported.

Raviv G, Heruti RJ, Shaked A, et al. Sexual rehabilitation:

clinical experience with sildenafil citrate (Viagra) in spinal 

cord injured patients. Int J Impot Res 2000;12(Suppl 5):s1. 

No measure of fertility reported. 

Rawicki H, Lording DW. Assisted fertility in complete

paraplegia: case report. Paraplegia 1988;26(6):401-4. Not 

an original report of an intervention trial. 

59
Raymond CA. New use for old method of inducing 

ejaculation may give hope of fatherhood to some spinal 

cord-injured men. JAMA 1987;258(6):743-4. Not an 

original report of an intervention trial. 

Romeo AJ. Sexual adjustment to spinal-cord injury. No 

measure of fertility reported.

Rucker B, Szasz G, Carpenter C. Legal, ethical and 

religious issues related to fertility enhancement of men with

spinal cord injuries. Can J Rehabil 1988;1(4):225-31. No 

measure of fertility reported.

Rutkowski SB, Geraghty TJ, Hagen DL, et al. A 

comprehensive approach to the management of male 

infertility following spinal cord injury. Proc Annu Clin

Spinal Cord Inj Conf 1999;37(7):508-14. No measure of 

fertility reported.

Sadowsky CL. Electrical stimulation in spinal cord injury.

NeuroRehabilitation 2001;16(3):165-9. No measure of

fertility reported.

Schatte EC, Orejuela FJ, Lipshultz LI, et al. Treatment of 

infertility due to anejaculation in the male with

electroejaculation and intracytoplasmic sperm injection. Br

J Urol 2000;163( 6):1717-20. SCI results not reported 

separately.

Scheutzow MH, Bockenek WL. Electroejaculation in 

persons with spinal cord injury: a unique complication and

review of the literature. Arch Phys Med Rehabil 

1998;79:1187. No measure of fertility reported. 

Seager SW, Halstead LS. Fertility options and success after 

spinal cord injury. [Review] [32 refs]. Urol Clin North Am

1993;20(3):543-8. No measure of fertility reported. 

Sedor JF, Hirsch IH. Evaluation of sperm morphology of 

electroejaculates of spinal cord-injured men by strict

criteria. Fertil Steril 1995;63(5):1125-7. No pre and post 

intervention fertility rate reported.

Seftel AD, Bodner DR, Gothe B, et al. Efficacy of

sildenafil in spinal cord injured men. J Spinal Cord Med 

2000;23(3):207. No measure of fertility reported. 

Shaban SF, Seager SW, Lipshultz LI. Clinical 

electroejaculation. [Review] [31 refs]. Med Instrum 

1988;22(2):77-81. No measure of fertility reported. 

Shenot PJ, Rajan R, Rivas DA. Initial experience with 

sildenafil (viagra) in spinal cord injured men with erectile 

dysfunction. J Spinal Cord Med 1999;22(1):49. No 

measure of fertility reported.

Siosteen A. Emission dysfunctions and current modes of 

treatment in neurogenic male infertility. Scand J Urol 

Nephrol 1988;Supplementum. 110(59):64. No measure of

fertility reported.

Sipski ML. Spinal cord injury and sexual function: An 

educational model. Vet J Ed 149-176. No measure of 

fertility reported.

Sipski ML, Katz MA, Blight AR. The effects of oral 

fampridine-SR (sustained-release 4-aminopyridine) on 

sexual function in subjects with chronic motor-incomplete 

spinal cord injury. J Spinal Cord Med 2003;26(Suppl 

1):s18. No measure of fertility reported. 

Sonksen J, Biering-Sorensen F. Semen quality in the same 

man before and after spinal cord injury. Case report. 

Paraplegia 1994;32(2):117-9. No measure of fertility

reported.

Sonksen J, Biering-Sorensen F. Fertility in men with spinal

cord or cauda equina lesions. [Review] [85 refs]. Semin 

Neurol 1992;12(2):106-14. No measure of fertility

reported.

Sonksen JO, Biering-Sorensen F, Kristensen JK, et al. 

[Ejaculation induced by electrostimulation in men with 

spinal cord injuries]. [Danish]. Ugeskr Laeger

1993;155(3):176-9. Reported in a language other than 

English. 

Sonksen J, Ohl DA, Momose H, et al. Treatment of 

infertility. [see comments.]. [Review] [46 refs]. Proc Annu 

Clin Spinal Cord Inj Conf 1999;37(2):89-95. Not an 

original report of an intervention trial. 

Sprouse DO. Electroejaculation for anejaculate males. Urol 

Nurs 1994;14(2):57-61. No measure of fertility reported. 

Sprouse DO. Fertility issues and anejaculation. Urol Nurs

1994;14(2):62-5. No measure of fertility reported. 

Staerman F, Bryckaert PE, Youinou Y, et al. 

[Pharmacologic stimulation of ejaculation with midodrine 

hydrochloride (Gutron) for medically assisted reproduction

in spinal injury]. [French]. Prog Urol 2001;11(6):1264-8. 

Reported in a language other than English.

Stien R. Spinal cord injured men and infertility. [letter;

comment.]. Proc Annu Clin Spinal Cord Inj Conf

1999;37(7):527. No measure of fertility reported. 

Stien R. Sexual dysfunctions in the spinal cord injured. 

Paraplegia 1992;30(1):54-7. No measure of fertility

reported.

Szasz G, Carpenter C. Clinical observations in vibratory 

stimulation of the penis of men with spinal cord injury.

Arch Sex Behav 1989;18(6):461-74. No pre and post 

intervention fertility rate reported.

Takeda H, Otani T, Ito Y. Efficacy of sildenafil citrate for

ED associated with spinal cord injury. Int J Impot Res 

2000;12(Suppl 2):s19. No measure of fertility reported. 

Tallada M, Ruiz F, Herruzo A, et al. [Intrathecal injection 

of neostigmine in a paraplegia patient, in order to obtain

60
semen for artifical insemination]. [Spanish]. Actas Urol 

Esp 1977;1(6):347-50. Reported in a language other than 

English. 

Tarabulcy E. Sexual function in the normal and in

paraplegia. Paraplegia 1972;10(3):201-8. No measure of 

fertility reported.

Tepper MS. Providing comprehensive sexual health care in

SCI rehabilitation. 15th American association of spinal

cord injury nurses conference 1998;26. No measure of

fertility reported.

Thomas AJ. Ejaculatory dysfunction. Fertil Steril 

1983;39(4):445-54. No measure of fertility reported. 

Thomas RJ, McLeish G, McDonald IA. Electroejaculation

of the paraplegic male followed by pregnancy. Med J Aust 

1975;2(21):789. Not an original report of an intervention

trial.

Tollon C, Soulie M, Pontonnier F, et al. [Prevention of 

sterility in spinal cord injured men]. [French]. Prog Urol 

1997;7(2):203-8. No measure of fertility reported. 

Truss MC, Djamilian MH, Tan HK, et al. Single potential

analysis of cavernous electrical activity. Four years'

experience in more than 500 patients with erectile 

dysfunction. Eur Urol 1993;24:358-65. No measure of

fertility reported.

Urey Jon R. Marital adjustment following spinal cord 

injury: An analysis of recreational, sexual and conflict

resolution behaviours. ADM No measure of fertility

reported.

Veit N, Mikelonis M. Health Issues of women who have 

spinal cord impairment. 18th American association of 

spinal cord injury nurses conference 2001;25. No measure 

of fertility reported. 

Velasco M, Buyo A, Barrera S, et al. Sexual and 

gynecologic issues in a sample of women with spinal cord 

injury. J Spinal Cord Med 2002;25(Suppl 1):s45. No 

fertility intervention reported.

Ver Voort SM. Infertility in spinal-cord injured male. 

Urology 1987;29(2):157-65. No measure of fertility

reported.

Verduyn WH. Spinal cord injured women, pregnancy and 

delivery. Paraplegia 1986;24(4):231-40. No measure of

fertility reported.

Villeneuve MJ. Sexual function and fertility: the impact of

spinal cord injury. CONA Journal 1989;11(1):12-7. No 

measure of fertility reported.

Wagenknecht LV. Alloplastic spermatocele: 20 years 

experience and perspectives. Acta Chir Hung 1994;34(3-

4):207-9. No measure of fertility reported.

Walbroehl GS. Impaired spermatogenesis. Am Fam 

Physician 1987;36(5):45. No measure of fertility reported.

Waldbaum J, Chen D, Nussbaum SB, et al. Use of

transurethral alprostadil to treat erectile dysfunction in 

spinal cord injured patients. Arch Phys Med Rehabil 

1998;79:1184. No measure of fertility reported. 

Wang YH, Huang TS, Lien IN. Hormone changes in men 

with spinal cord injuries. Am J Phys Med Rehabil 

1992;71(6):328-32. No fertility intervention reported. 

Wang YH, Huang TS, Lin MC, et al. Scrotal temperature in

spinal cord injury. Am J Phys Med Rehabil 1993;72(1):6-9. 

No measure of fertility reported. 

Weinberg JS. Human Sexuality and spinal cord injury. Crit 

Care Nurs Clin North Am 1982;17(3):407-19. No measure 

of fertility reported. 

Winston A, Hirschenfang S, Fine L, et al. Patterns of 

psychological decompensation in patients with spinal cord 

syndromes. Dis Nerv Syst 1969;30(12):824-7. No measure 

of fertility reported. 

Wolski JK, Kluge P, Koziol K, et al. [Needle testicular

biopsy in the diagnosis of male infertility]. [Polish]. 

Ginekol Pol 1998;69(6):541-4. Not an original report of an 

intervention trial.

Yamamoto M, Momose H, Yamada K. Fathering of a child

with the assistance of electroejaculation in conjunction with 

intracytoplasmic sperm injection: case report. Proc Annu 

Clin Spinal Cord Inj Conf 1997;35(3):179-80. No measure 

of fertility reported. 

Yamamoto M, Yamada K, Hirata N, et al.

[Electroejaculation and assisted reproductive techniques in

the patients with spinal cord injury]. [Japanese]. Nippon 

Hinyokika Gakkai Zasshi 1997;88(3):420-6. Reported in a 

language other than English. 

Yarkony GM. Enhancement of sexual function and fertility

in spinal cord-injured males. Am J Phys Med Rehabil 

1990;69(2):81-7. No measure of fertility reported. 

Yarkony GM, Chen D. Sexuality in patients with spinal 

cord injury. Physical Medicine & Rehabilitation: State of

the Art Reviews 1995;9(2):325-44. No measure of fertility

reported.

Zeller FL, Lassalle G, Repetti P, et al. Electromyographical 

findings in patients with spinal cord injury and erectile

dysfunction. Int J Impot Res 2001;13(Suppl 2):s16. No 

measure of fertility reported.

61
Sexual Dysfunction

Alici B, Ozkara H, Tunc B, et al. The preferred treatment

options by spinal cord-injured male patients;a prospective 

study. Int J Impot Res 2002;14(Suppl 4):s61. No measure 

of sexual dysfunction reported. 

Amador MJ. Contemporary information regarding male 

infertility following spinal cord injury. SCI Nurs 

1998;15(3):61-5. No measure of sexual dysfunction 

reported.

Amador MJ. Guide and resources directory to male fertility 

following SCI/D. 17th American association of spinal cord 

injury nurses conference 2000;35-5. No measure of sexual 

dysfunction reported. 

Amble JS, Lannoye-Amble R. The winding road of 

infertility: the successful path to parenthood with SCI. 18th 

American association of spinal cord injury nurses

conference 2001;53-4. No measure of sexual dysfunction

reported.

Amelar RD, Dubin L. Sexual function and fertility in

paraplegic males. Urology 1982;20(1):62-5. No measure of 

sexual dysfunction reported. 

Andres P. Sexual and genital prognosis in adult 

paraplegics. Paraplegia 1972;10(3):218. No measure of

sexual dysfunction reported. 

Auroux M. [Spermatogenesis, the central nervous system 

and paraplegia (author's transl)]. [French]. Journal d 

Urologie et de Nephrologie 1974;80(7-8):621-30. No 

measure of sexual dysfunction reported. 

Bar-Chama N. Assisted reproductive technologies. J Spinal 

Cord Med 2000;23(3):175. No measure of sexual 

dysfunction reported. 

Beckerman H, Becher J, Lankhorst GJ. The effectiveness 

of vibratory stimulation in anejaculatory men with spinal

cord injury. Review article. [Review] [29 refs]. Paraplegia

1993;31(11):689-99. No measure of sexual dysfunction

reported.

Benevento BT, Sipski ML. Neurogenic bladder, neurogenic 

bowel, and sexual dysfunction in people with spinal cord 

injury. [Review] [100 refs]. Phys Ther 2002;82(6):601-12. 

No measure of sexual dysfunction reported. 

Bennett CJ, Seager SW, Vasher EA, et al. Sexual

dysfunction and electroejaculation in men with spinal cord 

injury: review. [Review] [63 refs]. Br J Urol 

1988;139(3):453-57. No measure of sexual dysfunction

reported.

Bensman A, Kottke FJ. Induced emission of sperm utilizing 

electrical stimulation of the seminal vesicles and vas

deferens. Arch Phy Med Rehab 1966;47(7):436-43. No 

measure of sexual dysfunction reported. 

Beretta G, Chelo E, Zanollo A. Reproductive aspects in

spinal cord injured males. Paraplegia 1989;27(2):113-8. No 

measure of sexual dysfunction reported. 

Beretta G, Zanollo A, Chelo E, et al., Seminal parameters

and auto-immunity in paraplegic/quadraplegic men. Acta

Eur Fertil 1987;18(3):203-5. No measure of sexual 

dysfunction reported. 

Beretta G, Zanollo A, Colpi GM, et al. [Vibration massage 

in genito-sexual rehabilitation of spinal cord injuries. Our

experience]. [Italian]. Minerva Urol Nefrol 

1985;37(2):203-6. Reported in a language other than 

English. 

Berger S. The role of sexual impotence in the concept of 

self in male paraplegics. Zh Nevropatol Psikhiatr Im S S 

Korsakova Concept No sexual dysfunction intervention 

reported.

Biering S, Sonksen J. Sexual function in spinal cord 

lesioned men. Proc Annu Clin Spinal Cord Inj Conf 

2001;39(9):455-70. No measure of sexual dysfunction

reported.

Biering-Sorensen F, Sonksen J. Penile erection in men with

spinal cord or cauda equina lesions. [Review] [76 refs].

Semin Neurol 1992;12(2):98-105. No measure of sexual 

dysfunction reported. 

Biering-Sorensen F, Sonksen J. Sexual function in spinal 

cord lesioned men. Proc Annu Clin Spinal Cord Inj Conf 

2001;39(9):455-70. No measure of sexual dysfunction

reported.

Bird VG, Brackett NL, Lynne CM, et al. Reflexes and 

somatic responses as predictors of ejaculation by penile 

vibratory stimulation in men with spinal cord injury. Proc

Annu Clin Spinal Cord Inj Conf 2001;39(10):514-19. No 

sexual dysfunction intervention reported.

Bodner DR, Seftel AD. Sildenafil in treatment of erectile 

dysfunction in SCI patients. J Spinal Cord Med

2000;23(Suppl 1):46. No measure of sexual dysfunction

reported.

Bodner D R, Lindan R, Leffler E, et al. The application of 

intracavernous injection of vasoactive medications for 

erection in men with spinal cord injury. Br J Urol

1987;138(2):310-11. No measure of sexual dysfunction

reported.

Boone TB, Kim ED, Kim YH, et al. Advances in

impotence and fertility technology for neurologically

disabled men. Physical Medicine & Rehabilitation: State of

the Art Reviews 1997;11(1):161-76. No measure of sexual 

dysfunction reported. 

 62
63

Boyce EG, Umland EM. Sildenafil citrate: a therapeutic 

update. Clin Ther 2001;23(1):2-23. No measure of sexual 

dysfunction reported. 

Brackett NL. Semen retrieval by penile vibratory 

stimulation in men with spinal cord injury. Hum Reprod 

Update 1999;5(3):216-22. No measure of sexual 

dysfunction reported. 

Brackett NL, Abae M, Padron OF, et al. Treatment by 

assisted conception of severe male factor infertility due to 

spinal cord injury or other neurologic impairment. Journal 

of Assisted Reproduction & Genetics 1995;12(3):210-6. No 

measure of sexual dysfunction reported. 

Brackett NL, Davi RC, Padron OF, et al. Seminal plasma of 

spinal cord injured men inhibits sperm motility of normal 

men. Br J Urol 1996;155(5):1632-5. No measure of sexual 

dysfunction reported. 

Brackett NL, Ferrell SM, Aballa TC, et al. An analysis of 

653 trials of penile vibratory stimulation in men with spinal 

cord injury. Br J Urol 1998;159(6):1931-4. No measure of 

sexual dysfunction reported. 

Brackett NL, Lynne CM, Aballa TC, et al. Sperm motility 

from the vas deferens of spinal cord injured men is higher 

than from the ejaculate. Br J Urol 2000;164(3 Pt 1):712-

715. No measure of sexual dysfunction reported. 

Brackett NL, Lynne CM, Weizman MS, et al. Endocrine 

profiles and semen quality of spinal cord injured men. Br J 

Urol 1994;151(1):114-9. No sexual dysfunction 

intervention reported. 

Brackett NL, Lynne CM, Weizman MS, et al. Scrotal and 

oral temperatures are not related to semen quality of serum 

gonadotropin levels in spinal cord-injured men. J Androl 

1994;15(6):614-9. No measure of sexual dysfunction 

reported. 

Brackett NL, Nash MS, Lynne CM. Male fertility 

following spinal cord injury: facts and fiction. Phys Ther 

1996;76(11):1221-31. No measure of sexual dysfunction 

reported. 

Brackett NL, Padron OF, Lynne CM. Semen quality of 

spinal cord injured men is better when obtained by 

vibratory stimulation versus electroejaculation. Br J Urol 

1997;157(1):151-7. No measure of sexual dysfunction 

reported. 

Brackett NL, Santa-Cruz C, Lynne CM. Sperm from spinal 

cord injured men lose motility faster than sperm from 

normal men: the effect is exacerbated at body compared to 

room temperature. Br J Urol 1997;157(6):2150-3. No 

measure of sexual dysfunction reported. 

Brindley GS. Electroejaculation and the fertility of 

paraplegic men. Sexuality & Disability 1981;3(3):225-229. 

No measure of sexual dysfunction reported. 

Brindley GS. Electroejaculation: its technique, neurological 

implications and uses. J Neurol Neurosurg Psych 

1981;44(1):9-18. No measure of sexual dysfunction 

reported. 

Brindley GS. Reflex ejaculation under vibratory 

stimulation in paraplegic men. Paraplegia 1981;19(5):299-

302. No measure of sexual dysfunction reported. 

Brindley GS. The fertility of men with spinal injuries. 

Paraplegia 1984;22(6):337-48. No measure of sexual 

dysfunction reported. 

Brindley GS. Sexual and reproductive problems of 

paraplegic men. Oxf Rev Reprod Biol. 1986;8:214-22. No 

measure of sexual dysfunction reported. 

Brindley GS. The Ferrier lecture, 1986. The actions of 

parasympathetic and sympathetic nerves in human 

micturition, erection and seminal emission, and their 

restoration in paraplegic patients by implanted electrical 

stimulators. Proc R Soc Lond B Biol Sci 

1988;235(1279):111-20. No measure of sexual dysfunction 

reported. 

Brindley GS, Scott GI, Hendry WF. Vas cannulation with 

implanted sperm reservoirs for obstructive azoospermia or 

ejaculatory failure. Br J Urol 1986;58(6):721-3. No 

measure of sexual dysfunction reported. 

Brinsden PR, Avery SM, Marcus S, et al. Transrectal 

electroejaculation combined with in-vitro fertilization: 

effective treatment of anejaculatory infertility due to spinal 

cord injury. Hum Reprod 1997;12(12):2687-92. No 

measure of sexual dysfunction reported. 

Brown JF. Patient abuse by partners?. J Spinal Cord Med 

1998;21(conference proceedings). No measure of sexual 

dysfunction reported. 

Buch JP, Zorn BH. Evaluation and treatment of infertility 

in spinal cord injured men through rectal probe 

electroejaculation. Br J Urol 1993;149(5 Pt 2):1350-4. No 

measure of sexual dysfunction reported. 

Burks JS. Rehabilitation of multiple sclerosis patients with 

spinal cord dysfunction compared to spinal cord injury 

patients. J Neurol Rehabil 1994;8(1):17-24. No measure of 

sexual dysfunction reported. 

Burns AS, Jackson AB. Gynecologic and reproductive 

issues in women with spinal cord injury. Phys Med Rehabil 

Clin N Am. 2001;12(1):183-99. No measure of sexual 

dysfunction reported. 

Burns AS, Rivas DA, Ditunno JF. The management of 

neurogenic bladder and sexual dysfunction after spinal cord 

injury. [Review] [82 refs]. Spine. 2001;26(24 Suppl):S129-

36. No measure of sexual dysfunction reported. 
64

Bustillo M, Rajfer J. Pregnancy following insemination 

with sperm aspirated directly from vas deferens. Fertil 

Steril 1986;46(1):144-6. No measure of sexual dysfunction 

reported. 

Byfield G, LaFavor K, Murphy D, et al. Inpatient sexual 

health needs of individuals with acute spinal cord injury. J 

Spinal Cord Med 1999;22(1):13-4. No measure of sexual 

dysfunction reported. 

Byfield G, Tymus-Brown T, Laud P, et al. Sexual health 

needs of persons with spinal cord injury six months after 

discharge. J Spinal Cord Med 2000;23(Suppl 1):33. No 

measure of sexual dysfunction reported. 

Chalouhy E, Armache K, Kassardjian Z, et al. 

[Implantation of the Ultrex type inflatable penile prosthesis. 

Four years experience]. [French]. Journal Medical Libanais 

- Lebanese Medical Journal 1996;44(2):60-2. Reported in a 

language other than English. 

Chapelle PA. [Pregnancy achieved by ambulatory 

treatment of an ejaculation in the paraplegic man. Apropos 

of a case]. [French]. J Urol (Paris) 1983;89(3):165-8. No 

measure of sexual dysfunction reported. 

Chapelle PA, Blanquart F, Puech AJ, et al. Treatment of 

anejaculation in the total paraplegic by subcutaneous 

injection of Physostigmine. Paraplegia 1983;21(1):30-6. No 

measure of sexual dysfunction reported. 

Chapelle PA, Colbeau-Justin P, Durand J, et al. 

[Ejaculation problems in traumatic paraplegia ]. [French]. 

Sem Hop 1982;58(28-29):1691-7. No measure of sexual 

dysfunction reported. 

Chen D, Hartwig DM, Roth EJ. Comparison of sperm 

quantity and quality in antegrade V retrograde ejaculates 

obtained by vibratory penile stimulation in males with 

spinal cord injury. Am J Phys Med Rehabil 1997;78(1):46-

55. No measure of sexual dysfunction reported. 

Chen D, Hartwig D, Jeyendran RS. Azoospermia - a unique 

challenge in the treatment of infertility in a spinal cord 

injured man. J Spinal Cord Med 2000;23(Suppl 1):43. No 

measure of sexual dysfunction reported. 

Chung PH, Palermo G, Schlegel PN, et al. The use of 

intracytoplasmic sperm injection with electroejaculates 

from anejaculatory men. Hum Reprod 1998;13(7):1854-8. 

No measure of sexual dysfunction reported. 

Colombel P, Egon G, Isambert JL. [Electrostimulation of 

anterior sacral nerve roots in spinal cord injury patients 

(evaluation of the 1st 25 cases)]. [French]. Prog Urol 

1992;2(1):41-9. Reported in a language other than English. 

Courtois FJ, Charvier KF, Leriche A, et al. Clinical 

approach to erectile dysfunction in spinal cord injured men. 

A review of clinical and experimental data. [Review] [60 

refs]. Paraplegia 1995;33(11):628-35. No measure of 

sexual dysfunction reported. 

Craven CBC, Mittmann N, Gordon M, et al. The cost utility 

of Viagra for treatment of erectile dysfunction in men after 

SCI. J Spinal Cord Med 2002;25(Suppl1):s44-s45. No 

measure of sexual dysfunction reported. 

Craven CBC, Mittmann N, Kaiser A, et al. The "hard truth" 

an information resource for men with SCI and erectile 

dysfunction. J Spinal Cord Med 2002;25(Suppl1):s44. No 

measure of sexual dysfunction reported. 

Creasey GH. Restoration of bladder, bowel, and sexual 

function. Topics in Spinal Cord Injury Rehabilitation 

1999;5(1):21-32. No measure of sexual dysfunction 

reported. 

Cross LL, Meythaler JM, Tuel SM, et al. Pregnancy, labor 

and delivery post spinal cord injury. Paraplegia 

1992;30(12):890-902. No measure of sexual dysfunction 

reported. 

Dahlberg A, Ruutu M, Hovatta O. Pregnancy results from a 

vibrator application, electroejaculation, and a vas aspiration 

programme in spinal-cord injured men. Hum Reprod 

1995;10(9):2305-7. No measure of sexual dysfunction 

reported. 

de Lamirande E, Leduc BE, Iwasaki A, et al. Increased 

reactive oxygen species formation in semen of patients with 

spinal cord injury. Fertil Steril 1995;63(3):637-42. No 

measure of sexual dysfunction reported. 

DeKoker B. Sex and the spinal cord. Sci Am 

1996;275(6):30-2. No measure of sexual dysfunction 

reported. 

Denil J, Kuczyk MA, Schultheiss D, et al. Use of assisted 

reproductive techniques for treatment of ejaculatory 

disorders. Andrologia. 1996;28 Suppl 1:43-51. No measure 

of sexual dysfunction reported. 

Denil J, Ohl D A, McGuire EJ, et al. Treatment of 

anejaculation with electroejaculation. Acta Urol Belg 

1992;60(3):15-25. No measure of sexual dysfunction 

reported. 

Dollfus P, Jurascheck F, Adli G, et al. Impairment of 

erection after external sphincter resection. Paraplegia 

1976;13(4):290-293. No measure of sexual dysfunction 

reported. 

Donohue J, Gebhard P. The Kinsey Institute/Indiana 

University report on sexuality and spinal cord injury. 

Sexuality & Disability 1995;13(1):7-85. No sexual 

dysfunction intervention reported. 
65

Drench ME. Impact of altered sexuality and sexual function 

in spinal cord injury: A review. Sex Disabil 1992;10(1):11-

4. No measure of sexual dysfunction reported. 

Ekland MB, Rines B A. Women's experience of sexual 

adjustment post spinal cord injury. J Spinal Cord Med 

2002;25(Suppl1):s44. No measure of sexual dysfunction 

reported. 

Ekland M, Griffin S, Copeland J, et al. Exploring male 

fertility options after spinal cord injury: the role of the 

nurse clinician. [Review] [7 refs]. SCI Nurs 1998;15(4):95-

8. No measure of sexual dysfunction reported. 

Elliott S. Anejaculation, fertility and sex. Can J Hum Sex 

1996;2(3):124-7. No measure of sexual dysfunction 

reported. 

Elliott SL, Griffin S, Ekland M, et al. Vibrostimulation - 

techniques and results. J Spinal Cord Med 2000;23(3):175. 

No measure of sexual dysfunction reported. 

Elliott SL, Nigro M, Ekland MB, et al. The Vancouver 

experience: sperm retrieval program. J Spinal Cord Med 

2002;25(Suppl 1):s14. No measure of sexual dysfunction 

reported. 

Fernandez JB, Barber DB, Able AC, et al. Acute spinal 

cord injury in pregnancy: cases and literature review. J 

Spinal Cord Med 2000;23(3):182. No measure of sexual 

dysfunction reported. 

Fisher T, Byfield G, Tymus T, et al. The profile of sexual 

health needs of individuals one year after spinal cord 

injury. J Spinal Cord Med 2001;24(Suppl 1):s35. No 

measure of sexual dysfunction reported. 

Francois N. [Genital sexual and procreation disorders in 

patients with spinal cord injuries]. [French]. Rev Prat 

1995;45(16):2017-21. Reported in a language other than 

English. 

Francois N, Maury M. Sexual aspects in paraplegic 

patients. Paraplegia 1987;25(3):289-92. No measure of 

sexual dysfunction reported. 

Francois N, Jouannet P, Maury M. [Genitosexual function 

of paraplegics]. [French]. J Urol (Paris) 1983;89(3):159-64. 

Reported in a language other than English. 

Francois N, Maury M, David G, et al. [Electric stimulation 

of ejaculation in paraplegia. Possibilities of impregnation 

using artificial insemination]. [French]. Acta Urol Belg 

1979;47(1):173-86. No measure of sexual dysfunction 

reported. 

Green BG, Killorin EW, Bennett JK, et al. Erectile 

response following administration of sildenafil citrate 

(ViagraO) in the neuropathic patient:initial results. J Spinal 

Cord Med 1999;22(1):48. Not an original report of an 

intervention trial with pre and post measures. 

Green B, Killorin EW, Rozas K, et al. Results of elective 

electroejaculation with freezing and subsequent sperm 

manipulation versus electroejaculation at ovulation to 

achieve pregnancy in male factor spinal cord injured males. 

J Spinal Cord Med 2000;23(Suppl 1):45. No measure of 

sexual dysfunction reported. 

Grossiord A, Chapelle P A, Lacert P, et al. [The affected 

medullary segment in paraplegics. Relation to sexual 

function in men (author's transl)]. [French]. Rev Neurol 

(Paris) 1978;134(12):729-40. No measure of sexual 

dysfunction reported. 

Grundy D, Russell J. ABC of spinal cord injury. Later 

management and complications--I. Br Med J (Clin Res Ed). 

1986;292(6521):677-80. No measure of sexual dysfunction 

reported. 

Guldin A. Self-claiming sexuality: Mobility impaired 

people and American culture. Sex Disabil 2000;18(4):225-

38. No measure of sexual dysfunction reported. 

Halstead LS, Seager SWJ. Fertility aspects of Men with 

spinal cord injury: results obtained by electroejaculation. 

Arch Phys Med Rehabil 1999;80:1119. No measure of 

sexual dysfunction reported. 

Halstead LS, VerVoort S, Seager SW. Rectal probe 

electrostimulation in the treatment of anejaculatory spinal 

cord injured men. Paraplegia 1987;25(2):120-9. No 

measure of sexual dysfunction reported. 

Hatzichristou DG. Sildenafil citrate: lessons learned from 3 

years of clinical experience. Int J Impot Res 2002;14 Suppl 

1(S43):S52. No measure of sexual dysfunction reported. 

Hellstrom WJ, Stone AR, Deitch AD, et al. The clinical 

application of aspiration deoxyribonucleic acid flow 

cytometry to neurologically impaired men entering an 

electroejaculation program. Br J Urol 1989;142(2 Pt 

1):309-12. No measure of sexual dysfunction reported. 

Heruti RJ, Katz H, Menashe Y, et al. Treatment of male 

infertility due to spinal cord injury using rectal probe 

electroejaculation: the Israeli experience. Proc Annu Clin 

Spinal Cord Inj Conf 2001;39(3):168-75. No measure of 

sexual dysfunction reported. 

Higgins GE. Sexual response in spinal cord injured adults: 

a review of the literature. Arch Sex Behav 1979;8(2):173-

96. No measure of sexual dysfunction reported. 

Hirsch IH, Jeyendran RS, Sedor J, et al. Biochemical 

analysis of electroejaculates in spinal cord injured men: 

comparison to normal ejaculates. Br J Urol 1991;145(1):73-

6. No measure of sexual dysfunction reported. 
66

Hirsch IH, Kulp-Hugues D, Sedor J, et al. Simplified and 

objective assessment of spermatogenesis in spinal cord 

injured men by flow cytometry analysis. Paraplegia 

1993;31(12):785-92. No measure of sexual dysfunction 

reported. 

Hirsch IH, McCue P, Allen J, et al. Quantitative testicular 

biopsy in spinal cord injured men: comparison to fertile 

controls. Br J Urol 1991;146(2):337-41. No measure of 

sexual dysfunction reported. 

Hirsch IH, Sedor J, Callahan HJ, et al. Systemic sperm 

autoimmunity in spinal-cord injured men. Arch Androl 

1990;25(1):69-73. No measure of sexual dysfunction 

reported. 

Hirsch IH, Sedor J, Kulp D, et al. Objective assessment of 

spermatogenesis in men with functional and anatomic 

obstruction of the genital tract. Int J Androl 1994;17(1):29-

34. No measure of sexual dysfunction reported. 

Hohmann GW. Considerations in management of 

psychosexual readjustment in the cord injured male. Proc 

Veterans Adm Spinal Cord Inj Conf. 1971;18:199-204. No 

measure of sexual dysfunction reported. 

Holstein AF, Sauerwein D, Schirren U. [Spermatogenesis 

in patients with traumatic transverse paralysis]. [German]. 

Rev Med Interna Neurol Psihiatr Neurochir 

Dermatovenerol Med Interna 1985;24(4):208-15. Reported 

in a language other than English. 

Hovatta O, von Smitten K. Sperm aspiration from vas 

deferens and in-vitro fertilization in cases of non-treatable 

anejaculation. Hum Reprod 1993;8(10):1689-91. No 

measure of sexual dysfunction reported. 

Howitt HP. Psychological aspects of sexual adjustment in 

the spinal cord injured. Conn Nurs News line 27 No sexual 

dysfunction intervention reported. 

Hudson BS. Erectile dysfunction options for SCI males. 

17th American association of spinal cord injury nurses 

conference 2000;34. No measure of sexual dysfunction 

reported. 

Hultling C, Levi R, Garoff L, et al. Assisted ejaculation 

combined with in vitro fertilisation: an effective technique 

treating male infertility due to spinal cord injury. 

Paraplegia 1994;32(7):463-7. No measure of sexual 

dysfunction reported. 

Hultling C, Rosenlund B, Levi R, et al. Assisted ejaculation 

and in-vitro fertilization in the treatment of infertile spinal 

cord-injured men: the role of intracytoplasmic sperm 

injection. Hum Reprod 1997;12(3):499-502. No measure of 

sexual dysfunction reported. 

Iwatsubo E, Iwakawa A, Koga H, et al., [Clinical studies on 

the management of urogenital dysfunction in patients with 

spinal cord injury. 1. Noninflatable penile prosthesis for the 

management of urinary incontinence and sexual disability]. 

[Japanese]. Nippon Hinyokika Gakkai Zasshi. 

1986;77(5):760-5. Reported in a language other than 

English. 

Jackson RW. Sexual rehabilitation after cord injury. 

Paraplegia 1972;10(1):50-5. No measure of sexual 

dysfunction reported. 

Jouannet P, Francois N, Maury M. [Evaluation of fertility 

in paraplegic men]. [French]. J Urol (Paris) 

1983;89(3):169-71. No measure of sexual dysfunction 

reported. 

Keeshin S, Lane G, Kanter S, et al. Medical and 

psychosocial issues in women with spinal cord injury: a 

comprehensive survey. Arch Phys Med Rehabil 

1999;80:1119. No measure of sexual dysfunction reported. 

Key BH, Hale AM, Jackson AB. Promoting accessible 

health care examinations for women with SCI. 15th 

American association of spinal cord injury nurses 

conference 1998;43. No measure of sexual dysfunction 

reported. 

Kimoto Y, Iwatsubo E. Penile prostheses for the 

management of the neuropathic bladder and sexual 

dysfunction in spinal cord injury patients: long term follow 

up. Paraplegia 1994;32(5):336-9. No measure of sexual 

dysfunction reported. 

Kimura Y. [Sexual function of the paraplegics; with a 

special reference to erection and ejaculation]. [Japanese]. 

Nippon Hinyokika Gakkai Zasshi. 1970;61(10):1010-6. 

Reported in a language other than English. 

Kolon TF, Philips KA, Buch JP. Pentoxifylline 

enhancement of post-thaw motility in cryopreserved semen 

of spinal cord-injured men. Int J Fertil Menopausal Stud 

1995;40(3):156-60. No measure of sexual dysfunction 

reported. 

Komisaruk BR. The suppression of pain by genital 

stimulation in females. Annu Rev Sex Res 

1995;VI(151):186. No measure of sexual dysfunction 

reported. 

Kulkarni S, Morgan OS. Pregnancy outcome in paraplegic 

women. West Indian Med J 1992;41(3):99-100. No 

measure of sexual dysfunction reported. 

Langtry HD, Markham A. Sildenafil: a review of its use in 

erectile dysfunction.. Drugs 1999;57(6):967-89. No 

measure of sexual dysfunction reported. 
67

Le Chapelain L, Nguyen Van, Tam Dehail P, et al. 

Ejaculatory stimulation, quality of semen and reproductive 

aspects in spinal cord injured men. Proc Annu Clin Spinal 

Cord Inj Conf 1998;36(2):132-6. No measure of sexual 

dysfunction reported. 

Lebib BA, Laffont I, Boyer F, et al. Intracavernous 

injections in the treatment of erectile dysfunction in spinal 

cord injured patients: experience with 36 patients. [French]. 

Ann Readapt Med Phys 2001;44(1):35-40. Reported in a 

language other than English. 

Leduc BE, Roy D, Poulin O. The use of physostigmine in 

men with spinal cord injury with ejaculatory dysfunction. 

Can J Rehabil 1992;5(4):231-5. No measure of sexual 

dysfunction reported. 

Lewis JH. What's new in the treatment of erectile 

dysfunction. 15th American association of spinal cord 

injury nurses conference 1998;21. No measure of sexual 

dysfunction reported. 

Leyson J. Foreword. Sex Disabil 1995;13(1):5. No measure 

of sexual dysfunction reported. 

Lim TC, Mallidis C, Hill ST, et al. A simple technique to 

prevent retrograde ejaculation during assisted ejaculation. 

Paraplegia 1994;32(3):142-9. No measure of sexual 

dysfunction reported. 

Lindsey LL, Brown JF. VIAGRA (sildenafil) and spinal 

cord injury: review and update. SCI Psychosocial Process 

2000;13(1):13-6. No measure of sexual dysfunction 

reported. 

Linsenmeyer TA. Evaluation and treatment of erectile 

dysfunction following spinal cord injury: a review. 

[Review] [65 refs]. J Am Paraplegia Soc 1991;14(2):43-51. 

No measure of sexual dysfunction reported. 

Linsenmeyer TA. Management of male infertility. Vet J Ed 

487-509. No measure of sexual dysfunction reported. 

Linsenmeyer TA. Overview of male infertility following 

SCI. J Spinal Cord Med 2000;23(3):174. No measure of 

sexual dysfunction reported. 

Linsenmeyer TA, Perkash I. Infertility in men with spinal 

cord injury. Arch Phys Med Rehabil 1991;72(10):747-54. 

No measure of sexual dysfunction reported. 

Linsenmeyer T, Ottenweller J, Anesetti R. Effects of 

Vitamin E/Selenium on sperm motility following SCI. J 

Spinal Cord Med 1998;21(2):164. No measure of sexual 

dysfunction reported. 

Linsenmeyer T, Wilmot C, Anderson RU. The effects of 

the electroejaculation procedure on sperm motility. 

Paraplegia 1989;27(6):465-9. No measure of sexual 

dysfunction reported. 

Linton SS. Sexual satisfaction following spinal cord injury 

as a function of locus of control. Acta Radiol line 27 No 

measure of sexual dysfunction reported. 

Loecher-Ernst D, Grosse J, Mandalka B, et al. Semen 

retrieved and fertility in 229 spinal cord injured 

males:longterm results of a fertility program in spinal cord 

injured males. J Spinal Cord Med 1998;21(2):164. No 

measure of sexual dysfunction reported. 

Loughead R M. Males' perception of changes in their sex 

role orientation as a function of spinal cord injury. Bull 

Acad Natl Chir Dent. No sexual dysfunction intervention 

reported. 

Lucas MG, Hargreave TB, Edmond P, et al. Sperm 

retrieval by electro-ejaculation. Preliminary experience in 

patients with secondary anejaculation. Br J Urol 

1991;67(2):191-4. No measure of sexual dysfunction 

reported. 

Mallidis C, Lim TC, Hill ST, et al. Collection of semen 

from men in acute phase of spinal cord injury. Lancet. 

1994;343(8905):1072-3. No measure of sexual dysfunction 

reported. 

Mauney MC. Fertility program/electroejaculationcoordination of services. 17th American association of 

spinal cord injury nurses conference 2000;34-5. No 

measure of sexual dysfunction reported. 

May AC. Sex differences related to adjustment to spinal 

cord injury. Monogr Am Assoc Ment Defic. No measure of 

sexual dysfunction reported. 

McBride K E, Rines B. Sexuality and SCI: a roadmap for 

nurses. 15th American association of spinal cord injury 

nurses conference 1998;19. No measure of sexual 

dysfunction reported. 

McKenna KE. Neural circuitry involved in sexual function. 

[Review] [78 refs]. J Spinal Cord Med 2001;24(3):148-54. 

No measure of sexual dysfunction reported. 

Momose H, Hirao Y, Yamamoto M, et al. 

Electroejaculation in patients with spinal cord injury: first 

report of a large-scale experience from Japan. Int J Urol 

1995;2(5):326-29. No measure of sexual dysfunction 

reported. 

Momose H, Natsume O, Yamamoto M, et al. 

[Intracavernous injection of papaverine hydrochloride for 

impotence in patients with spinal cord injury]. [Japanese]. 

Hinyokika Kiyo 1987;33(7):1065-9. Reported in a 

language other than English. 

Monga M, Bernie J, Rajasekaran M. Male infertility and 

erectile dysfunction in spinal cord injury: a review. 

Archives of Physical Medicine & Rehabilitation 

1999;80(10):1331-9. No measure of sexual dysfunction 

reported. 
68

Murphy DF. Sexual health information sheets. 15th 

American association of spinal cord injury nurses 

conference 1998;37-8. No measure of sexual dysfunction 

reported. 

Nehra A, Moreland RB. Neurologic erectile dysfunction. 

Urol Clin North Am 2001;28(2):289-308. No measure of 

sexual dysfunction reported. 

Nehra A, Werner MA, Bastuba M, et al. Vibratory 

stimulation and rectal probe electroejaculation as therapy 

for patients with spinal cord injury: semen parameters and 

pregnancy rates. Br J Urol 1996;155( 2):554-9. No measure 

of sexual dysfunction reported. 

Odum L, Sonksen J, Biering-Sorensen F. Seminal 

somatostatin in men with spinal cord injury. Paraplegia 

1995;33(7):374-6. No measure of sexual dysfunction 

reported. 

Ohl DA, Bennett CJ, McCabe M, et al. Predictors of 

success in electroejaculation of spinal cord injured men. Br 

J Urol 1989;142(6):1483-6. No measure of sexual 

dysfunction reported. 

Ohl DA, Denil J, Fitzgerald-Shelton K, et al. Fertility of 

spinal cord injured males: effect of genitourinary infection 

and bladder management on results of electroejaculation. J 

Am Paraplegia Soc 1992;15(2):53-9. No measure of sexual 

dysfunction reported. 

Ohl DA, Sonksen J, Menge AC, et al. Electroejaculation 

versus vibratory stimulation in spinal cord injured men: 

sperm quality and patient preference. Br J Urol 

1997;157(6):2147-9. No measure of sexual dysfunction 

reported. 

Padma-Nathan H, Giuliano F. Oral drug therapy for erectile 

dysfunction.. Urol Clin North Am 2001;28(2):321-34. No 

measure of sexual dysfunction reported. 

Padron OF, Brackett NL, Weizman MS, et al. Semen of 

spinal cord injured men freezes reliably. J Androl 

1994;15(3):266-9. No measure of sexual dysfunction 

reported. 

Park CI, Shin J, Kim D, et al. Ejaculatory induction and 

semen analysis with vibratory and electrical stimulation in 

spinal cord injured patients. Arch Phys Med Rehabil 

1999;80:1195. No measure of sexual dysfunction reported. 

Peckham PH, Creasey GH. Neural prostheses: clinical 

applications of functional electrical stimulation in spinal 

cord injury. Paraplegia 1992;30(2):96-101. No measure of 

sexual dysfunction reported. 

Perduta-Fulginiti PS. Sexual functioning of women with 

complete spinal cord injury: Nursing implications. Sex 

Disabil 1993;10(2):115-8. No measure of sexual 

dysfunction reported. 

Perkash I, Martin DE, Warner H. Reproductive problems of 

paraplegics and the present status of electroejaculation. 

Cent Nerv Syst Trauma 1986;3(1):13-23. No measure of 

sexual dysfunction reported. 

Perkash I, Martin DE, Warner H et al., Electroejaculation 

in spinal cord injury patients: simplified new equipment 

and technique. Br J Urol 1990;143(2):305-7. No measure of 

sexual dysfunction reported. 

Perkash I, Martin DE, Warner H, et al. Reproductive 

biology of paraplegics: results of semen collection, 

testicular biopsy and serum hormone evaluation. Br J Urol 

1985;134(2):284-8. No sexual dysfunction intervention 

reported. 

Phelps J, Albo M, Dunn K, et al. Spinal cord injury and 

sexuality in married or partnered men: activities, function, 

needs, and predictors of sexual adjustment. Arch Sex 

Behav 2001;30(6):591-602. Not an original report of an 

intervention trial with pre and post measures. 

Piera JB. The establishment of a prognosis for genitosexual function in the paraplegic and tetraplegic male. 

Paraplegia 1973;10(4):271-8. No measure of sexual 

dysfunction reported. 

Powers J, Meats J, Saylor L, et al. Care of a pregnant spinal 

cord injured patient. 17th American association of spinal 

cord injury nurses conference 2000;40. No measure of 

sexual dysfunction reported. 

Pryor JL, Kuneck PH, Blatz SM, et al. Delayed timing of 

intrauterine insemination results in a significantly improved 

pregnancy rate in female partners of quadriplegic men. 

Fertil Steril 2001;76(6):1130-5. No measure of sexual 

dysfunction reported. 

Rajasekaran M, Monga M. Cellular and molecular causes 

of male infertility in spinal cord injury. [Review] [52 refs]. 

J Androl 1999;20(3):326-30. No measure of sexual 

dysfunction reported. 

Rawicki HB, Hill S. Semen retrieval in spinal cord injured 

men. Paraplegia 1991;29(7):443-6. No measure of sexual 

dysfunction reported. 

Raymond CA. New use for old method of inducing 

ejaculation may give hope of fatherhood to some spinal 

cord-injured men. JAMA. 1987;258(6):743-4. No measure 

of sexual dysfunction reported. 

Rivas DA. Management of erectile dysfunction. Vet J Ed 

457-464. No measure of sexual dysfunction reported. 

Roberts R. A case study of the experiences of six women 

who are paraplegic. Farmaco. No sexual dysfunction 

intervention reported. 
69

Romeo AJ. Sexual adjustment to spinal-cord injury. 

Microcirculation. No measure of sexual dysfunction 

reported. 

Rossier AB, Fam BA. Indication and results of semirigid 

penile prostheses in spinal cord injury patients: long-term 

followup. Br J Urol 1984;131(1):59-62. No measure of 

sexual dysfunction reported. 

Rucker B, Szasz G, Carpenter C. Legal, ethical and 

religious issues related to fertility enhancement of men with 

spinal cord injuries. Can J Rehabil 1988;1(4):225-31. No 

measure of sexual dysfunction reported. 

Rutkowski SB, Geraghty TJ, Hagen DL, et al. A 

comprehensive approach to the management of male 

infertility following spinal cord injury. Proc Annu Clin 

Spinal Cord Inj Conf 1999;37(7):508-14. No measure of 

sexual dysfunction reported. 

Rutkowski B, Middleton JW, Truman G, et al. The 

influence of bladder management on fertility in spinal cord 

injured males. Paraplegia 1995;33(5):263-6. No measure of 

sexual dysfunction reported. 

Sadovsky R, Miller T, Moskowitz M, et al. Three-year 

update of sildenafil citrate (Viagra) efficacy and safety. Int 

J Clin Pract 2001;55(2):115-28. No measure of sexual 

dysfunction reported. 

Sanchez RA, Vidal J, Juregui ML,et al. Efficacy, safety and 

predictive factors of therapeutic success with sildenafil for 

erectile dysfunction in patients with different spinal cord 

injuries. Proc Annu Clin Spinal Cord Inj Conf 

2001;39(12):637-43. No measure of sexual dysfunction 

reported. 

Sarkarati M, Rossier AB, Fam BA. Experience in vibratory 

and electro-ejaculation techniques in spinal cord injury 

patients: a preliminary report. Br J Urol 1987;138(1):59-62. 

No measure of sexual dysfunction reported. 

Schatte EC, Orejuela FJ, Lipshultz LI, et al. Treatment of 

infertility due to anejaculation in the male with 

electroejaculation and intracytoplasmic sperm injection. Br 

J Urol 2000;163(6):1717-20. No measure of sexual 

dysfunction reported. 

Scheutzow MH, Bockenek WL. Electroejaculation in 

persons with spinal cord injury: a unique complication and 

review of the literature. Arch Phys Med Rehabil 

1998;79:1187. No measure of sexual dysfunction reported. 

Seager SW, Halstead LS. Fertility options and success after 

spinal cord injury. [Review] [32 refs]. Urol Clin North Am 

1993;20(3):543-8. No measure of sexual dysfunction 

reported. 

Seager SWJ, Halstead LS. Electroejaculation - techniques 

and results. J Spinal Cord Med 2000;23(3):174. No 

measure of sexual dysfunction reported. 

Seftel AD. Disturbed sexual function in patients with spinal 

cord disease. Neurol Clin 1991;9(3):757-78. No measure of 

sexual dysfunction reported. 

Seftel AD, Bodner DR, Gothe B, et al. Efficacy of 

sildenafil in spinal cord injured men. J Spinal Cord Med 

2000;23(3):207. No measure of sexual dysfunction 

reported. 

Shaban SF, Seager SW, Lipshultz LI. Clinical 

electroejaculation. [Review] [31 refs]. Med Instrum 

1988;22(2):77-81. No measure of sexual dysfunction 

reported. 

Siosteen A. Emission dysfunctions and current modes of 

treatment in neurogenic male infertility. Scand J Urol 

Nephrol 1988;Supplementum. 110(59):64. No measure of 

sexual dysfunction reported. 

Siosteen A, Forssman L, Steen Y, et al. Quality of semen 

after repeated ejaculation treatment in spinal cord injury 

men. Paraplegia 1990;28(2):96-104. No measure of sexual 

dysfunction reported. 

Siosteen A, Steen Y, Forssman L, et al. Auto-immunity to 

spermatozoa and quality of semen in men with spinal cord 

injury. Int J Fertil 1993;38(2):117-22. No measure of 

sexual dysfunction reported. 

Sipski ML. Future options for improving sexual satisfaction 

in persons with spinal cord injuries. The Howard H. Steel 

Conference on Pediatric Spinal Cord Injury, Rancho 

Mirage, California, December 3-5, 1999. Topics in Spinal 

Cord Injury Rehabilitation 2000;6(148):154. No measure of 

sexual dysfunction reported. 

Sipski ML. Sexual response in women with spinal cord 

injury: neurologic pathways and recommendations for the 

use of electrical stimulation. [Review] [21 refs]. J Spinal 

Cord Med 2001;24(3):155-8. No measure of sexual 

dysfunction reported. 

Sipski ML. Central nervous system based neurogenic 

female sexual dysfunction: Current status and future trends. 

Arch Sex Behav 2002;31(5):421-4. No measure of sexual 

dysfunction reported. 

Sipski ML. Spinal cord injury and sexual function: An 

educational model. Vet J Ed 149-176. No measure of 

sexual dysfunction reported. 

Sipski ML. A controlled trial of positive feedback to 

increase sexual arousal in women with spinal cord injuries. 

NeuroRehabilitation 2000;15(2):145-53. No measure of 

sexual dysfunction reported. 

Sipski ML, Behnegar A. Neurogenic female sexual 

dysfunction: a review. [Review] [53 refs]. Clin Auton Res 

2001;11(5):279-83. No measure of sexual dysfunction 

reported. 
70

Sipski ML, Katz MA, Blight AR. The effects of oral 

fampridine-SR (sustained-release 4-aminopyridine) on 

sexual function in subjects with chronic motor-incomplete 

spinal cord injury. J Spinal Cord Med 2003;26(Suppl 

1):s18. No measure of sexual dysfunction reported. 

Sonksen JO, Biering-Sorensen F, Kristensen JK, et al. 

[Ejaculation induced by electrostimulation in men with 

spinal cord injuries]. [Danish]. Ugeskr Laeger 

1993;155(3):176-9. Reported in a language other than 

English. 

Sonksen JO, Hansen E F, Biering-Sorensen F et al., 

Intracavernous self-injection for treatment of erectile 

dysfunction inpatients with spinal cord injuries. [Danish]. 

Ugeskr Laeger 1990;152(41):3006-9. Reported in a 

language other than English. 

Sonksen J, Biering-Sorensen F, Kristensen JK. Ejaculation 

induced by penile vibratory stimulation in men with spinal 

cord injuries. The importance of the vibratory amplitude. 

Paraplegia 1994;32(10):651-60. No measure of sexual 

dysfunction reported. 

Sonksen J, Sommer P, Biering-Sorensen F et al., Pregnancy 

after assisted ejaculation procedures in men with spinal 

cord injury. Arch Phys Med Rehabil 1997;78(10):1059-61. 

No measure of sexual dysfunction reported. 

Sprouse DO. Electroejaculation for anejaculate males. Urol 

Nurs 1994;14(2):57-61. No measure of sexual dysfunction 

reported. 

Sprouse DO. Fertility issues and anejaculation. Urol Nurs 

1994;14(2):62-5. No measure of sexual dysfunction 

reported. 

Staerman F, Bryckaert PE, Youinou Y, et al. 

[Pharmacologic stimulation of ejaculation with midodrine 

hydrochloride (Gutron) for medically assisted reproduction 

in spinal injury]. [French]. Prog Urol. 2001;11(6):1264-8. 

No measure of sexual dysfunction reported. 

Stein Mark. The evaluation and treatment of sexual 

dysfunction in the neurologically impaired patient. J Neurol 

Rehabil 1993;7(2):63-71. No measure of sexual 

dysfunction reported. 

Stien R. Sexual dysfunctions in the spinal cord injured. 

Paraplegia 1992;30(1):54-7. No measure of sexual 

dysfunction reported. 

Szasz G, Carpenter C. Clinical observations in vibratory 

stimulation of the penis of men with spinal cord injury. 

Arch Sex Behav 1989;18(6):461-74. No measure of sexual 

dysfunction reported. 

Tarabulcy E. Sexual function in the normal and in 

paraplegia. Paraplegia 1972;10(3):201-8. No measure of 

sexual dysfunction reported. 

Taylor Z, Molloy D, Hill V, et al. Contribution of the 

assisted reproductive technologies to fertility in males 

suffering spinal cord injury. Aust N Z J Obstet Gynaecol 

1999;39(1):84-7. No measure of sexual dysfunction 

reported. 

Tepper MS. Lived experiences that impede or facilitate 

sexual pleasure and orgasm in people with spinal cord 

injury. J Womens Health (Larchmt). No sexual dysfunction 

intervention reported. 

Tepper MS. Providing comprehensive sexual health care in 

SCI rehabilitation. 15th American association of spinal 

cord injury nurses conference 1998;26. No measure of 

sexual dysfunction reported. 

Thomas AJ. Ejaculatory dysfunction. Fertil Steril 

1983;39(4):445. No measure of sexual dysfunction 

reported. 

Tollon C, Soulie M, Pontonnier F, et al. [Prevention of 

sterility in spinal cord injured men]. [French]. Prog Urol 

1997;7(2):203-8. No measure of sexual dysfunction 

reported. 

Truss MC, Djamilian MH, Tan HK, et al. Single potential 

analysis of cavernous electrical activity. Four years' 

experience in more than 500 patients with erectile 

dysfunction. Eur Urol 1993;24(3):358-65. No sexual 

dysfunction intervention reported. 

Urey Jon R. Marital adjustment following spinal cord 

injury: An analysis of recreational, sexual and conflict 

resolution behaviors. ADM. No measure of sexual 

dysfunction reported. 

Vaidyanathan S, Soni BM, Krishnan KR. Special 

precautions to be observed while using alprostadil in 

patients with spinal cord injury. Proc Annu Clin Spinal 

Cord Inj Conf 1997;35(6):402-3. No measure of sexual 

dysfunction reported. 

van der, Linde I. Oral sildenafil (Viagra) on trial., S Afr 

Med J 1998;88( 10):1290. No measure of sexual 

dysfunction reported. 

Veit N, Mikelonis M. Health Issues of women who have 

spinal cord impairment. 18th American association of 

spinal cord injury nurses conference 2001;25-25. No 

measure of sexual dysfunction reported. 

Velasco M, Buyo A, Barrera S et al., Sexual and 

gynecologic issues in a sample of women with spinal cord 

injury. J Spinal Cord Med 2002;25( Suppl1):s45. No 

measure of sexual dysfunction reported. 

Ver Voort SM. Infertility in spinal-cord injured male.. 

Urology 1987;29(2):157-65. No measure of sexual 

dysfunction reported. 
71

VerVoort SM, Donovan WH, Dykstra DD, et al. Increased 

current delivery and sperm collection using nifedipine 

during electroejaculation in men with high spinal cord 

injuries. Arch Phys Med Rehabil 1988;69(8):595-7. No 

measure of sexual dysfunction reported. 

Wagenknecht LV. Alloplastic spermatocele: 20 years 

experience and perspectives. Acta Chir Hung 1994;34:207-

29. No measure of sexual dysfunction reported. 

Wang YH, Chiang HS, Wu CH, et al. Electroejaculation in 

spinal cord injured males. J Formos Med Assoc 

1992;91(4):413-8. No measure of sexual dysfunction 

reported. 

Wang YH, Huang TS, Lien IN. Hormone changes in men 

with spinal cord injuries. Am J Phys Med Rehabil 

1992;71(6):328-32. No sexual dysfunction intervention 

reported. 

Wang YH, Huang TS, Lin MC, et al. Scrotal temperature in 

spinal cord injury. Am J Phys Med Rehabil 1993;72(1):6-9. 

No measure of sexual dysfunction reported. 

Warner H, Martin DE, Perkash I, et al. Electrostimulation 

of erection and ejaculation and collection of semen in 

spinal cord injured humans. J Rehabil Res Devel 

1986;23(3):21-31. No measure of sexual dysfunction 

reported. 

Weinberg JS. Human Sexuality and spinal cord injury. Crit 

Care Nurs Clin North Am 1982;17(3):407-19. No measure 

of sexual dysfunction reported. 

Whipple B, Komisaruk BR. Brain (PET) responses to 

vaginal-cervical self-stimulation in women with complete 

spinal cord injury: preliminary findings. J Sex Marital Ther 

2002;28(1):79-86. No measure of sexual dysfunction 

reported. 

Willmuth ME. Sexuality after spinal cord injury: A critical 

review. Clin Psychol Rev 1987;7(4):389-412. No measure 

of sexual dysfunction reported. 

Wolski JK, Kluge P, Koziol K, et al. [Needle testicular 

biopsy in the diagnosis of male infertility]. [Polish]. 

Ginekol Pol 1998;69(6):541-4. No measure of sexual 

dysfunction reported. 

Wyndaele JJ, de Meyer JM, de Sy WA, et al. 

Intracavernous injection of vasoactive drugs, an alternative 

for treating impotence in spinal cord injury patients. 

Paraplegia 1986;24(5):271-5. No measure of sexual 

dysfunction reported. 

Yamamoto M, Yamada K, Hirata N, et al. 

[Electroejaculation and assisted reproductive techniques in 

the patients with spinal cord injury]. [Japanese]. Nippon 

Hinyokika Gakkai Zasshi - Japanese Journal of Urology 

1997;88(3):420-6. Reported in a language other than 

English. 

Yarkony GM. Enhancement of sexual function and fertility 

in spinal cord-injured males. Am J Phys Med Rehabil 

1990;69(2):81-7. No measure of sexual dysfunction 

reported. 

Yarkony GM, Chen D. Sexuality in patients with spinal 

cord injury. Physical Medicine & Rehabilitation: State of 

the Art Reviews 1995;9(2):325-44. No measure of sexual 

dysfunction reported. 

Yarkony GM, Chen D, Palmer J, et al. Management of 

impotence due to spinal cord injury using low dose 

papaverine. Paraplegia 1995;33(2):77-9. No measure of 

sexual dysfunction reported. 

Zeller FL, Lassalle G, Repetti P, et al. Electromyographical 

findings in patients with spinal cord injury and erectile 

dysfunction. Int J Impot Res 2001;13(Suppl 2):s16. No 

sexual dysfunction intervention reported. 
Appendix A. Search Strategies 

Search Strategy 1 

1. comarr$.au. 

2. (Female Sexual Function Index or FSFI).mp. 

3. (Brief Index of Sexual Functioning or BISF-W).mp.

4. (Changes in Sexual Functioning Questionnaire or CSFQ).mp. 

5. (Derogatis Interview for Sexual Functioning or DISF).mp. 

6. (Golombok Rust Inventory of Sexual Satisfaction or GRISS).mp.

7. (International Index of Erectile Function or IIEF).mp. 

8. (Brief Male Sexual Function Inventory or BMSFI).mp. 

9. exp reproduction/ 

10. (reproducti$ or impoten$ or sex$ or ejaculat$ or erectile or menstruat$ or menopaus$ or 

hysterectom$ or infertil$ or orgasm$ or pregnanc$ or contracept$).mp. 

11. (gay or lesbian or bisexual$ or transgender$ or homosexual$).mp. 

12. or/2-11 

13. Spinal Cord Injuries/ 

14. Paraplegia/ 

15. Quadriplegia/ 

16. Traumatic cord.mp. 

17. post-traumatic myelopathy.mp. 

18. (spinal cord inj$ or parapleg$ or quadripleg$ or tetrapleg$).mp. 

19. meningomyelocele/ or spinal dysraphism/ or spina bifida cystica/ or spina bifida occulta/

20. (cerebral palsy not spinal cord).mp.

21. or/13-18

22. 21 not (19 or 20) 

23. limit 22 to animal 

24. limit 22 to human 

25. 23 and 24

26. 22 not (23 not 25) 

27. exp Sex Behavior/sn [Statistics & Numerical Data] 

28. sexual$ activ$.mp. 

29. sexual adjust$.mp. 

30. sex$ counsel$.mp. 

31. or/27-30

32. 12 and (sn or ep).fs. 

33. (31 or 32) and 26 

34. 12 and (1 or 26) 

35. limit 34 to female 

36. limit 34 to male 

37. 34 and (35 not 36) 

38. (menstruat$ or menopaus$ or hysterectom$ or pregnanc$).mp.

39. cesarean.mp. 

40. obstetr$.ti. 

41. obstetr$.mp. 

42. or/38-41

43. 12 and 26 and (37 or 42) 

44. 43 not 33

45. Fertility/ 

46. Birth Rate/ 

47. FERTILIZATION/ 

48. fertili$.mp. 

49. conception.mp.

50. infertility.mp. 

51. INFERTILITY, FEMALE/

A-1
Appendix A. Search Strategies (continued) 

52. infertility, male/ 

53. or/45-52

54. (53 and 26 and 34) not (33 or 44) 

55. limit 54 to (adolescence <13 to 18 years> or adult) 

56. viagra.mp. 

57. Sildenafil citrate.mp. 

58. Sildenafil.mp. 

59. midodrine.mp. 

60. Gutron.mp. 

61. Electroejaculat$.mp. 

62. Ultrex.mp.

63. Cialis$.mp. 

64. Vasomax$.mp. 

65. penile prosthesis.mp. 

66. (prosthes#s adj2 (penis or penile)).mp. 

67. (vacuum adj2 (constriction or device)).mp. 

68. ((negative pressure or suction) adj device).mp. [mp=title, abstract, cas registry/ec number word, mesh 

subject heading] 

69. negative pressure device$.mp. 

70. vibromassage.mp. 

71. massage.mp. 

72. vibration.mp. 

73. intracavernous.mp. 

74. Alprostadil.mp. 

75. PROSTAGLANDINS E, SYNTHETIC/ or PROSTAGLANDINS F/ 

76. Prostaglandin-e1.mp.

77. Papaverine.mp. 

78. surgical collection.mp. 

79. caverject.mp. 

80. (MUSE and prostaglandin).mp. 

81. Medicated Urethral System for Erection.mp. 

82. vas aspiration.mp. 

83. testicular biopsy.mp. 

84. aspiration.mp. 

85. or/56-84

86. 85 and 26

87. limit 86 to male 

88. (Impoten$ or erectile).mp. 

89. 86 and 88

90. ((87 or 89) and 34) not (33 or 44 or 45) 

91. or/56-60

92. limit 91 to female 

93. (92 and 26) not (33 or 44 or 55 or 90) 

94. 34 not (33 or 44 or 55 or 90 or 93) 

A-2
Appendix A. Search Strategies (continued) 

Search Strategy 2 

1. comarr$.au. 

2. (Female Sexual Function Index or FSFI).mp. 

3. (Brief Index of Sexual Functioning or BISF-W).mp.

4. (Changes in Sexual Functioning Questionnaire or CSFQ).mp. 

5. (Derogatis Interview for Sexual Functioning or DISF).mp. 

6. (Golombok Rust Inventory of Sexual Satisfaction or GRISS).mp.

7. (International Index of Erectile Function or IIEF).mp. 

8. (Brief Male Sexual Function Inventory or BMSFI).mp. 

9. sexual satisfaction/ 

10. (reproducti$ or impoten$ or sex$ or ejaculat$ or erectile or menstruat$ or menopaus$ or 

hysterectom$ or infertil$ or orgasm$ or pregnanc$ or contracept$).mp. 

11. (gay or lesbian or bisexual$ or transgender$ or homosexual$).mp. 

12. or/2-11 

13. Spinal Cord Injuries/ 

14. Paraplegia/ 

15. Quadriplegia/ 

16. Traumatic cord.mp. 

17. post-traumatic myelopathy.mp. 

18. (spinal cord inj$ or parapleg$ or quadripleg$ or tetrapleg$).mp. 

19. meningomyelocele/ or spinal dysraphism/ or spina bifida cystica/ or spina bifida occulta/

20. (cerebral palsy not spinal cord).mp.

21. or/13-18

22. 21 not (19 or 20) 

23. limit 22 to animal 

24. limit 22 to human 

25. 23 and 24

26. 22 not (23 not 25) 

27. 12 and (1 or 26) 

A-3
Appendix B. Letter to Industry Representative 

December 29, 2003 

Director, Research & Development 

Pfizer Global Research & Development 

Canada Head Office 

4747 Levy Street, Building B114 

St-Laurent, Quebec 

H4R 2P9

RE: Letter to Industry Representatives from the University of Ottawa Evidence-based 

Practice Center Investigating Sexuality and Reproductive Health Following Spinal 

Cord Injury

Dear Sir or Madam: 

I am writing on behalf of the University of Ottawa’s Evidence-based Practice Center. We are 

conducting two systematic reviews concerning sexuality and reproductive health following 

spinal cord injury. They are as follows:

1. What is the current fertility rate for men and women after SCI? 

2. How has the availability of Viagra and other remediation affected sexual 

function, frequency of activity, and adjustment after SCI? 

These reviews are being conducted under a contract from the Agency for Healthcare 

Research and Quality (AHRQ). We are contacting you to see if there is any evidence, 

including unpublished studies, abstracts and other documentation, that you want 

considered for inclusion in the reviews. 

For the fertility rate systematic review we will consider the following studies for possible 

inclusion: 

• All randomized or quasi-randomized (i.e., trials in which the treatment 

allocation method was intended to be random but might have been biased, for 

example, allocation by day of the week), studies or series of any treatment 

intervention for fertility after spinal cord injury. 

For the remediation systematic review we will consider the following types of studies for 

possible inclusion: 

• All randomized or quasi-randomized (i.e., trials in which the treatment 

allocation method was intended to be random but might have been biased, for 

example, allocation by day of the week), trials or series of any treatment 

intervention for sexual dysfunction after spinal cord injury. 

B-1 
Appendix B. Letter to Industry Representative (continued) 

Our focus is on human studies reported in English and limited to conventional 

interventions, so animal, chemical, or complementary and alternative medicine intervention 

studies are not necessary. 

The specific questions that the systematic review will address are detailed in the attachment. 

As well, we understand that we will require permission to cite any information provided to 

us and introduced into the public domain.

We look forward to receiving any information that you might have. 

Best regards, 

Dan Deforge, MD 

Physiatrist-in-Chief, TRC 

Chief, Division of PM&R 

The Rehabilitation Centre

505 Smyth Road, Rm. 1104 

Ottawa, Ontario, CANADA 

K1H 8M2 

Phone: +1 (613) 737-7350 x 5524 

Email: ddeforge@ottawahospital.on.ca 

c.c. David Moher, 

Co-Director, University of Ottawa Evidence-based Practice Center 

Director, Chalmers Research Group, Children’s Hospital of Eastern Ontario Research 

Institute. 

B-2 
Appendix C. Modified QUOROM Flow Chart

Modified QUOROM Flow Chart 

2127 Screened at Level 1 & Classified by topic 

1627 Failed to meet inclusion criteria: 

580 Not relevant to spinal cord injury

 410 Not sexuality or reproductive health 

 0 Limited to congenital abnormalities 

 285 Case report or opinion piece 

 274 No relevant measure reported 

 78 Not relevant to any of the questions 

0 Adolescent or child only

2420 Records identified from bibliographic databases 

339 Duplicate records removed 

46 Identified from conferences or manufacturers 

56 Included Studies 

180 Failed to meet inclusion criteria: 

130 No measure of fertility reported 

 6 No fertility intervention reported 

 13 Not an original report of an intervention trial 

 11 No pre and post intervention fertility rate reported 

 4 SCI results not reported separately

 16 Reported in a language other than English 

246 Eligible for assessment*: Fertility

66 Included Studies 

288 Eligible for assessment:*Sexual Dysfunction 

232 Failed to meet inclusion criteria: 

205 No measure of sexual dysfunction reported 

 12 No sexual dysfunction intervention reported

2 Not an original report of an intervention trial with 

pre and post measures 

0 SCI results not reported separately 

13 Reported in a language other than English 

*Note: some items were eligible for both reviews, therefore, the sum does not add up to the 

number of included studies. 

C-1 
Appendix D. Data Assessment and Data Abstraction Forms 

Relevance Assessment Forms 

Sexual Dysfunction Eligibility Criteria 

Measures of sexual dysfunction under consideration: 

A. Psychologic: Validated sexual function questionnaire for males and/or females, structured 

interviews with qualitative analysis, educational component, global efficiency, or patient logs. 

B. Physiologic: Penile and/or clitoral engorgement, endocrine, ultrasound testing of testicular 

size. 

1. Does the article contain an original report of a measure of sexual dysfunction? (see list above) 

Yes 

No 

Can't Tell 

Interventions under consideration for sexual dysfunction: 

A. Cognitive/behavioral: Masturbation, intercourse 

B. Device: Penile rings, vibrators, vacuum devices 

C. Prescription medications: Intracavernous injections, oral, subcutaneous injections, intrameatal 

MUSE, creams 

D. Surgical intervention; Penile implants, spinal cord stimulators or E. Hormonal interventions. 

2. Does the article discuss an intervention for sexual dysfunction? (see list above) 

Yes 

No 

Can't Tell 

3. Does the article report an original intervention trial or series with a pre and post measure for 

sexual dysfunction after spinal cord injury? 

Yes 

No 

Can't Tell 

D-1 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Fertility Eligibility Criteria 

Measures of fertility rates under consideration: 

Pregnancies, live birth rates, sperm motility, successful sperm harvesting, ejaculations, sperm

count, % viable sperm, hormonal, ovulation rates, cycle function, other measures of sperm

morphology, volume of ejaculation. 

1. Does the article contain an original report of a measure of fertility rates in males, females or 

both? 

Yes 

No 

Can't Tell 

 

Fertility interventions under consideration: 

1. Physical: masturbation, intercourse, or 

2. Device: vibration, electrode ejaculation, home insemination or 

3. Prescription medications: sympathetic agonists, physostigmine, etc., 

4. Surgical intervention; vas aspiration, testicular biopsy, ICSI, artificial insemination, spinal 

cord stimulators, or 

5. Laboratory techniques. 

 

2. Does the article discuss a fertility intervention? 

Yes 

No 

Can't Tell 

 

3. Does the article report an original intervention trial after spinal cord injury? 

Yes 

No 

Can't Tell 

 

4. Does the article include pre and post intervention fertility rates? 

Yes 

No 

Can't Tell 

5. Were results for SCI reported separately?

Yes 

No 

6. Is this a non-English language article?

Yes 

No 

D-2 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Data Abstraction Forms 

Sexual Dysfunction 

1. Initials of reviewer: 

2. Reference identification # (Refid): 

3. Author, Year: 

4. Number of review-relevant studies that this report describes 

5. Publication status (select one): 

6. If you answered ‘Other’ to the preceding question, specify: 

7. If other included reports refer to this same study, provide the Refid(s) 

8. Country in which the study was conducted (select all that apply):) 

9. If you answered ‘Other’ to the preceding question, specify: Number of sites: (text) 

10. Funding source type (select all that apply): 

11. Specify the funding source(s): 

12. Study design (select one): Other (Please specify) 

13. If you answered ‘Other’ to the preceding question, specify: 

14. Total # of individuals screened: 

15. Full sample size (enrolled in study): 

16. Full sample size (completing study): 

17. Full sample’s percentage of male participants: 

18. Comments, including notable differences between study arms / cohorts re ‘% male 

participants’: 

19. Mean age (SD/SE; range) of all study participants: 

20. Comments, including notable differences between study arms/cohorts re age: 

21. Sample's percentage of married participants: 

22. Comments, including notable differences between study arms/ cohorts re % of married 

participants: 

23. From which racial groups were participant’s drawn (select all that apply)?) 

24. Specify each racial group’s percentage/proportion of full sample: 

25. Comments, including notable differences between study arms/cohorts re racial 

composition: 

26. Specify each socioeconomic status group’s percentage/proportion of full sample: 

Comments, including notable differences between study arms/cohorts re socioeconomic 

status: 

27. Specify number of previous pregnancies: 

28. Specify patient prescription drug history specific to SCI versus other: 

29. Specify partner prescription drug history specific to SCI versus other: 

30. Specify previous sexual dysfunction of patient: 

31. Specify previous sexual dysfunction of partner: 

32. Specify previous sexual dysfunction treatment of patient (Note: treatment type, duration, 

dose etc.): 

33. Specify previous sexual dysfunction treatment of partner (Note: treatment type, duration, 

dose etc.): 

34. Specify patient history of STD: 

D-3 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

35. Specify partner history of STD: 

36. Specify patient psychiatric/psychological history (e.g., depression): 

37. Specify partner psychiatric/psychological history (e.g., depression): 

38. Specify pre-existing cognitive impairments: 

39. Specify previous patient drug and/or alcohol abuse: 

40. Specify previous partner drug and/or alcohol abuse: 

41. Specify patient general medical history including prior diseases, and/or conditions 

Specify partner general medical history including prior diseases, and/or conditions: 

Specify other causes of sexual dysfunction: 

42. Concurrent conditions (list all that apply): (text) 

43. Specify the type and severity (mean; SD/SE; range: with units) of each concurrent

condition, as well as how it was defined and diagnosed: 

44. Specify the percentage/proportion of the whole sample re each type of each concurrent 

condition: 

45. Comments, including notable differences between study arms/cohorts re concurrent 

conditions: 

46. Specify pre-study medications or treatments for each concurrent condition, with 

dose/frequency: 

47. Comments, including notable differences between study arms / cohorts re pre-study 

medication(s) or treatments, including dose/frequency: 

48. Specify cause of spinal cord injury: 

49. Specify the level of spinal cord injury: 

50. Specify ASIA Level: 

51. Specify duration since spinal cord injury: 

52. Please list general comments, including notable differences between arms/cohorts re 

participants' baseline control of condition? (e.g., do any red flags stand out between the 

groups?): 

53. List of study’s inclusion criteria: 

54. List of study’s exclusion criteria: 

55. Intention of study (select all that apply) 

56. Type of study (select one): 

57. Data were analyzed according to which criterion (select one)? 

58. Study duration, including units (includes run-in period protocol/duration, washout 

protocol/duration, etc.): 

59. Specify product name used for pharmacologic, device and/or other intervention(s): 

Specify name of manufacturer of pharmacologic, device or other intervention product: 

Medications allowed or mandated during the study (dose/ frequency): 

60. Comments, including notable differences between study arms/ cohorts re participants’ 

medication: 

61. Concurrent therapies (e.g., physiotherapy; occupational therapy; chiropractic; counseling 

etc.) allowed or mandated during the study (intensity; frequency; duration): 

62. Comments, including notable differences between study arms/ cohorts re participants’ 

concurrent therapies: 

63. Permitted or required medications or treatments for concurrent conditions (specify dose/ 

frequency, and for which concurrent condition): 

64. Outcomes assessed (e.g. efficacy, incidence, prevalence, etc): 

D-4 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

65. Number of study arm/ cohorts (note: in a cross-over trial, each different phase is 

considered an exposure / intervention arm): 

66. Define the study arms or cohorts of interest to the present review: (text Study arm

number: 

67. Sample size at study entry: (text) 

68. Sample size of those who completed the study: 

69. Intervention length (weeks, months): 

70. Arm Type/Group Type (placebo, active, control): 

71. Intervention/ exposure type (e.g. drug or placebo): 

72. Dose / frequency: 

73. Timing (AM, PM): 

74. Study arm number (Click here if there is no more arm/cohort): 

75. Sample size at study entry: 

76. Sample size of those who completed the study: 

77. Intervention length (weeks, months): 

78. Arm type (placebo, active, control): 

79. Intervention/ exposure type (e.g. drug or placebo): 

80. Dose / frequency: 

81. Timing (AM, PM): 

82. Study arm number (Click here if there is no more arm/cohort): 

83. Sample size at study entry: 

84. Sample size of those who completed the study: 

85. Intervention length (weeks, months): 

86. Arm type (placebo, active, control): 

87. Intervention/ exposure type (e.g. drug or placebo): 

88. Dose / frequency: 

89. Timing (AM, PM): 

90. Study arm number: 

91. Sample size at study entry: 

92. Sample size of those who completed the study: 

93. Intervention length (weeks, months): 

94. Arm type (placebo, active, control): 

95. Intervention/ exposure type (e.g. drug or placebo): Sexual Dysfunction: Quality 

Assessment 

96. Dose / frequency: 

97. Timing (AM, PM): 

98. Anatomic/Physiologic (e.g., clitoral engorgement; errection; penile tumes. girth; EMG; 

vaginal lubrication): 

99. Sexual satisfaction: 

100. Psychological (e.g., sexual functioning questionnaires; depression scale & scores): 

Infection rates: 

101. Divorce: 

102. Additional Outcomes Not Covered Above - Other(s): 

103. Specify Follow-up(s) (length; duration & results): 

104. Adverse events/ side effects reported in the present study (including local (e.g., 

infection); systemic (e.g., hypotension, death, etc.); 

D-5 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

105. Other (e.g., psychological etc.) per study arm/cohort: 

106. General Study Comments (Identify any problems with the research design (e.g., 

definition of placebo/control(s); inappropriateness of run-in and washout periods), or its 

implementation): 

D-6 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Fertility

1. Initials of reviewer: 

2. Reference identification # (Refid): 

3. Author, Year: 

4. Number of review-relevant studies that this report describes: 

5. Publication status (select one): 

6. If you answered ‘Other’ to the preceding question, specify: 

7. If other included reports refer to this same study, provide the Refid(s): 

8. Country in which the study was conducted (select all that apply): (check) 

9. If you answered ‘Other’ to the preceding question, specify: (text) 

10. Number of sites: (text) 

11. Funding source type (select all that apply): (check 

12. Specify the funding source(s): (text) 

13. Study design (select one): 

14. Other (Please specify) 

15. If you answered ‘Other’ to the preceding question, specify: (text) 

16. Total # of individuals screened: (text) 

17. Full sample size (enrolled in study): (text) 

18. Full sample size (completing study): (text) 

19. Full sample’s percentage of male participants: (text) 

20. Comments, including notable differences between study arms / cohorts re ‘% male 

participants’: (text) 

21. Mean age (SD/SE; range) of all study participants: (text) 

22. Comments, including notable differences between study arms/cohorts re age: (text) 

23. Sample's percentage of married participants: (text) 

24. Comments, including notable differences between study arms/ cohorts re % of married 

participants: (text) 

25. From which racial groups were participants drawn (select all that apply)? (check) 

Specify each racial group’s percentage/proportion of full sample: (text) 

26. Comments, including notable differences between study arms/cohorts re racial 

composition: 

27. Specify each socioeconomic status group’s percentage/proportion of full sample: (text) 

28. Comments, including notable differences between study arms/cohorts re socioeconomic 

status: (text) 

29. Specify previous gynaecological/obstetric history of patient: (text) 

30. Specify previous gynaecological/obstetric history of partner: (text) 

31. Specify previous birth control use: (text) 

32. Specify number of previous pregnancies: (text) 

33. Specify complications of previous pregnancies: (text) 

34. Specify previous abortions and list reasons if provided: (text) 

35. Specify patient prescription drug history specific to SCI versus other: (text) 

36. Specify partner prescription drug history specific to SCI versus other: (text) 

37. Specify previous fertility treatment of patient (Note: note treatment type, duration, dose 

etc.): (text) 

D-7 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

38. Specify previous fertility treatment of partner (Note: note treatment type, duration, dose 

etc.): (text) 

39. Specify patient history of STD: (text) 

40. Specify partner history of STD: (text) 

41. Specify patient psychiatric/psychological history (e.g., depression): (text) 

42. Specify partner psychiatric/psychological history (e.g., depression): (text) 

43. Specify pre-existing cognitive impairments: (text) 

44. Specify previous patient drug and/or alcohol abuse: (text) 

45. Specify previous partner drug and/or alcohol abuse: (text) 

46. Specify patient general medical history including prior diseases, and/or conditions: (text) 

47. Specify partner general medical history including prior diseases, and/or conditions: (text) 

48. Specify other causes of infertility: (text) 

49. Concurrent conditions (list all that apply): (text) 

50. Specify the type and severity (mean; SD/SE; range: with units) of each concurrent

condition, as well as how it was defined and diagnosed: (text) 

51. Specify the percentage/proportion of the whole sample re each type of each concurrent 

condition: (text) 

52. Comments, including notable differences between study arms/cohorts re concurrent 

conditions: (text) 

53. Specify pre-study medications or treatments for each concurrent condition, with 

dose/frequency: (text) 

54. Comments, including notable differences between study arms / cohorts re pre-study 

medication(s) or treatments, including dose/frequency: (text) 

55. Specify cause of spinal cord injury: (text) 

56. Specify the level of spinal cord injury: (text) 

57. Specify ASIA Level: (text) 

58. Specify duration since spinal cord injury: (text) 

59. Please list general comments, including notable differences between arms/cohorts re 

participants' baseline control of condition? (e.g., do any red flags stand out between the 

groups?): (text) 

60. List of study’s inclusion criteria: (text) 

61. List of study’s exclusion criteria: (text) 

62. Intention of study (select all that apply) (check) 

63. Type of study (select one): (mult) 

64. Data were analyzed according to which criterion (select one)? (mult) 

65. If you answered ‘Other’ to the preceding question, specify: 

66. Study duration, including units (includes run-in period protocol/duration, washout 

protocol/duration, etc.): (text) 

67. Specify product name used for pharmacologic, device and/or other intervention(s): (text) 

Specify name of manufacturer of pharmacologic, device or other intervention product: 

(text) 

68. Medications allowed or mandated during the study (dose/ frequency): (text) 

69. Comments, including notable differences between study arms/ cohorts re participants’ 

medication: (text) 

70. Concurrent therapies (e.g., physiotherapy; occupational therapy; chiropractic; counseling 

etc.) allowed or mandated during the study (intensity; frequency; duration): (text) 

D-8 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

71. Comments, including notable differences between study arms/ cohorts re participants’ 

concurrent therapies: (text) 

72. Permitted or required medications or treatments for concurrent conditions (specify dose/ 

frequency, and for which concurrent condition): (text) 

73. Outcomes assessed (e.g. efficacy, incidence, prevalence, etc): (text) 

74. Timing of outcome assessments and when, relative to start of intervention (e.g. at week 

4): (text) 

75. Number of study arm/ cohorts (note: in a cross-over trial, each different phase is 

considered an exposure / intervention arm): (text) 

76. Define the study arms or cohorts of interest to the present review: (text) 

77. Study arm number: (text) 

78. Sample size at study entry: (text) 

79. Sample size of those who completed the study: (text) 

80. Intervention length (weeks, months): (text) 

81. Arm type (placebo, active, control): (text) 

82. Intervention/ exposure type (e.g. drug or placebo): (text) 

83. Dose / frequency: (text) 

84. Timing (AM, PM): (text) 

85. Study arm number (Click here if there is no more arm/cohort): (text) 

86. Sample size at study entry: (text) 

87. Sample size of those who completed the study: (text) 

88. Intervention length (weeks, months): (text) 

89. Arm type (placebo, active, control): (text) 

90. Intervention/ exposure type (e.g. drug or placebo): (text) 

91. Dose / frequency: (text 

92. Timing (AM, PM): (text) 

93. Study arm number (Click here if there is no more arm/cohort): (text) 

94. Sample size at study entry: (text) 

95. Sample size of those who completed the study: (text) 

96. Intervention length (weeks, months): (text) 

97. Arm type (placebo, active, control): (text) 

98. Intervention/ exposure type (e.g. drug or placebo): (text) 

99. Dose / frequency: (text) 

100. Timing (AM, PM): (text) 

101. Study arm number (Click here if there is no more arm/cohort): (text) 

102. Sample size at study entry: (text) 

103. Sample size of those who completed the study: (text) 

104. Intervention length (weeks, months): (text) 

105. Arm type (placebo, active, control): (text) 

106. Intervention/ exposure type (e.g. drug or placebo): (text) 

107. Dose / frequency: (text) 

108. Timing (AM, PM): (text) 

109. Seminal parameters (e.g., specify ejaculation volume; sperm concentration; sperm

motility; morphology): (text) 

110. Ejaculation rates (frequency): (text) 

111. Cycle function: (text) 

D-9 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

112. Ovulation rates (e.g., specify total # of ovulatory cycles of the female partner; state the 

# of cycles with fertilization; state the # of pregnancy rates per treatment cycle): (text) 

113. Pregnancy rates (specify # reported): ( 

114. Miscarriage/ectopic pregnancy rates (genetic or other): (text) 

115. Induced Abortion(s) (genetic or other): (text) 

116. Live births (e.g., # of births and if singletons, twins or higher order): (text) 

117. Psychological (e.g., sexual functioning questionnaires; depression scale & scores): 

(text) 

118. Genetic abnormalities: (text) 

119. Infection rates: (text) 

120. Divorce: (text) 

121. Additional Outcomes Not Covered Above: 

122. Other(s): (text) 

123. Specify Follow-up(s) (length; duration & results): (text) 

124. Adverse events/ side effects reported in the present study (including local (e.g., 

infection); systemic (e.g., hypotension, death, etc.); 

125. Other (e.g., psychological etc.) per study arm/cohort: (text) 

126. General Study Comments (Identify any problems with the research design (e.g., 

definition of placebo/control(s); inappropriateness of run-in and washout periods), or its 

implementation): (text) 

D-10 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Quality Assessment Forms—RCTs 

Jadad Scale 

Descriptor Yes No

Was the study described as randomized (this includes the use of words such 

as randomly, random, and randomization)? 

The method used to generate the sequence of randomization was described 

and it was appropriate (table of random numbers, computer generated, etc) 

Was the report of allocation 

concealment: 

Adequate 1 Inadequate 1 Unclear 1

Was the study described as double blind? 

The method of double blinding was described and it was appropriate

(identical placebo, active placebo, dummy, etc)? 

Was there a description of withdrawals and dropouts? 

Allocation Concealment 

Refers to the technique used to implement the randomization sequence, not to generate it. 

Adequate 

• Sequentially numbered, opaque, sealed envelopes (SNOSE) 

• Pharmacy controlled 

• Numbered or ordered containers 

• Central randomization – for example by telephone to a trials office or other method 

whose description contained elements convincing of concealment – for example a secure 

computer assisted method. 

Inadequate 

• Alternation 

• Reference to case record numbers or to dates of birth 

Unclear 

• No mention of an allocation concealment approach at all 

• An approach that does not fall into either adequate or inadequate allocation concealment 

D-11 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Quality Assessment Forms—Case-Control and Cohort 

Studies 

Newcastle-Ottawa Scale (NOS) 

Descriptor Yes No Can’t tell

Was the therapeutic intervention reported? 

Were the inclusion/exclusion criteria reported? 

Was follow-up reported as an inclusion criterion? 

Was the sample size determination reported (cases accrued consecutively

or non consecutively over a specified time period)?

Were the sample size calculations (and any assumptions) reported? 

Was the time period for accrual of cases and whether they were 

accumulated prospectively or retrospectively reported?

Were the sources of participants (same or different clinicians, one or more

center) reported? 

Were how the outcome assessments made and who made them reported? 

Was blinding reported? 

Were the primary and secondary measures reported? 

Was the timing of the outcome measures reported? 

Was a follow-up schedule reported?

Were efforts used to maintain follow-up with participants reported? 

Did the authors report on compliance with follow-up? 

Was the method of data collection reported? 

Were any participant exclusions from data analysis reported? 

Was the statistical approach for analyzing the data reported? 

Did the authors report any missing data and how it was handled in the 

data analysis? 

Did the authors report any adverse events?

D-12 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Quality Assessment Forms—Noncomparative Case-Series 

Studies 

Quality assessment yes partial no n/a

1. Question / objective sufficiently described?

2. Design evident and appropriate to answer study question?

3. Subject characteristics sufficiently described?

4. Subjects appropriate to the study question? 

5. Controls used and appropriate? (if no control, check no)

6. Method of subject selection described and appropriate? 

7. If random allocation to treatment groups was possible, is it 

described? (if not possible, check n/a) 

8. If blinding of investigators to intervention was possible, is it 

reported? (If not possible, n/a) 

9. If blinding of subjects to intervention was possible, is it reported? 

(If not possible, n/a)1

10. Outcome measure well defined and robust to measurement bias?

Means of assessment reported?

11. Confounding accounted for? 

12. Sample size adequate? 

13. Post hoc power calculations or confidence intervals reported for 

statistically non significant results?

14. Statistical analyses appropriate?

15. Statistical tests stated?

16. Exact p-values or confidence intervals stated?

17. Attrition of subjects and reason for attrition recorded? 

18. Results reported in sufficient detail? 

19. Do the results support the conclusions? 

Sum (items 1-19) 

D-13 
Appendix D. Data Assessment and Data Abstraction Forms (continued) 

Quality Assessment Forms—Abstracts 

Abstract (conference proceeding) quality assessment

Study design 

Human 

interventional:

• parallel controlled trial 1

• Randomization reported? 1

• cross over trial 1

• time series trial (before-after) 1

• non-concurrent / historic controls 1

• natural experiment 1

observational:

• cohort, prospective 1

• cohort, retrospective 1

• cross-sectional 1

• case-control 1

descript., case report/series 1

D-14 
Appendix E. Evidence Tables 

Appendix E. Evidence Tables 

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacological/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-u

Bensman 

1966, US 

(Ref ID 

1627) 

• Enrolled/ evaluated: 

N=5/N=5 

• % males: 100%• Race/ethnicity: NR • Age: 24.2 (21-32) y• Level of Injury: C4-

L2 

• ASIA Level: NR • Duration since 

injury: (0.5-13) y 

• Previous fertility: 

NR 

• Drop-outs: n=0 • Lost in follow-up: 

n=0 

• Number of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: 4/19 (+) reported 

• Pharmacologic: NR• Device: Electrostimulator(n=5) • Amplitude: sin current of 20-30 mA • Frequency: 2-10 cycle/m • Mode/Admin. Route: rectal probe; duration of 

ES maintained for 5-10 m

• Other Device: NR• Surgical: NR• Procedure: NR• Bladder catheterization • -with/without alkalinization: not performed, 

urine acidic in all cases post ES 

• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR

• Behavioural: NR

• Laboratory techniques: NR

• Outcomes: • Seminal Parameters

sperm obtained in 3/pts; 1st pt SpC 410K 

sperm/ cm4 and 20-30% of sperm abnorforms; 2nd pt SpC 1mln sperm/ cm4, all non-motile; 3rd pt 14sperm/cm4 obtained 

• EJ Rates: 0/5 AG; 3/

RG

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

retrograde; BP = blood pressure 

E-1
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (continued) 

E-2

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w

Beretta, 

1989, 

Italy

(Ref ID 

695)

• Enrolled/evaluated

: n=102/n=102

• % males: 100%• Race/ethnicity: NR • Age: 25.6 (NR) y• Level of Injury: 

(n=17) Cervical 7 complete, 10 Incomplete; (n=41) T1-T10 (22 complete, 19 Incomplete); (n=21) T11-L1; (n=15) L2-L5 3complete, 12 Incomplete; (n=8) Sacral, 3 complete, 5 incomplete 

• ASIA Level: NR • Duration since 

injury: 6.1 y 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS • Duration: 3 mo 

• Eligi

bility Criteria: 

• Inclusion: No 

secondaryneurological sequelae, empty & not irritated rectum & bladder; (-) urine cultures; T12, L1 & L2 myelomeres must be intact 

• Exclusion: NR • Quality Assessment:

11/19 (+) reported

• Pharmacolo

gic: NR 

• De

vice: vibrator Le Vibrion 

• Amplitude: NR• Frequency: 100 VS/ sec • Mode/Admin. Route: applied to penile 

surface for 10 m, some pts used vibrator at home 

• Surgical: (n=6) couples: • Penile Implants • Proc

edural: NR

• Beha

vioural: NR 

• Laboratory techniques (n=6): AHI • If sperm quality good, female partners 

under

went fertility investigations, prolactin 

& progesterone assays in 2nd phase of menstrual cycle & cervical score determination. Homologous intracervical insemination performed during ovulation. 

• Intrauterine insemination: NR• IVF: NR • Intracytoplasmic sperm injection: NR • Embryo cryopreservation: NR• Sperm cryopreservation: NR - ejaculated  -biopsy 

• Outcomes: • Measures of Fertility Ra• Seminal Parameters: S 

in sperm concentration mo (p< 0.05) 

with no co

to increase in vol. S decabnormal sperm (% of mand morphology P<0.0increase in sperm conc(p<0.05), no increase in S increase in motility (p

• EJ Rates: Total EJs =78

68, RG = 20 

• Pregnancy rates: (n=3) • Follo

w-up: (n=15) 

• Length: 

weekly follo

w-u

• Duration: NR • Results: abnormal sper

steeple decreased over 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R

insemination from husband; BP = blood pressure 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-3

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-

Beretta, 

1987, 

Italy

(Ref ID 

984) 

• Enrolled/ 

evaluated: n=142/n=142 

• % males: 100%• Race/ethnicity: NR • Age: 26.1 (NR) y• Level of Injury: 

n=79 > T11; n=48 thoraco-lumbar; n=15 sacral; n=59 complete & 83 incomplete 

• ASIA Level: NR • Duration since 

injury: mean 5.9 y

• Previous fertility: 

NR 

• Drop-outs: NR • Lost to follow-up: 

NR 

• Number of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR 

• Eligibility Criteria: • Inclusion: no 

secondary neurologysequelae; empty & non-irritated rectum & bladder; negative urine cultures; no lesions of D12, L1, L2 

• Exclusion: NR • Quality

Assessment: 5/19 (+) reported

• Pharmacologic: NR • Device: Vibrator (n=142) 

• Amplitude: 30 Watts; 220 V • Frequency: 100Hz • Mode/Admin. Route: VS applied to penile 

surface for 10 m, wkly for 3 m 

• Other Device: NR 

• Surgical: NR • Procedure: NR

• Behavioural: NR 

• Laboratory techniques (n=21): • Donor sperm insemination: NR • Sperm preparation: NR • Intrauterine insemination: NR• IVF: in 3/4 which resulted in pregnancy/ 

1/4 used auto-insemination 

• Intracytoplasmic sperm injection: NR • Embryo cryopreservation: NR• Sperm cryopreservation: NR

• Outcomes: • EJ Rates: 99/142(69.7%• Pregnancy rates: 4/21(1• Follow-up: (n=2) • Length: NR • Duration: 3 m • Results: before /after tx 

study of seminal paramepts: S increase in sperm concentration(p<0.05); n

semen volume; S decreaabnormal spermatozoa (S (+) increase in motility morphologic features ov(p<0.01) 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-4

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Fo

Brackett, 

1995, US 

(Ref ID 

572) 

• Enrolled/ evaluated: 

23 SCI couples; 2 other couples 1 MS, 1 transverse myilitis/ n=23 couples 

• % males: 50% of 

couples 

• Race/ethnicity: NR • Age: SCI men 

35.2±1.1; 26-42 y;female pts, 24-42 y,

• Level of Injury: 

cervical in 7; thoracic in 12; lumbar in 2 

• ASIA Level: NR • Duration since injury: 

13.1 (5-28) y

• Previous fertility: NR • Drop-outs: n=0 • Lost to follo

w-up: n=0 

• Number of sites: 1 • Funding: Partially

supported by NLB from the MiamiProject to Cure Paralysis 

• Study Design:

NCS 

• Duration: May

1991-Sep 1994, retrospective study 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent:

10/19 (+) reported 

• Pharmacolo

gic: NR 

• De

vice: Oster Model 129-01A (n = 4) 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: mean time of stimulating 

frenulum until EJ, 2.5±0.7 m 

• Oth

er De

vice (n = 19): Electrostimulator/ 

• Amplitude/voltage: 1 to max of 8V • Mode/Admin: anesthesia/ general anesthesia in 5 

(4/5 SCI pts) 

• Surgical: NR 

• Proc

edure (n=23): 

• Bladder catheterization • -with/

without alkalinization: sodium bicarbonate 

(20 g /6 hrs for 72 hrs) pre VS /ES 

• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR • Beha

vioural: NR 

• Laboratory techniques (in 23 SCI couples):• Donor sperm insemination: NR • Sperm preparation: by all techniques in n=22-

swim-up 

• Intrauterine insemination: 60 cycles of IUI in 22 

couples 

with clomiplene Citrate (50-100 mg/d, 

orally for 5 ds)/ gondotropins (hMZG &/or F

SH, 75-

225IU/d, i.m.) 

• IVF/GIFT: IVF-ET in n=6 

with embryo transfer @ 

48 hr post retrieval; GIFT in n=4 

with laparascopic 

gamete transfer 

• Intracytoplasmic sperm injection: NR • Embryo cryopreservation: NR

• Outco

mes: 

• Measures of Fe

Rates: 13/22 conceptions 

• Seminal Param

normal sperm concentration (mln/cc) but poo(12.6± 1.1

%); S

within normal le(50.2± 6.9

%); a

measures lo

we

vs. AG; NS dfs parameters of Sother pts 

• Cycle Function

females had 52clomiphene citrof them had 8 covulation induchMG and /or F

S

• Pregnancy rate

IVF; 27% in IUI11/22 

• Miscarriage/ect

case, medically 

• Induced abortio

spontaneous abin pt 

with 3 preg

• Live Births: 8/2• Singletons: 8/2• Foll

o

w-up: NR

SCI = spinal cord injury; MS = multiple sclerosis; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = mon

hours; ctrl = control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = mic= millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of pqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG 

IUI = intra-uterine insemination
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-5

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-u

Brackett, 

1997, US 

(Ref ID 

308) 

• Enrolled/ evaluated: 

n=77/ n=77 

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: 45% 

cervical; 51% thoracic; 4% lumbar; 39% quadriplegic (allincomplete0; 61% paraplegic (43%complete) 

• ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Drop-outs: NR • Lost to follo

w-up: NR 

• Number of sites: 1 • Funding: grant from 

Miami Project to Cure Paralysis & State of Florida SpecificAppropriation No. 224 for Spinal CordResearch 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent:

8/19 (+) reported 

• Pharmacolo

gic: NR 

• De

vice: Sunbeam Model 1850-1 Vibrator 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: 5 m VS & 1 m rest 

then resumed for 5 m; 1-3 trials of VS/ pt then assigned to 1/3 grps: VS only, ES only or VS+ES 

• Oth

er De

vice: Electrical stimulator 

• Type: Seager Model 14 • Mode/Admin. Route: NR • Surgical: NR 

• Proc

edure:

• Bladder catheterization • -with/

without alkalinization: 41% 

intermittent catheterization, 36% external catheter, 14% voluntary voiding, & 8% suprapubic & 1

% Foley catheter 

• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR • Beha

vioural: NR 

• Laboratory techniques: NR

• Outco

mes: 

• Seminal Parameters: no 

SpC of vs. ES (155.0± 4mln vs. 191.3± 50.0mln)AG, S greater SpC 

with 

(141.7± 24.4 mln vs. 89.11.6 mln); in R

G mean S

greater in ES vs. VS (95vs. 38.1±6.3); mean percmotile sperm greater in v(18.5±2.5 vs. 10.1± 1.5%mean % of sperm 

with ra

linear motion in VS S > vES in total ejaculate (12.vs. 5.7± 1.0%) & RG frac(13.6± 1.3 vs. 6.2± 0.7%within pt comparisons of revealed NS 

∆ in total S

total EJ or AG or RG frabet

ween speci

mens obta

with 2 methods 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

retrograde 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-6

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-

Brackett 

2000, US 

(Ref ID 

950)

• Enrolled/ evaluated: 

n=26; n=12 SCI, n=14 ctrl/n=26

• % males: 100%• Race/ethnicity: NR • Age: SCI 37 (NR) y;

ctrl 34.9 (20-40) y

• Level of Injury: C4-

L1 (n=9) data missing in (n=3) SCI 

• ASIA Level: NR • Duration since 

injury: 14.6 (5-23) y

• Previous fertility: 

NR 

• Dropouts: n=5 • Lost in follo

w-up: 

n=20 

• N of sites: 1 • Funding: NIH: Grant 

State of FloridaSpecific Appropriations & the Miami Project to Cure Paralysis

• Study Design:

NCS 

• Duration: 3 mo 

• Eligi

bility

Criteria: 

• Inclusion: No 

secondaryneurological sequel, empty & not irritated rectum & bladder, negative urine culture, T12 & L1 & L2 myelomeres must be intact 

• Exclusion: NR • Quality

Assessm

ent: 7* 

(NOS)

• Pharmacolo

gic (n = x): NR

• De

vice: (Vibrator Le Vibrion) (n = 8)

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR • Other De

vice (n = 8): 

• Type 

Electroejaculator 

• Manufacturer: NR • Surgical: NR 

• Proc

edure: NR 

• Beha

vioural (n = 14): 

• masturbation in ctrl grp to obtain specimen• Laboratory techniques: (n = 26): • Donor sperm insemination: NR • Sperm preparation (vas deferens 

aspiration): Sperm removed by aspiration of vas deferens of normal ctrls (12/14) during standard vasectomy during local anesthesia. Epididymis milked & vas divided vas then lavaged & aspirated 

with 

0.1 to 0.2 ml of sterile sperm bufferingsolution in 5 mg/ml Vas aspiration in SCI pts (9/12) obtained after anesthesia & hemisectioned mirosurgically. Cannulation, lavage & aspiration performed as in ctrls. Vas aspiration specimen then compared 

with AG EJ 

obtained from both grps. 

• Outco

mes: 

• Measures of Fertility Rat• Seminal Parameters: % o

& viable sperm in vas as(VAS) vs. ejaculated spe(EJ): S df bet

ween VAS 

ctrls (p < 0.001), S bet

we

SCI < ctrls (p < 0.0001), bet

ween VAS > EJ in SC

0.0001), NS df bet

ween 

EJ of ctrls 

• Sperm viability: S df bet

w

VAS of SCI < VAS of ctr(p<0.02), S df bet

ween E

< EJ of ctrl (p < 0.0001), bet

ween VAS > EJ in SC

<0.0001). 

• Foll

o

w u

p: EJ in (n=6) S

mo after vas aspiration rsperm parameters similaejaculates before aspirat

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

retrograde; NIH = National Institute of Health
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-7

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-up

Brindle

y, 

1981, UK 

(Ref ID 

1830)

• Enrolled/ evaluated: 

n=37/ n=37 

• % males: 100%• Race/ethnicity: NR • Age: NR 

• Level of Injury: 

lesions belo

w, at or 

above L2. 

• ASIA Level: NR 

• Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: 

NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 2/19 

(+) reported 

• Pharmacolo

gic (n=x): NR

• De

vice: Electrostimulator (n =37)

• Amplitude: NR• Frequency: Sinusoidal current of 

15-35 Hz, or rectangular pulse for duration of 100 microseconds,resistant of 40 

Ω on, 72-99 V for 

up to 30 sec. 

• Admin. Site: Obturator nerve • Oth

er De

vice: NR

• Surgical: NR 

• Proc

edure: NR

• Beha

vioural: NR

• Laboratory techniques: NR 

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: Some motile 

spermatozoa seen in semen of 14/15 AG, & in urine of 2/9 RG. Motile spermatozoa range from 02.5 per mlns in (n=10), 2.5-5 in(n=2), 5-10 in (n=3), 10-20 in (n=20-40 in (n=4), 40-80 in (n=5), & 80-100 in (n=2). Semen resulting pregnancy in one 30 y old compleT6 contained 200 mlns spermatozoa per ml 

with 1% 

motility.

• EJ Rates: AG EJ=12 on 1st attem

2 on 2nd & 1 on 3rd; RG EJ = 7 on 

1st attempt & 2 on 2nd. No sperm 

(n=7), 3 of them failed to produce urine specimen; in 4 of these semen contained no spermatozoa

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

= retrograde 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-8

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-up

Brindle

y, 

1981, UK 

(Ref ID 

801)

• Enrolled/ evaluated: 

n=178: n=175 SCI; n=5 other/ n=

N

R

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: n=22 

C6-T1; n=50 

T2-T12; 

n=12 L1 or below; (n=17 incomplete, n=14 flaccid, n=53 complete) 

• ASIA Level: NR

• Duration since injury: 

NR 

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 5/19 

(+) reported 

• Pharmacolo

gic (n = x): NR

• De

vice: Electrostimulator 

(n=89) 

• A

mplitude: Peak voltage up 

to 108v 

• Frequency: frequency of 

pulse 30, 15, 10 per sec, time bet

ween pulses 10ms

• Mode/A

d

min. Route: NR

• Oth

er De

vice: NR

• Surgical: NR

• Proc

edure: NR

• Beha

vioural: NR

• Laboratory techniques: NR

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: • EJ Rates: In SCI pts 

external success in EEJ (n=36); RG success (n=14); Definite failure: (n=32) 

• In 7 pts electro stimulation 

intolerably painful. 

• Correlates of failure: In 9 of 

20 definite failures EEJ seemed to have its proper effect on prostate, seminal vesicles, & vasa deferntia, but pts azoospermic from disease or injury of upper genital tract. 

• Foll

o

w-up: NR

• A/

E

• Loca

striaconmuswith& in 1/44 con4 ptspaless Mic& seErebut ConmusSCI lesio

• Sys

pres

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

sperm count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fe

antegrade; RG = retrograde; EEJ = electro ejaculation; BP = blood pressure 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-9

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/F

Brindley, 

1984, UK 

(Ref ID 

756)

• Enrolled/ evaluated: 

n=81/n=81 

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: 5-L1 or 

below

• ASIA Level: NR

• Duration since injury: 

(n=28) < 6 mo, (n=126) > 6 mo

• Previous fertility: None • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: 6/19 (+) 

reported 

• Pharmacologic: NR• Device: The Ling 201 Vibrator

(n=81) 

• Amplitude: about 2.5mm • Frequency: 80Hz • Mode/Admin. Route: NR 

• Other Device: NR• Surgical: NR• Procedure: NR• Behavioural: NR

• Laboratory techniques: NR 

• Outcomes:

• Measures of Fer• EJ Rates: (n=15

T1 there 23 AG, external failure, (n=43); in SCI T18 RG, 20 definexternal failure, prevented EJ (toL1 or below, 6 Adefinite failure, 1 failure & in 15 paEJ (total n=23). 

• With regard to t

injury, in pts with post injury 14 AGdefinite failure, 5 failure, & in 4 paEJ (n=28); in SCAG, 26 RG, 27 d5 external failureprevented EJ. 

• Pregnancy rates• Live Births: n=9 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-u

Brindle

y

1986, UK

(Ref ID 

729)

• Enrolled/evaluated: 

n=12/ n=12 

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: all 

paraplegic pts 

• ASIA Level: NR • Duration since 

injury: 0-10 y 

• Previous fertility: 

n=7 azospermia due to obstruction of abdominal part of vas deferens; n=2 cystectomy; n=1 ejaculatory cyst; n=1 imperforate anus, n=1 Panproctocolectomy; n=1 Tuberculosis, n=1bladder exstrophy 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: 36 mo • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 6/19 

(+) reported 

• Pharmacolo

gic: NR 

• De

vice: NR

• Surgical (n=12): Sperm Reservoir 

Implanted Sperm Reservoir for Obstructive (alumina & glass silicone rubber) 

• Technique: inserted via inguinal incisions.

Prophylactic antibiotics given for 7d 

• Beha

vioural: NR

• Laboratory techniques (n=12)• AIH: pts injected tissue culture medium into 

reservoirs & either provokes orgasm (SCI) or 

wait 1 h. Reaspiration yielded a mixture 

or culture & presumable fresh spermatozoa. 

• Outco

mes:

• Measures of Fertility

Rates: 

• Seminal Parameters: 

Sperm retrieval from rreservoir in paras: vol=0.2-1.0, Count=20140, Motility=0-30%. Retrieval from left reservoir in paras: Vol=0.2- 0.8, Count=0Motility=0-1%,

• Sperm Retrieval from p

with vasal obstruction, right reservoir: Vol=0.10.8, Count=0-233, Motility=0-30

%; Left 

reservoir, Vol=0. 2-0.6Count=0-30, Motility=030% 

• Pregnancy rates: (n=2

(17%) 

• Live Births: (n=2) • Singletons: (n=2) 

• Foll

o

w-up:

• Length: monthly chec• Duration: 

• Results: aspirates 

examined microscopicUpon identification of motile spermatozoa, instruction in artificial insemination given. 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

= retrograde; AIH = artificial insemination from husband

E-10
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d)

E-11

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w

Brinsden, 

1997, UK 

(Ref ID 

528) 

• Enrolled/ evaluated: 

n=35 couples/ n=35 couples 

• % male: 50% • Race/ethnicity: NR • Age: male 32.2 (24-

47) y; female partner 29.4 (21-43) y 

• Level of Injury: C5-

L1 

• ASIA Level: NR • Duration since 

injury: 8.5 (1-27) y

• Previous fertility: 

tubal factor infertilityin 3/35 female;endometriosis in2/35 

• Dropouts: n=0 • Lost in Follow-up: 

N/A 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR • Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: other 

methods of assisted fertilization used

• Quality

Assessm

ent:

9/19 (+) reported 

• Pharmacolo

gic: NR

• De

vice: electrical stimulator/ Vibrator 

• Amplitude/Frequency: NR 

• Laboratory techniques:

• AG: a t

wo-step Percoll gradient, & 

resuspention in Earle’s culturemedium. Sperm concentrationadjusted to 100 000/ml 

• RG: centrifuged at 200 g for 5 m 

resuspended in Earle’s culture medium & centrifugation repeated. 

• Intrauterine insemination: NR• IVF: 71 cycle of IVF obtained by

T

REE. N of cycles to oocyte recover 

(%) 67(94.4); n of couples 

with

complete failure of fertilization (%), 9 (13.4); n of embryo transfers cancelled: 2; n of fresh embryo transfer cycles: 54; n of fresh embryos transferred/cycle mean: 2.4; n of cycles 

with spare embryos 

cryopreserved (%): 22/54(40.7); n of spare embryos cryoprederved mean: 2.70. 

• Intracytoplasmic sperm injection • Embryo cryopreservation: n of 

couples with cryopreserve embryos: (n

=11), n

of thawed embryo tran

sfer

cycles 14, n of embryos transferred mean: 2.3; n of clinical pregnancies/ transfer (%): 4(28.6), n of live births / couple with frozen embryos (%), 4(36.4)

• Outco

mes:

• Measures of Fertility Rates

•Seminal Parameters: when 

occurre

d, initial mean tota

mln/ml; Initial mean total m5.3 mln/ml; Initial mean moPost sperm preparation mmln/ml; mean motility 65%to acolyte recovery 67/71 (

• Pregnancy rates: 18 total; (n=

embryo transfers; (n=4) frozetransfers; n of total delivered pregnancies 14; pregnancy rastarted: 21.2% (18/85); Clinicrate per couple 51.4% (18/35

• Miscarriage/ectopic: (n=4) (3 

trimester, 1 in a second trime

• Live Births: (n=14) • Singletons: (n=13) • Multiples: 5 diagnosed as t

wi

ultrasound, 2 of which deliverbabies 

• A

dditional Outcomes: Over

pregnancy rate per stimulatestarted 25.4

% (18/71); Overa

pregnancy rate per fresh em25.9% (14/54); Overall clinicarate per frozen-tha

wed embr

cycle 28.6

% (4/14) 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-12

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-

Buch, 

1993, US 

(Ref ID 

624)

• Enrolled/evaluated: 

n=18/ n=18 

• % males: 100%• Race/ethnicity: NR • Age: 31 (22-43) y• Level of Injury: 

Cervical C5-C6:7,Thoracic T3-T12: 11(ASIA scores: A 12; B-D 6) 

• ASIA Level: NR • Duration since 

injury: 8.8 (2-22) y

• Previous fertility: 

NR 

• Dropouts: n=2 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: Paralyzed 

Veterans of American Spinal Cord InjuryResearch Foundation 

• Study Design:

NCS 

• Duration: 2.5 

• Eligi

bility Criteria: 

• Inclusion: men 

older than 19 Y with SCI for fertilityevaluation 

• Exclusion: NR • Quality

Assessm

ent: 8/19 

(+) reported 

• Pharmacolo

gic:

• Drug name nifedipine (tx of hypertension) • Dose: 5-10 mg • Duration: NR • Schedule: at each session • Mode/Admin. Route: Sublingual (5-10 m 

pre-s

wallowing) 

• De

vice: rectal probe for EJ

• Amplitude: up to 600 mA • Frequency: 60 Hz • Mode/Admin. Route: NR 

• Oth

er De

vice: NR 

• Surgical: NR• Proc

edure:

• Bladder catheterization -with/

without alkalinization: Oral sodium 

bicarbonate 36 hr pre-tx (alkalization of urine)/Oral antibiotics 7-10 d pre-tx 

• protoscopy: ruling out rectal injury pre EEJ • Beha

vioural: NR 

• Laboratory techniques:• Sperm preparation: Std analysis on AG & 

RG specimens. (RG centrifuged @ 600 times gravity for 10 m, aspirated & resuspended over volume of 1-4ml. Bigger’s Whitten & Wittingham solutionthen mixed 

with AG, frozen & tha

wed. 

• intrauterine insemination: in all couples; 2-

4 cycles; 

with or without oral clomipene, 

nest 3 cycles 

with human menopausal 

gonadotropin ovarian stimulation & progress to IVF if IUI failed 

Outco

mes: 

• Measures of Fertility Rate• Seminal Parameters: ave

total SpC in both RG & A304 mln/ml; average totaSpC 83 mln/ml; average motile sperm 21% 

• EJ Rates: total 89%; in 

quadriplegics 100% (7/7) paraplegics 82% (9/11) 

• Pregnancy rates: 50% (3

woman got pregnant t

wic

• Live Births: n=2 

•Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-

Le

Chapelain

1998, 

France 

(Ref ID 

522) 

• Enrolled/ 

evaluated: n=39/ n=10 evaluated for conception 

• % males: 100%

of 39 SCI; 50%of 10 couples 

• Race/ethnicity:

NR 

• Age: 28.5 (19-

49) Y 

• Level of Injury: 

17 tetraplagics C4-8 (8 complete, 9 incomplete); 15paraplegic T1-T10 (all complete); 7 paraplegic pts T11-L2 (complete or incomplete) 

• Study Design:

NCS 

• Duration: 5 yr

retrospective study 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent:

11/19 (+) reported 

• Pharmacologic (n = 9): 

• Drug name: physostigmine • Dose: 2mg • Duration: NR • Schedule: 10 m post administration of 

Metoclopramide (10mg) 

• Mode/Admin. Route: injection of 

physostigmine follo

wed by VS 10-15 m later 

• De

vice: Vibrion Vibrator (n=18) 

• Amplitude: 2-4.5 mm • Frequency: 100 Hz • Mode/Admin. Route: 3 m VS follo

wed by 1 m 

pause for max of 3 cycles/session 

• Other Device: Electrostimulator 

(Stimed)(n=19) 

• Frequency: 50 Hz • Intensity: 125 mA • Duration: up to 10 m/session • Note: at least 2 distinct sessions 

with

physostigmine/ VS or ES attempts conducted for each pt. 

• Surgical: NR • Proc

edure: NR

• Outco

mes: 

• Measures of Fertility Ra• Seminal Parameters: m

volume of sperm obtainVS S higher (p=0.0136that of ES; % motile forhigher in vs. ES (p=0.0NS in number of sperm& % of normal form in v

• EJ Rates: 30/39 (77%) 

ejaculated

• 12/18 (68%) ejaculated 

VS; rate of success 86tetraplegic grp, 62% in paraplegic subgrp, & 33T11-L2 subgrp

• 13/19 (68%) 

with ES 

ejaculated; rate of succ83% in tetraplegic grp, T1-T10 grp & 50% in Tgrp 

• 6/9 (66%) ejaculated w

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

= retrograde 

E-13
Appendix E. Evidence Tables (continued)

E-14

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Le

Chapelain

1998, 

France 

(cont’d) 

(Ref ID 

522)

• ASIA Level: NR • Duration since 

injury: NR 

• Previous fertility: 

NR 

• Drop-outs: n=0 • Lost to follow-up: 

NR 

• Number of sites: 

1 

• Funding: NR 

• See above. • Bladder catheterization: 

• without alkalinization after tx• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR • Behavioural: NR• Laboratory techniques:• Donor sperm insemination: NR • Sperm preparation: NR • Intrauterine insemination: n=3• IVF: in one couple reported • Intracytoplasmic sperm injection: NR • Embryo cryopreservation: NR• Sperm cryopreservation: NR 

• physostigmine injec

rate of success 100tetraplegic grp, 33% T10 grp & 0% in T1

• Pregnancy rates: 3/• Miscarriage/ectopic

spontaneous 

• Live Births: 2/10• Singletons: 2/10• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

= retrograde 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-15

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-

Chapelle, 

1983, 

France 

(Ref ID 

1404)

• Enrolled/ evaluated 

n=20/ n=20 

• % males:100%• Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since 

injury: NR 

• Previous fertility: NR • Dropouts: NR • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR • Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment:

8/19 (+) reported 

• Pharmacologic (n =20):

• Drug name intervention: PSC

injection, ISN 

• Dose: Baseline: PCS - 4 mg, 

average 2 mg 30 m after Nbuthylhyocine 40 mg followed bymasturbation 15 m later several wks ISN (following lumbar puncture) 0.25 or 0.5 mg mixed with cerebrospinal fluid, injected intrathecally. (Some pts received a supplementary injection of 1 mg PCS when noresults obtained from first injection 30 m later.

• Duration: NR 

• Schedule: NR • Mode/Admin. Route: injection of 

PSC or ISN test not performed if lesion affected T12, L1 or L2 & PSC test negative 

• Device: NR

• Other Device: NR

• Surgical: NR • Procedure: NR• Behavioural (n = 20): 

• Type: masturbation • Duration: NR • Frequency: 15 m post-injection• Laboratory techniques: NR

• Outcomes: 

• Measures of Fertility Rate• Erectile function: erectio

to obtain & maintain aftetest. Erection not affecteof cases when PSC negaimproved in 40%. When positive, erection improv80% of cases. indication & ISN are identical but lapresents fewer disadvan

• Follow-up: 

• Pts used PSC at home w

any medical supervision had experimented & resto their test in hospital. 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

ISN = intrathecal neostigmine
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-16

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-

Chen, 

1997, US 

(Ref ID 

2069) 

• Enrolled/ evaluated: 

n=14/ n=14 

• % males: 100%• Race/ethnicity: NR • Age: 30.7 (25-41) y• Level of Injury: T6-L5 • ASIA Level: n=8 A; 

n=4 B; n=2 C 

• Duration since injury: 

6.9 y; range, 1-16 y 

• Previous fertility: NR • Drop-outs: n=0 • Lost to follow-up: n=0 • Number of sites: 1 • Funding: US Dept. of 

Education; NIDRR Research; Rehabilitation Institute of Chicago 

• Study Design: NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: < 6 ms since 

SCI 

• Quality Assessment:

10/19 (+) reported 

• Pharmacologic: NR • Device: Ling 201 Vibrator (n = 14) 

• Amplitude: 205 mm • Frequency: 80Hz • Mode/Admin. Route: VS to dorsal 

surface of penis near frenulum, in cycles of 3.5 on m-1.5 off; 

• Schedule: every 2-4 wk• Other Device: Vibrators 

• Type: panabrator; 4-in-1; Magic 

Wand; thrive Model 91 

• Manufacturer: Panasonic Industrial 

NJ; Wahl Clipper Corp, IL; Hitachi Appliance Corp, GA; Daita Electronic Co, respectively

• Surgical: NR • Procedure: NR 

• Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: • Seminal Parameters: sp

43/51(84%) AG; & in 39/61(64%) RG; SpC in (mean 74.1 mln) > RG (m40 mln) (NS); NS dfs betAG & RG in SpMot, progmotility, or normal morphwith motility being low & progressive motility beingeneral 

• EJ Rates: AG in 51/61(8

trials; AG in 1st cycle of 41/61(80%) trials; RG in of trials 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

Institute on Disability Research & Rehabilitation 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-17

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Qualit

y Assess

m

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w

Chen, 

1999, US 

(Ref ID 

952) 

• Enrolled/ evaluated: 

n=14/ n=14 

• % males: 100%• Race/ethnicity: NR • Age: 30 (25-41) y• Level of Injury: (n=8) 

Cervical, (n=6) Thoracic, n=8 Lumbar 

• ASIA Level: NR 

• Duration since injury: 

6.9 (1-16) y

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: US Dept. 

Education; NIDRR; Rehabilitation Institute of Chicago 

• Study Design: NCS • Duration: NR• Eligi

bility Criteria: 

• Inclusion: >6 m onset of SCI • Exclusion: NR • Quality Assessment: 9/19 (+) 

reported 

• Pharmacolo

gic: NR

• De

vice: Vibrator Ling 201, 

Panabrator; 4-in-1; Magic W

&; 

Thrive Model 91 (n = 14)

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: 3,5 m on & 

1.5 m off until AG ejaculate obtained or until 4 cycles completed

• Oth

er De

vice: NR

• Surgical: NR• Proc

edure: NR

• Beha

vioural: NR

• Laboratory techniques (n = 

14): Sperm preparation: Std semen analysis for semen volume, sperm concentration,count, motility, progressive SpMot, & normal SpMor. Biochemical analysis using enzdymatic EJ. 

• Outco

mes: 

• Measures of Fertility 

• Seminal Parameters

concentration: AG 81mln/ml, range 0.03-47mln/ml; SpMot: AG 37(6.7)%, range 0-60%; (30.8)%, range 0-63; progressive motility: A58.1(23.1) %, range 0RG 57.0 (37.9) %, ran100%; normal morphoAG 35.7 (11.0) %, ran52%; RG mean 31.1 (range 0-58% 

• NS bet

ween A

G & RG 

samples 

with respect 

SpMot, progressive mnormal morphology

• EJ Rates: AG EJ rate

(51/61), RG ejaculate 100% (61/61) 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

Institute on Disability & Rehabilitation Research 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Foll

Chung, 

1997, US 

(Ref ID 

547) 

• Enrolled/ evaluated: 

n=27/ n=27 

• % males: 100%• Race/ethnicity: NR • Age: (27-48) y • Level of Injury: NR • ASIA Level: NR • Duration since 

injury: NR (3-25) y

• Previous fertility: NR • Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS; 

retrospectiveobservational study 

• Duration: NR• Eligi

bility Criteria: 

• Inclusion: 

unejaculatory men with SCI or retroperitoneal LND, who treated at Rehabilitation Center at Tampa General Hospital bet

ween 

September 1991 & October 1995 

• Exclusion: NR • Quality

Assessm

ent: 9/19 

(+) reported 

• Pharmacolo

gic (n = 27): nifidepine

• Dose: 10 mg • Frequency:• Admin: 15 m pre-during & post procedure as 

prophylaxis for autonomic dysreflexia 

• De

vice: Electr

ostimulator(n

=27):

Amplitude : 2 V & increased progressively at 1- to 2-V incre

ments per stimulation every 4 

to 6 seconds until EJ occurred 

• Oth

er De

vice: NR

• Surgical: NR

• Procedure (n=x): 

• Bladder catheterization: Alkalization of urine 

with a 24-hr regimen of sodium bicarbonate before EEJ 

• Epidydimal aspiration (MESA/PESA) • Testicular biopsy

• Beha

vioural (n = x): 

• Laboratory techniques (n = 

x): 

• Sperm preparation: • Both AG & R

G

with s

wim-up technique 

• Intrauterine insemination: specimen 

washed

twice & centrifuged &resuspended in 0.2mL ofmedium, layered 

with same medium & 

incubated for 1h @ 37 ̊C & top layer collectedfor insemination 

• IVF • Intracytoplasmic sperm injection • Embryo cryopreservation • Sperm cryopreservation: -ejaculated: -biopsy 

• Outcomes: • Seminal Parameters: 

• AG (mean, SD) (n=92

0.1; volume 16.5+-2.8 64.6+-10.0 mln/ml; tot578.5+-93.6 mln/ml; m16.7%+-1.5

%; normal 

28.6%+-2.0

%

• RG (mean, SD) (n=34

0.1; volume 45.8+-6.4 8.2+-2.7 mln/ml; total 69.6 mln/ml; motility 6normal morphology 26

• EJ Rates: sperm recov

93% (86/93); solely AG 63% (59/93); combinaRG in 35% (33/93); 1 ejaculate 

• Pregnancy rates: 7 pre

13 couples 

with a tota

pregnancy rate per IU12.5% (7/56) 

• Induced abortion: 2 sp

abortions 

• Live Births: 4 term live 

going t

win pregnancy 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-18
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-19

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/F

Dahlberg, 

1995, Finland 

(Ref ID 

573) 

• Enrolled/ 

evaluated: n=63 participated forfertility tx/ 35 couples evaluated for conception

• % males: 100% of

n=63; 50% of 35 couples 

• Race/ethnicity:

NR 

• Age: NR • Level of Injury: 

NR 

• ASIA Level: NR

• Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 7/19 (+) 

reported 

• Pharmacolo

gic (n=35): 

• Drug name: S/L Nifidepine • Dose: 10-30 mg• Duration: NR • Schedule: 30 m pre-procedure • Mode/Admin. Route: sublingually• De

vice: Vibrator (n=27):

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR

• Oth

er De

vice: Electrostimulator 

(n=13) 

• Brindley’s technique / no anesthesia 

• Surgical: NR• Beha

vioural: 

• Laboratory techniques:

• Sperm preparation: s

wim-up 

technique used follo

wed by sperm 

discontinuous Percoll gradient(40/90%) 

• home insemination once per cycle • Intrauterine insemination: 4-6 cycles 

in all EEJ cases 

• IVF: 3rd choice of tx if 1st t

wo did not 

result in pregnancy; do

wn-regulation 

with intranasal buserelin acetate 1200 μg daily, started on 23rd d of previous cycle 

• Outco

mes:

• Measures of Fer• Seminal Parame

concentration bepreparation 87 m1.2-200 mln); popreparation 32 m(range .6-88 mlnmobility before p(range 2-42) & a25% (range 0-9)

• EJ Rates: EJs o

pts 

with VS & in 

RG EJ in 8 pts(sin n=2 

• Pregnancy rates• Miscarriage/ecto• Live Births: (n=2• Singletons: (n=2• Multiples: 2 sets 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/ 

other) Outcomes/Fol

de Lamirande

1995, 

Canada

(Ref ID 

960) 

• Enrolled/ evaluated: 

n=207: n=20 healthy volunteers, n=166 non-S

CI infertile, 

n=21 SCI/ n=207 

• % males: 100%• Race/ethnicity: NR • Age: SCI 28.1(20-40) 

y; healthy volunteers (n=20) NR (23-43) y,Infertile grp: NR 

• Level of Injury: n=9 

Cervical, n=12 Thoracic & Lumbar, (15 Complete, 6 incomplete) 

•ASIA Level: NR• Duration since injury: 

5.8 (0.5-14) y 

• Previous fertility: NR • Dropouts: (n=21) 

failed to respond to vibratory stimulation to ejaculate 

• Lost in follow-up: NR • N of sites: 1 • Funding: MRC,

Canada 

• Study Design:

NCS 

• Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 8/19 

(+) reported 

• Pharmacologic (19/ 21 SCI): 

• Drug/ dose: name 40 mg of 

butylbromide at time 0. 1/2 h later, 2 mg of physostigmine SC follo

wing by

semen collection (masturbation). In 2 other SCI men Nifedipine 5-10 mg sublingually pre electro stimulation to prevent Autonomic Dysreflexia

• De

vice: Electrostimulation (EEJ probe 

modes) (n = 2 SCI) 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR 

• Oth

er De

vice: NR

• Surgical: NR• Proc

edure: NR

• Beha

vioural (SCI pts): 

• Type : masturbation following injection 

of physostigmine 

• Duration: until EJ occurred• Frequency: N

R

• Laboratory techniques:• Sperm preparation: discontinuous 

Percoll gradients buffered 

with HEPESbalanced saline. 

• Reactive Oxygen Species 

Determination: ROS detected byluminescence during 10 s stirring analyzed sample following 10-fold dilution of Percollwashed spermatozoa. 

• Outcomes: 

• Seminal Parameters: S

men ranged from 0% whole semen (23/32 smeasure did not ∆ sligPercoll gradient centrisamples). In 9 of 23 spoor motility a rise in RPercoll 

washing obser

increase in ROS noted wash 

when same com

with semen with motili

• A

dditional outcomes

normal pts are lo

wer t

infertile men (p<0.05) SCI (p<0.0001). ROS infertile men compare (p<0.0001). No df in leSCI grp for level of lesof injury. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

Council; EEJ = electro ejaculation 

E-20
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-21

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-

Halstead1987, US 

(Ref ID 

986) 

• Enrolled/ evaluated: 

n=12 couples/ n=12 couples 

• % males: 50% of 12 

couple 

• Race/ethnicity: NR • Age: NR (23-38) y• Level of Injury: n=4 

C5-C6; 

n=7 T3-T12; n=1 L1 

• ASIA Level: n=7 A; 

n=1 B; n=3 C; n=1 D 

• Duration since 

injury: 5mo to 18 y 

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: • N of sites: 1 • Funding: Bob & 

Vivian Smith Foundation, Houston, & Model Rehabilitation Spinal Cord InjurySystem Grant, TIRR, funded byNational Institute of HandicappedResearch 

• Study Design: NCS

• Duration: 18 mo • Eligibility Criteria: • Inclusion: Traumatic SCI, 

age>18 y, medically stable, with preference given towards married pts. 

• Exclusion: NR • Quality Assessment:

12/19 (+) reported 

• Pharmacologic: NR• Device: (ES by rectal probe (38 

occasion in 12 SCI) 

• Amplitude: 8-15 V & 200-400 MA • Frequency: Stimulation discontinued 

if BP>200 mm HG systolic or 130 mm Hg diastolic or for any other side effects/discomfort. 

• Mode/Admin. Route: max. of 25 

stimulation/cycle (60 cycle/sec). 

• Other Device: NR 

• Surgical: NR• Procedure:• Bladder catheterization: prior to 

RPE with a sterile catheterisation technique. In/out sterile bladder irrigation with normal saline post EJ to assess RG. 

• Protoscopy: test of rectal mucosa 

• Behavioural: NR• Laboratory techniques: NR 

• Outcomes: • Measures of Fertility Rate• Seminal Parameters: Sem

retrieval in 50% (6 of 12) emissions, volume range2.9cc; Sperm concentratrange=7.5-678 mln/cc; %range=0-60%; %Normal morphology range=0-55%4 of 9 produced semen wSpC adequate for AI. 

• EJ Rates: 10 of 12(83%) 

produced sperm on at leoccasion; Sperm obtaineof 38 rectal probe EJs. 

• Pregnancy rates: Spouse 

artificially inseminated bupregnancy achieved 

• Live Births: n=0 • Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-22

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Hellstrom, 

1989, US 

(Ref ID 

692) 

• Enrolled/ 

evaluated: n=13: n=11 SCI, n=1 diabetic & n=1 MS/ n=13 

• % males: 100%• Race/ethnicity: NR • Age: 32.1(26-45) y• Level of Injury: 

n=6 Cervical; n=5 Thoracic 

• ASIA Level: NR 

• Duration since 

injury: 7.7 (4-12) y 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: 

American Urological Association Scholarship & University of California

• Study Design: NCS • Duration: 14 mo 

• Eligibility Criteria: • Inclusion: all pts 

underwent physical exam, medical hx & lab work. No definite criteria listed. All pts included that attended EEJ clinic 

• Exclusion: NR • Quality

Assessment: 8/19 (+) reported 

• Pharmacologic: NR • Device: EEJ x 49 AI 2(All 

SCI pts) 

• Amplitude: NR• Frequency: 3 trial for each pt • Mode/Admin. Route: NR • Other Device: NR• Surgical: NR

Behavioural: NR

• Procedure (All pts): • Bladder catheterization 

with/without alkalinization: alkalization by admin. Of sodium bicarbonate orally for 36 hr. followed by rinse & instillation with tissue culture growth medium. 

• Epidydimal aspiration

(MESA/PESA) 

• Testicular biopsy: in all men 

testicular aspiration with a 23-gauge needle. DNA histograms collected within 4 d after aspiration. 

• Laboratory techniques: NR

• Outcomes: • Measures of Fertility Rates: • Seminal Parameters: (n=4) normal 

motilities (30% or greater); 3 pts haadequate sperms counts but low m(5% or less); 3 pts had mod abnormOf 5 pts with markedly abnormal histograms, 4 remained azoospermdespite repeated attempts at EE 

• Ovulation rates: Ovulation problems 

partner are reported. 

• Pregnancy rates: 1 of 2 AI following • Additional Outcomes:• Testicular biopsy results: 8 bilatera

unilateral biopsies performed. In (nnormal histograms found, (n=3) milabnormal, & in (n=5) markedly abnThere no relationship with semen qlevel or completeness or duration o

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-23

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/ Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/ Follo

w

Heruti, 

2001, 

Israel 

(Ref ID 

454) 

• Enrolled/evaluat

ed: n=84 (including 49couples)/ n=33follo

wed for 

pregnancy 

• % males: 100%

of n=84 ; 50% of 33 couples 

• Race/ethnicity:

NR 

• Age: 31.3 (19-

45) y

• Level of Injury: 

cervical 29 (34.5%), thoracic 50(59.5%), lumbar5 (5.9%), 

• ASIA Level: 

n=63 A; n=15 B; n=5 C; n=1 D 

• Duration since 

injury: 7.1 (4 mo34) y

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent:

11/19 (+) reported 

• Pharmacolo

gic: NR

• De

vice: 

• Amplitude: maximum voltage 20 V

• Frequency: maximum current 300 mA • Mode/Admin. Route: following an anoscopic

examination of rectal mucosa, lubricated probe inserted into rectum 

with pt in left 

lateral decubitus position. 

• Oth

er De

vice : NR

• Surgical : NR• Proc

edure (n=84):

• Bladder catheterization 

-plastic catheter, used saline solution & 

20cc Ham’s F-10 solution 

• Beha

vioural: NR 

• Laboratory techniques (n = 84): 

• Donor sperm insemination • Sperm preparation: Sperms prepared by

filtration 

with mini-percol in 3 gradients. 

Pentoxyl-phyllin & deoxy-adenosine to accelerate motility

• Intrauterine insemination: IUI is first line of 

tx 

with sperm analysis > 10.mln/cc 

• IVF: If 3 cycles of tx have failed, pts are 

referred for IVF. IVF is primary tx for Pts with <10 mln sperm/cc or mechanical problems of female 

• Intracytoplasmic sperm injection: ICSI is 

used for all pts that reach IVF, as this method is more successful 

with lo

w sperm 

rates 

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: • AG EJ sperm parameters (77 

volume (cc): mean 1.44+-1.3, sperm concentration (mln/cc)45.5, range 0-340; total SpC mean 57.9+-86.3, range 0-10(%): mean 7.9+-13.9, range (motile sperms (mln): mean 4.range (0-111); motility grade 2.1+-0.8, range (0-3.5); SpMosperm) mean 10.5+-12.8, ran

• RG EJ sperm parameters (77 

volume NA, sperm concentraSpC (mln/cc): mean 12.3+-33450; SpMot (%): mean 4.2+-184); total motile sperms (mln)2.7, range (0-36.3); motility gmean 1.9+-0.9, range (0-3.5)normal): mean 5.3+-8.0, rang

• S dif. bet

ween AG & RG in al

parameters. 

• EJ Rates: successful EJ rate: 

(124/350) of sti

mulations & 54

pts; total EJ rate 98.6% (350/found between pts 

with LMN 

• Pregnancy rates: overall rate/

after IUI: 33.3% (5/15); after I(14/20) 

• Live Births: n=26 • Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other)

Hirsch

1992, 

US 

(Ref ID 

974) 

• Enrolled/ 

evaluated: n=9/n=7 

• % male: 100%• Race/ethnicity:

NR 

• Age: NR • Level of Injury: 

(n=2) L1&T3(excluded fromanalysis) (n=7)C5-T12, n=5 complete, n=2 incomplete 

• ASIA Level: 

NR 

• Duration since 

injury: 6.8 (5-12) y

• Previous 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 7/19 

(+) reported 

• Pharmacolo

gic: 

• Drug name: nifedipine• Dose: 20 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: sublingually• De

vice: Electrical stimulator 

• Amplitude: NR• Frequency: with sine 

wave of 60 Hz, 

with 1 V increments for max of 3 

sec. & rest of 0.5 sec 

• Mode/Admin. Route: NR • Other De

vice: NR 

• Surgical: NR • Proc

edure: 

• Bladder catheterization • -with/

without alkalinization: Pre tx Medication: 2-d oral sodium

bicarbonate tore alkalinize urine 

• Epidydimal aspiration (MESA/PESA) 

• Beha

vioural: NR 

• Out• Mea

Fer

• Sem

volme74.mlnmocon28.No betanaparsevhistdefon bio

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

hormone; LH = luteinizing hormone; NIDRR = National Institute of Disability Research & Rehabilitation 

E-24
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other)

Hirsch

1992, 

US 

(cont’d) 

(Ref ID 

974)

• fertility: NR • Dropouts: n=2 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: 

Regional Spinal CordInjury Center of the Dela

ware

Valley; NIDRR 

• See above • Laboratory techniques: 

• Sperm preparation: A-G ejaculates analyzed after liquefaction for 30 m 

at 370C. Seminal plasma separated by at centrifugation at 2,000 RPM for 10 m. Samples frozen at –200C until time of testing. ELISA performed on seminal plasma. Microtiter plates prepared by coating with 100ug/ml for 1 hr at 250C. Plates 

washed x 3 

with PBS & coated 

overnight at 40C 

with sperm suspended in PBS at concentration of 2.5 

x 10 sperm/

well. To decrease non-specific binding plates 

washed x 3 

with PBS coated 

with 200uL/

well of blocking agent & left on plate x 15 

m. After blocking step, each well filled with 100 uL of serial dilutions of test seminal plasma as 

well as (+) & (-) ctrls. Plate incubated for 1 hr at 

370C. After incubation, 10-step

wash 

with PBS 

T

ween 1% N.G. 

Sperformed & plate coated 

with blocking agent. After this each 

well 

(apart from 1st ro

w used for blanking) filled 

with 100 uL of alkaline 

phosphates conjugated, goat antihuman IgG, IgA & IgM, heavy &light chain specific secondarily antibody sol. Plate read for absorbance at wavelength of 405 nm on Titertek ELISA scanning spectrophotometer. 

• Background absorbance calculated by averaging secondary antibody

ro

w absorbance values. This value subtracted from observed 

absorbance values to obtain actual absorbance values. Values > than 0.100 indicative of (+) reaction 

• plas

demantantres

• Add

Ou

• No 

betdegsem(spconmospesemtes(n=spe

• Fol

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

hormone; LH = luteinizing hormone; NIDRR = National Institute of Disability Research & Rehabilitation 

E-25
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-26

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/ Follo

Hultling, 

1994, 

S

weden

(Ref ID 

598) 

• Enrolled/ evaluated: 12 

couples/ n=12 couples 

• % males: 50% of 12 

couples 

• Race/ethnicity: NR • Age: 34 (27-38) y• Level of Injury: cervical 

C4-C6: (n=4); thoracic T4-T12: (n=7); lumbar L3: 1 

• ASIA Level: n=8 A; n=

2 C; n=2 D 

• Duration since injury: 

(4-33) y

• Previous fertility: all 

spouses of SCI pts had regular menstrual cycles & healthy on routine gyn. Exam; 7 nulligravidae, 5 I-II gravidae; 3 hadchildren from previous marriages 

• Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: MRC,

S

weden; Spinalis 

Foundation; Karolinska Institute 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: infertile male pts 

with SCI living in stable relationships with their female partners who express a strong 

wish for fatherhood 

& attending Solberga Spinal Cord Injury Project during January 1992 – November 1993 

• Exclusion: NR• Quality Assessment: 6/19 

(+) reported 

• Pharmacolo

gic: physostigmine in 

combination with vibration/ nifedipine (tx of autonomic dysreflexia) 

• De

vice: Vibrator & (n = 12) 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: VS used first 

in combination 

with physostig

mine 

• Oth

er De

vice: Electrical 

stimulator: 

• Mode/Admin. Route: transrectal 

ES usually under general anesthesia. 

• Surgical: NR• Proc

edure: NR

• Beha

vioural: NR 

• Laboratory techniques:• IVF: GnRH-agonist 

(nafarelin/buserelin) intranasallystarting d 1 or 21; HMG or Fertinorm HPR daily 10-12 ds (150-300 IU/d). Both partners received prophylactic antibiotic tx with metronodazol & doxycycline. 

• Oocyte retrieval: 37 hrs after 

vaginal ultrasound-guided follicular aspiration then percultured for 3-4 hrs preinsemination 

• Outco

mes: 

• Measures of Fertility • Seminal Parameters

concentration (mln/m91; range 3.5-202; % sperm: median 11; rtotal motile SpC (mlnmedian 73; range 11concentration in prepsperm (mln/ml): medrange 2.5-2.5; % of msperm in prepared smedian 27.5; range total count of motile prepared sperm (mlnmedian 2; range 0.1

• Ovulation rates: 23 o

cycles in 12 women 

• Pregnancy rates: 7 

pregnancies in 6 coupregnancies in 1 cou

• Miscarriage/ectopic: • Live Births: n=3 • Singletons: n=1 • Multiples: n=1 • Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

retrograde; MRC = medical research council
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g. Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Fol

Hultling, 

1997, 

S

weden

(Ref ID 

538) 

• Enrolled/evaluated: 

25couples/ n=25 couples 

• % male: 50% of 25 

couples 

• Race/ethnicity: NR • Age: male: age 34 (25-

51) y; women: age 31(21-38) y

• Level of Injury: range C2-

L3 

• ASIA Level: n=18 A; 

n=7: NR 

• Duration since injury: NR • Previous fertility: n=18 

women nulligravidae; n=7 gravidae I-II; n=4 children born from previous relationship; n=2 

women had a hx of 

endometriosis & n=2 PCOS; n of previous pregnancies: 7 gravidaeI-II

• Study Design: NCS • Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: stable 

relationship, motile spermatozoa in a diagnostic sample 

• Exclusion: NR • Quality Assessment:

9/19 (+) reported

• Pharmacologic (n

=25):

• Drug name: nifedipine• Dose: 10-25 mg• Duration: NR • Schedule: NR • Mode/Admin. Route: sublingually pre-ES or

VS

• De

vice: Vibrator 

• Amplitude: 2.5 mm • Frequency: 100 Hz • Mode/Admin. Route: duration of 204 m & 

repeated up to 8 times 

• Other Device: Electrical stimulator: • Type: 

• Manufacturer • Voltage: 7-35 V • Duration: 2-4 s• Mode/Admin. All pts 

with residual sensation 

in perineum &/or rectum underwent EEJ 

with

general anesthesia: atropine prior to induction; alfentanyl 1-2 mg; 2-3 mg/kg propofol administered & supplemented with 5-15 mg/kg/h

• Surgical: NR 

• Outco

mes: 

• Measures of Fertil• Seminal Paramete

SpC: median 185range 0.01-978; mmedian 32 mln, ra97.1 

• Ovulation rates: to

ovulatory cycles opartner: 52 

• Pregnancy rates: 

pregnancies (30.7

• Miscarriage/ectop

or 2nd trimester & 

intrauterine death gestation 

• Fertilization rate (t

fertilized eggs/totaeggs): 52.3

% (300

embryos (% of fer84.7% 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minute

= control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = vmillions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of particevaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; 

sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegra

polycystic ovary syndrome; E

EJ = electro ejaculation; MRC = medical research council

E-27
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g. Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcom

Hultling, 

1997, 

Sweden

(cont’d) 

(Ref ID 

538)

• Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: MRC, Sweden; 

Spinalis Foundation; Karolinska Institute Funds; Norrbacka Eugenia Foundation

• See above • Behavioural: NR

• Laboratory techniques (25 couples): • Ovarian stimulation: Down-regulation with

gonadotrophin-releasing hormone agonist, nafarelin, or buserelin, stating on cycle d 1 or 21. HMG, or purified FSH 

• IVF: antibiotic tx with metronidazole, 0.5 g 3x a d for 5 

d & doxycycline, 0.1 g a d for 7 d, given prophylactic to all couples 

• Embryo transfer: n=47 

• (254/300• Live Birth• Singleton• Multiples• Follow-u

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minute

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = vo

treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrol

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm c

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retrog

syndrome; EEJ = electro ejaculation; MRC = medical research council E-28
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w

Kolettis, 

2002, US 

(Ref ID 

424) 

• Enrolled/ evaluated: 

n=27(including 9 SCI with their partners)/ n=9 evaluated for conception

• % males: 50% of 

couples 

• Race/ethnicity: NR • Age: NR • Level of Injury: n=10 

cervical, n=16thoracic, n=1 lumbar 

• ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Drop-outs: n=0 • Lost to follo

w-up: n=0 

• Number of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: 1993-2001 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 8/19(+)

reported 

• Pharmacolo

gic: NR

• De

vice: Electrical 

stimulator(n=27) 

• Amplitude: 12-18 V/ current of

400-600 mA 

• Frequency: N

R

• Mode/Admin. Route: 30 sec 

bursts of stimulation performed 

• Oth

er De

vice: NR

• Surgical: NR• Proc

edure: NR

• Beha

vioural: NR

• Laboratory techniques:• Donor sperm insemination: NR • Sperm preparation: NR • Intrauterine insemination: 25

cycles performed 

• IVF: 3 cycles of IVF• Intracytoplasmic sperm 

injection: 2 cycles of IVF-ICSI performed 

• Embryo cryopreservation: NR• Sperm cryopreservation: NR 

• Outco

mes: 

• Seminal Parameters

prep median total mo& motility /procedure 7% respectively; 28 cycles(32%) yielded sperm 

• EJ Rates: 112 EJ att

made, 43/112(38%) A24(21%) RG; 45(40%AG+RG 

• Cycle Function: 25 cy

IUI, 3 cycles of IVF & of IVF-ICSI 

• Pregnancy rates: 3/9 • Live Births: 2/9(both • Multiples: 2 sets of t

w

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-29
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-30

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Leduc, 

1992, 

Canada

(Ref ID 

2252) 

• Enrolled/evaluated: 

n=37/n=3 evaluated for conception

• % males: 100% of

37; 50% of couples 

• Race/ethnicity: NR • Age: 29.5 (19-61) y• Level of Injury: 

n=15 Cervical; n=22 Thoracic (29 complete; 8 incomplete) 

• ASIA Level: NR 

• Duration since 

injury: 3 mo-23 ymean 7.4 y 

• Previous fertility: 

NR 

• Dropouts: n=13 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: 6/19 (+) reported 

• Pharmacologic: 

• Drug name Butylbromure hyoscine, 

Interventional drug specified for this review: Physostigmine 

• Dose/admin: Butylbromure hyoscine 

injection: 40 mg subcutaneous 30 m prior to administration of physostignime: 2 mg subcutaneous & repeated (1-2 mg) if not EJ reached (n=7 up to 4mg); Nifedipine: 10 mg sublingual 

• Device: NR 

• Other Device: NR 

• Procedure: NR 

• Behavioural: NR 

• Laboratory techniques: 

• Donor sperm insemination • Sperm preparation: Semen collected

for analysis post physostigmine induced EJ in a sterile container 

• Intrauterine insemination: 0.5 ml of 

unwashed fresh sperm inseminated into cervix. This procedure also done at home as well as in hospital

• IVF in 6 couples• Intracytoplasmic sperm injection

• Outcomes: 

• Measures of Fertility Rates: • Seminal Parameters (n=46): 

Mean SpC: 134 mln/mL, Range: 2-285. Mean motility:28%, range: 1-67% 

• Insemination rates: 

Insemination performed once in one of partners, 3 times in another & 15 times in other 

• Pregnancy rates: (n=3) in 3 

couples 

• Live Births: (n=3) • Follow-up: NR 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minute

group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = hertz; m

history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified

three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = spmorphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retrograde 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-31

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g, Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Lim, 

1994, 

Australia 

(Ref ID 

333) 

• Enrolled/evaluated: 

n=12/n=12 

• % male: 100%• Race/ethnicity: NR • Age: 13 (21-36) y• Level of Injury: n=6 

C4-C6; n=7 T10-T12; n=1 L2 

• ASIA Level: NR 

• Duration since 

injury: 8 (1-24) y 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: 26 mo 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: 10/19 (+) reported 

• Pharmacologic (n=x): NR 

• Device: Electrical stimulator 

(n=12)

• Amplitude: 500 mA • Frequency: sine wave 

currency 20 Hz at a maximumof 16 V 

• Mode/Admin. Route: • Other Device (n=12): • Type: vibrator @ 60 Hz • Manufacturer: Jeou Jen 

Electric Co. 

• Surgical: NR • Procedure (n=12):

• Bladder catheterization: Foley 

catheter/no alkalization 

• SpMot /manual assessment 

of % of motile sperm & motility analysis

• Behavioural: NR • Laboratory techniques: NR 

• Outcomes: 

• Measures of Fertility Rates: • Seminal Parameters: • Sperm volume: range 0.1-8.5 ml; sp

concentration: 0-500 mln/ml; SpMo80%; normal forms: 6-46% 

• repeated stimulation had a + effect 

semen quality

• Volumes & concentration of s

greater in EEJ vs. VE, but NS notSpMot 

• Additional outcomes: Silicone 

catheters had minimal effects on S& viability. All lubricant gel found to adversely affect sperm quality

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-32

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcome

Lucas, 

1991, UK 

(Ref ID 

667) 

• Enrolled/evaluated: 

n=14: n=12 SCI; n=2 diabetic/n=14 

• % males: 100%• Race/ethnicity: NR • Age: 34.6 (25-46) y• Level of Injury: 92%, 

n=3 Cervical; n=9 thoracic (n=10 complete, n=2 incomplete) 

• ASIA Level: NR 

• Duration since 

injury: 9.9 (2-22) y

• Previous fertility: 

secondaryanorgasmy, due to diabetes (n=2)

• Dropouts: (n=2) • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: 26 sessions 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment:

6/19 (+) reported 

• Pharmacologic (n=12, SCI T6): • Drug name: glyceryltrinitrate or nifedipine• Dose: 20-40 mg• Duration: NR • Schedule: 20 m pre-procedure • Mode/Admin. Route: sublingually• Device: Electrical stimulator (n=14) 

• Amplitude: up to 35 V, current up to 900 mA • Frequency: 50 Hz • Mode/Admin. Route: rectal probe (PVC, 11/8 or 

11⁄4 inches in diameter) with pressure to contact with ant. Rectal wall 

• Other Device: NR • Surgical: NR • Procedure (n=14):

• Bladder catheterization 

- aseptically & washed with Ham’s F 10 solution. Recatheterization after an AG EJ or 100% erection 

• Protoscopy: after procedure • Testicular biopsy: NR • Behavioural: NR 

• Laboratory techniques (n=14):• Donor sperm insemination • Sperm preparation: (n=8) centrifusion / & 

resuspension in a solution of 10% wife’s serum supply. By Hams F 10 solution (swim up) to prepare for AIH 

• Embryo cryopreservation: • Sperm cryopreservation: (n=9) 

-ejaculated: Std technique with egg yolk & glycerol 

• Outcome• Measures 

Rates: 

• Seminal 

Vol. rangml; % of motility: 0concentr

• Pregnanc

(AIH, RG 

• Live Birth• Singleton• Multiples• Genetic a

none 

• Follow-u

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

insemination from husband
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-33

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Mallidis, 

1994, 

Australia 

(Ref ID 

966) 

• Enrolled/evaluate: 

n=7/n=7 

• % male: 100%• Race/ethnicity: NR • Age: NR (18-39) 

y 

• Level of Injury: 

n=6 C4 –6 , n=2 T4 –9 

• ASIA Level: NR 

• Duration since 

injury: 2-15 d 

• Previous fertility: 

NR 

• Dropouts: n=2 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: EEJ

performed every 2 d 

• Eligibility Criteria: • Inclusion: 2-15 d postinjury, Traumatic SCI, 

No known hx of testicular dysfunction 

• Exclusion: NR • Quality Assessment:

8/19 (+) reported 

• Pharmacologic: NR • Device: Electrical stimulator 

(n=7) 

• Amplitude NR • Frequency: every 2 d; 2-13 

EJ/pt 

• Mode/Admin. Route: insertion of 

rectal probe (CGS electroejaculator) 

• Other Device: NR • Surgical: NR • Procedure:• Bladder catheterization – 

suprapubic indwelling catheter, nasogastric tube & intravenous 

line for fluid & medication inserted & calf stimulator applied 

• Behavioural: NR • Laboratory techniques (n=7): • Donor sperm insemination • Sperm preparation: semen 

collected in warm, sterile plastic jar 

• Sperm cryopreservation: • -ejaculated: TEST egg-yolk 

buffer & vapour-frozen. Postthaw motility after cryopreservation 

• Protoscopy: pre/post procedure 

• Outcomes: • Measures of Fertility Rates: • Seminal Parameters: • Of 6 pts that started EEJ 2-3 d afte

5 had few sperms (<2-x10 mill/ml) no sperm in first sample. 

• 3 pts who had EEJ 48 h later had 

sperm in semen.

• Samples collected from 4 men bet

after injury had normal sperm & m

• Subsequent samples tended to ha

decreasing sperm viability & motil

• 5 pts produced samples suitable f

cryopreservation. Post-thaw spermrecovery (range 36%-74%, mean similar to that of normal-donor cryopreseved semen. 2 pts did noproduce samples suitable for cryopreservation 

• EJ Rates: 46 EJs done (range 2-1• Additional Outcomes: processes 

responsible for loss of semen quaappear to become established quafter SCI. Post-thaw motility showcryopreserved samples as good astored from healthy men. collectiosemen early after SCI can insure 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R

ejaculation 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-34

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Mallidis, 

2000, 

Australia 

US 

(Ref ID 

472) 

• Enrolled/evaluate

d: n=9/n=9 

• % male: 100%• Race/ethnicity:

NR 

• Age: 28 (22-36) y• Level of Injury: 

n=2 C5-C6; n=6 T4-T11; n=1 L2

• ASIA Level: NR 

• Duration since 

injury: 54 (8-103) mo 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: 4 

consecutive d 

• Eligibility Criteria: • Inclusion: males 16-40 

y; ≥6 mo duration of SCI; no known or suspected testicular dysfunction (past undescended tests or infertility) 

• Exclusion: NR • Quality Assessment:

8/19 (+) reported 

• Pharmacologic: NR • Device: Electrical stimulation 

(n=9) 

• Amplitude: max 16 V • Frequency: sine-wave current

20 Hz 

• Mode/Admin. Route: daily EEJ 

for 4 consecutive d n=6; EEJ for 3 consecutive d n=2 & EEJ for 1 d n=1 

• Other Device: NR • Surgical: NR • Penile Implants 

• Procedure:• Bladder catheterization: NR • Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: fine needle 

tissue aspiration biopsy in (n=5) (>1mont pre EEJ n=2/ on last d of EEJ n=3) 

• Behavioural: NR • Laboratory techniques (n=9): • Electron Microscopy: in 15 

semen samples

• Outcomes: • Measures of Fertility Rates: • Seminal Parameters: mean SpMo

on d 2 vs. d 1 23 (6.9) %; mean spviability increase on d 2 vs. d 1 24

• Overall, major gains in SpMot & vi

achieved by d 2, although in 3 ptsimprovement in motility & viability into d 3 

• Testicular Biopsy: normal n=3; one

normal n=1, other had moderately hypospermatogenesis; slight hypospermatogenesis n=1. 

• Additional Outcomes: Electron Mic

(n=9) all 9 d 1 samples showed mdegeneration of spermatozoa; samrepeated EJ showed improved ultwith fewer degenerative features

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcome

Nehra,

1996, US 

(Ref ID 

91) 

• Enrolled/ 

evaluated: n=78; 33 couples for conception/ 27 couples evaluated for conception

• % males: 100%• Race/ethnicity:

NR 

• Age: 26.9 (23-40) 

y 

• Level of Injury: 

cervical 37; thoracic above T10 26; thoracicbelow T10 15 

• ASIA Level: NR • Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: 6/33

poor semen quality not candidates of assisted fertilization 

• Lost in follo

w-up: 

NR 

• N of sites: NR • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR (pts 

with poor semen quality not candidates of assisted fertilization) 

• Quality

Assessm

ent: 7/19 

(+) reported 

• Pharmacolo

gic: 

• Drug name: clo

miphene citrate daily (ovulatory enhancement) 

• Dose: 50 mg • Duration: on d 5-9 of cycle • Schedule: NR • De

vice: Electrical stimulator 

• Amplitude: 22 V, max of 420 mA • Frequency: 60 Hz • Mode/Admin. Route • Oth

er De

vice: 

• Type: Vibrator oscillation rate of 1800 rmp • Manufacturer: NR • Admin: 3-4 m stimulation 3 x if necessary• Surgical: NR • Proc

edure: 

• Bladder catheterization: NR • Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: in 3 pts revealed maturation arrest pattern. • Beha

vioural: NR 

• Laboratory techniques:• Donor sperm insemination • Sperm preparation: NR • Conception techniques: cervical self-insemination (n=5), IVF & 

gamete intrafallopian transfer (n=12) 

• IVF: for intrauterine insemination 

with human menopausal 

gonadotropins. IVF & gamete intrafallopian transfer combined with rectal probe EEJ (before laparoscopic oocyte harvestingor just after trasvaginal ultrasound guided oocyte retrieval. Fertilization assessed at 24 h & uterine transfer accomplished for max of 4 selected embryos 48-72 h post oocyte retrieval 

• Embryo cryopreservation: in all excess embryos • Sperm cryopreservation: ejaculated; biopsy

• Outco

m

• Measure

Rates: 

• Seminal 

after EE: concentrmln/cc; S

• EJ Rates

rate after stimulatio(34/78); injury: ce(20/37); tabove T1(14/26); tbelow T1

• Pregnan

overall prate: 63% 

• Miscarria

(n=1) 

• Live Birth

births in triplets, 2 singletoncouple is triplets & singleton 

• Singleton• Multiples

triplets 

• Foll

o

w-u

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = min

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = voltstreatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; en

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sper

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-35
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-36

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-u

Matthews, 

1996, 

US 

(Ref ID 

563) 

• Enrolled/evaluated: 

n=40: n=18 SCI; n= 9 retroperitoneal LND; n=9 idiopathic or psychogenic; n=4 diabetes mellitus/ n=33 couples evaluated for conception

• % male: 100%of 40 

SCI; 50% of 33couples 

• Race/ethnicity: NR • Age: NR • Level of Injury: n=2 

cervical; n=15thoracic; n=1 lumbar 

• ASIA Level: NR 

• Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR 

• Eligibility Criteria: • Inclusion: men with

ejaculatory function 

• Exclusion: NR • Quality Assessment:

9/19 (+) reported 

•Pharmacologic: NR 

•Device: Electrical stimulator 

•Amplitude: NR

•Frequency: NR

•Mode/Admin. Route: rectal 

probe insertion

•Other Device: NR 

•Surgical : NR •Procedure: NR

•Behavioural: NR 

•Laboratory techniques:•Sperm preparation; NR 

•Intrauterine insemination: 

126 cycles in n=33 

•IVF: n=7, total of 14 cycles 

•Intracytoplasmic sperm 

injection: NR 

•Outcomes: 

•Measures of Fertility Rates: 

•Seminal Parameters: motile sper

rate: 16/18 (89%); mean total mrecovered per rectal probe EEJ 360(73); AG 92(19); RG 351(54ejaculate contained Sly more m(p<0.05); % motility: AG 25(3)%

•EJ Rates: 94% (17/18) 

•Cycle Function: mean total IUI cy

mean intrauterine insemination (pregnancy): 3.0(0.8); % IUI per fecundity=14.3 

•Pregnancy rates: 45% (5/11) 

•Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; 

treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enn analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC 

motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade

ejaculation 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-37

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-u

Odum, 

1995, 

Denmark 

(Ref ID 

1166) 

• Enrolled/evaluated: 

n=12/ n=12 

• % male: 100%• Race/ethnicity: NR • Age: NR (21-45) y• Level of Injury: C2-

T12; n=9 complete, n=3 incomplete

• ASIA Level: NR • Duration since 

injury: 7 (1-29) y 

• Previous fertility: NR • Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: Gerda & 

Aage Haensch'sFond & DanishBiotechnology Center for Neuropeptide Research 

• Study Design: NCS • Duration: 12 mo 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

7/19 (+) reported 

• Pharmacologic: NR• De

vice: Vibrator (n=12) 

• Amplitude: peak to peak 2.5 mm • Frequency: 100 Hz • Mode/Admin. Route: once 

wkly for a 

period bet

ween 6-12 mo 

• Oth

er De

vice: electrical stimulator 

• Dose/Frequency: NR • Surgical: NR • Beha

vioural: NR 

• Laboratory techniques:

• Donor sperm insemination: NR • Sperm preparation: NR • Plasma extraction (frozen & tha

wed

& proteinase inhibitors added to final concentrations: benxamidine 50mM, ED

T

A 0.3 mM, leupeptin 1μM 

& PMSF 100μ & centrifuged at 2000 G for 20 m 

• Outcomes: • Measures of Fertility Rates• Seminal Parameters: (Sem

plasma Somatostatin Concentration: SSC): Margbet

ween SpMot rates in S

T6 (0%motile range: 0-30) or above T6 (median=16%range: 10-37) (p=0.09). A to

wards lower motility in sa

with SSC vs. samples 

with

(correlation coefficient =-0normal SSC in lesions beloSSC did not correlate 

with 

volume, SpC, or morpholoof stimulation (VS vs. ES) effect semen quality or SS

• Foll

o

w-up: every 3 mo for 

resulted in no S dfs in SSC baseline 

with repeated VE 

performed at home 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-38

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Ohl, 

1989, 

US 

(Ref ID 

385) 

• Enrolled/evaluated: 

n=48 / n=48 

• % male: 100%• Race/ethnicity: NR • Age: 31 (20-53) y• Level of Injury: n=15 

cervical (31%); n=29 thoracic (61%); n=4 lumbar (8%); (56% complete; 44% incomplete) 

• ASIA Level: NR • Duration since 

injury: 8 y; (4 mo-34) 

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: Supported 

in part by Eastern Paralyzed Veterans Association 

• Study Design:

NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: 4/19 (+) reported

• Pharmacologic: NR • Device: Electrical Stimulator 

• Amplitude: 500-600 mA • Frequency: NR• Mode/Admin. Route: NR • Other Device: NR 

• Surgical: NR • Procedure:• Bladder catheterization in (n=48) • -15-10 ccHamm’s F 10 solution with 

20 mm Hepes buffer in case of pH 6.5. 

• Methods: Intermittent catheterization 

in 28, Suprapubic tube in 2; Indwelling urethral catheter 2;Sphicterotomy in 8; Spontaneous voiding in8 

• Epidydimal aspiration (MESA/PESA) • Testicular biopsy• Behavioural: NR 

• Laboratory techniques: NR

• Outcomes: • Measures of Fertility Rates: • Seminal Parameters: average 

=765 mln/ml & average total =226 mln/ml; predominant foprogression 3+; average SpMaverage N morphological formsuccessful EJ rate: 71% (34/

• EJ Rates: Successful EJ rate 

bladder management: intermcatheterization: 85%; indwellcatheter 50%; sphincterotomspontaneous voiding 38%. Srate by level of SCI: thoracic 60%; lumbar 50%. SuccessfuASIA: A 77%; B-D 61% 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-

Ohl, 

1992, 

US 

(Ref ID 

649) 

• Enrolled/evaluated: n=38 

Neurogenic bladder grps: n=28 SCI & n=1 MS; Normal bladder grp: n=7; Cancer; n=1 diabetic neuropathy; n=1 psychogenic/ n=33 evaluated for conception

• % male: 100% of 38 SCI 

pts; 50% of couples 

• Race/ethnicity: NR • Age: 31.6 (23-47) y• Level of Injury: (n=9) 

cervical, (n=18) thoracic, (n=1) lumbar), 

• ASIA Level: NR • Duration since injury: NR • Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: Eastern 

Paralyzed Veterans Association 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 6/19 

(+) reported 

• Pharmacolo

gic: NR

• De

vice: Electrical 

Stimulator (n=38) 

• Amplitude: up to 500 mA • Frequency: N

R

• Mode/Admin. Route: mean

stimulation time, 7-8 m. (bulbous urethra massaged during stimulation) (n=16) under

went second EEJ trial 

with cultures 

• Other De

vice: NR 

• Surgical: NR • Proc

edure (n=29): 

• Bladder catheterization • Alkalization: sodium 

bicarbonate orally at 12 & 1 hr pre procedure to ctrl urinary acidity (EEJ). 

Type

of bladder management: ISC in (n=12), sphincterotomy/condom in(n=5); reflex voiding in (n=8); ind

welling urethral

catheter in (n=1); suprapubic catheter in (n=2); lleal loopin (n=1) 

• Beha

vioural: NR 

• Laboratory techniques: 

NR 

• Outcomes: • Measures of Fertility Rates: • Seminal Parameters: Effect of 

management on SpC in NGB gnon-ISC grp average total SpC motility & total motile SpC slighISC grp. In RG no 

∆ in SpMot, 

SpC & average total SpC subsin ISC grp. In both AG&RG comtotal motile sperm slightly high

• Infection rates: In first EEJ (n=

urine positive; In second EEJ 7 positive & 6 of 12 semen positcultures in neurogenic bladder 

• Pregnancy rates: (n=8); 5 in N

thoracic, 2 cervical, 1LMN, 4UNGB 

• Foll

o

w-up: (artificial insemina

• Length: 15-18 mo • Results: (n=24) in NGB & (n=9

bladder 

• Pregnancy rate: 44% for ISC & 

types of bladder management.

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-39
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Ohl,

1997, US 

(Ref ID 

305) 

• Enrolled/ evaluated: 

n=11/ n=11 

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Drop-outs: n=0 • Lost to follow-up: NR • Number of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: 8/19 (+) 

reported 

• Pharmacologic: NR • Device: FertiCareclinic Vibrator 

(n = 5) 

• Amplitude: 2.5 mm • Frequency: 100 Hz • Mode/Admin. Route: 3 m of VS 

or until EJ occurred 

• Other Device (n = 6): 

Electrostimulator 

• Type: Seager Model 11 (double 

dagger) with 1.25 inch probe 

• Manufacturer: NR • Surgical: NR • Procedure:• Bladder catheterization • -with/without alkalinization: 

without alkalization pre & post tx. 

• Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: NR 

• Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: • Seminal Parameters

AG SpC in VS vs. ESgreater motility (26.0 10.7%), viability (25.2 9.7%) & motile SpC (mln vs. 97 mln) in VSimmunobead test, cemucus penetration openetration assay; pehamster egg penetra(53.7% for VS vs. 22p=0.06); greater pain for ES vs. VS (5.2 vsall pts preferred VS. 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-40
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-41

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/ Quality

Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-

Ohl,

2001, US 

(Ref ID 

3059) 

• Enrolled/ 

evaluated: n=87 (SCI) 

• males: 50% • Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since NR • Previous fertility: 

NR 

• Drop-outs: n=NR • Lost to follow-up: 

NR 

• Number of sites:1 • Funding: NR 

• Study Design: NCS • Duration: NR • Eligibility Criteria:• Inclusion: NR • Exclusion: NR • Quality Assessment: 

6/19 (+) reported 

• Pharmacologic: sublingual

nifedipine given to pts above T6prone to dysrelexia 

• Device: electroejaculation with 

Seager machine 

• Amplitude: NR • Frequency: NR• Mode/Admin. Route: rectal • Schedule: NR• Other Device:• Type: catheter to obtain 

retrograde specimen 

• Manufacturer: NR • Surgical: female partners 

underwent hysterosalpingography & laparoscopies to exclude structural female infertility

• Behavioural: NA • Laboratory techniques: artificial 

insemination enhanced with gonadotropin therapy, IVF was performed on those who could not conceive & who could afford associated costs 

• Outcomes: 28/87 SC

couples achieved at one pregnancy 

• Seminal Parameters: • EJ Rates: NR • Follow-up: followed t

pregnancy or failure

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (continued) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/ 

other) Outcomes/Follo

w

Perkash, 

1985, 

US 

(Ref ID 

989)

• Enrolled/evaluated: 

n=30/ n=30 

• % male: 100%• Race/ethnicity: NR • Age: 32 (20-47) y• Level of Injury: n=27 

T2-T12; n=3 L1-L3 

• ASIA Level: NR • Duration since injury: 

6.3 (0.3-21.7) y 

• Previous fertility: NR • Dropouts: n=8 • Lost in follow-up: NR • N of sites: 1 • Funding: NIMH; base 

grant from NIH to Yerkes Regional Primate Research Centre of Emory University; & grant from Spinal Cord Research Foundation of the paralyzedveterans of America 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

7/19 (+) reported 

• Pharmacolo

gic: NR 

• De

vice: Electrical stimulator 

(n=30) 

• Amplitude: (Current: step

wise 

from lo

w to high currents every 

2 sec enough to elicit penile tumescence &/or seminal emission0 

• Frequency: 20 Hz • Mode/Admin. Route: • Other Device: NR • Surgical: NR • Proc

edure:

• Bladder catheterization: 

irrigation 

with neomycin sulfatepolymyxin B sulfate 

solution/drainage 

• Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: (n=13) 

volunteered with no anesthesiavia std surgical procedure 

• Serum hormone analysis: 

(n=30) levels of estradiol17ß/Follicle-stimulation & luteinizing hormones /Serum prolactin via radioimmunoassay

• Beha

vioural: NR 

• Laboratory techniques: NR

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: SpC in 

mln. Total SpC in 22 pts>20 mean 55%, range 40-75%; Sprogressive motility <20% in specimens, no motile in 10 sless than 10% motile in 13, motile in 4 & more than 30%

• Biopsy: Biopsy specimens (n

suggested normal testicular with tube atrophy & spermatactivity only mildly reduced.

• Serum testosterone & lutein

hormone values Sly higher (SCI than normal volunteers. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

Institutes of Mental Health; NIH = Nation Institute of Health

E-42
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d). 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-u

Pry

or, 

1995, 

US 

(Ref ID 

591)

• Enrolled/evaluated: 

n=6/ n=6 

• % male: 100%• Race/ethnicity: NR • Age: NR (30-36) y• Level of Injury: C4-

C7 

• ASIA Level: NR • Duration since 

injury: 6-18 y 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: hx & physical 

exam, preliminary lab evaluation, informed consent (1 trial of vibratorystimulation to determineseminal parameters, rule out infection & to determine need for sympathomietics) 

• Exclusion: NR • Quality Assessment: 

5/19 (+) reported 

• Pharmacolo

gic: 

• Drug name: in cases 1, 2, & 4 

ephedrine (& sodium bicarbonate) 

• Dose: 50 mg • Duration: 10 d • Schedule: NR • Mode/Admin. Route: NR • De

vice: Vibrator (Acuvibe 6002) 

• Amplitude: NR• Frequency: Vibrator speed 

range from 2,800rpm to 4, 29,000rpm 

• Mode/Admin. Route: Time from 

vibrator application to EJ variedfrom 5-45 m/ stimulation/ rest in5 m increments for subsequent vibrations 

• Oth

er De

vice: NR 

• Surgical: NR • Beha

vioural: NR 

• Laboratory techniques (n=6): • Sperm preparation • -s

wim-up technique 

• Intrauterine insemination: in all 

cases; case 2 partner: imipramine 25 mg t.i.d for 10 d, case 6 & 3 partners put on clomiphene citrate to regulate ovulation cycles

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: Case 1 

vol. AG -1.1ml-3.0 ml, RG10-30.5 mln/ml to 106 mln/ml. M30%, Morphology 16-52% no2 AG =. 4-3.2 ml, RG =32.5-1.3 mln/ml to 2,800 mln/ml; Mo35%; Morphology - 6-10%no3 AG 0.7-4.5 ml RG 1.8-78 mmln/ml; Motility 0-45%; Morph16% normal; Case 4 AG 0 mml. SpC 0-600 mln/ml; Morphnormal; Case 5 AG vol. 2-20m340ml; Count 1.28 mln/ml-30Motility 25-35%; Morphology Case 6 AG vol. 1 unable to e3.1 RG vol.28-55; Count .93 Motility <10%-70%. Morpholoavailable 

• EJ Rates: Case 2 -4 EJ; Cas

Case 4- 3 EJ; Case 5-2 EJ & EJ reported 

• Ovulation rates: 6 case 1 con

5th cycle, 5/6 normal ovulato1/6 irregular ovulatory functio

• Infection rates: (n=1) UTI • Pregnancy rates: (n=5) • Miscarriage/ectopic: (n=1) at 

gestation 

• Live Births: (n=5) • Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = 

count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

retrograde; UTI = urinary tract infection 

E-43
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other)

O

Pry

or, 

2001, 

US 

(Ref ID 

439)

• Enrolled/evaluat

ed: 11 couples/ n=11 couples 

• % male: 50% of

couples 

• Race/ethnicity:

NR 

• Age: NR • Level of Injury: 

NR 

• ASIA Level: NR • Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility

Criteria: 

• Inclusion: 

quadriplegic men with SCI presented at Abbott InjuryFertility Program over 3 y, who desired paternity

• Exclusion: NR • Quality

Assessm

ent:

10/19 (+) reported 

• Pharmacolo

gic: 

• Drug name/Dose/ Admin: nifedipine to prevent headache & autonomic 

dysreflexia; 50 mg clomiphene citrate on d 5 through 9 of menstrual cycle to enhance female partner's ovulatory cycle; hCG, 10 000 IU, administered 

when dominant follicle 15-20 m

m & estradiol range of 

each follicle 200-300 pg/ml)/ Oral sodium bicarbonate 

• De

vice: Electrical Stimulation

• Amplitude: 0-10 V for 1st & 2nd stimulation, 15-29 V, 20-30 V, & 15-20 

V for subsequent stimulations

• Frequency: N

R

• Mode/Admin. Route: 30 sec stimulation followed by 45 sec rest. 

Repeated stimulations administered for second time. Following stimulations admin 

with higher voltages 

• Oth

er De

vice: Vibrator 

• Type: Acuvibe 6002 • Manufacturer; Brookston • Surgical: NR • Proc

edure: 

• Bladder catheterization: irrigation 

with Ham’s F-10 solution

• -alkalinization by oral sodium bicarbonate solution for 36-48 h • Epidydimal aspiration (MESA/PESA): NR 

• O• M

F

• S

PmafspteMprmavinloin (3in 3 m5.

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R

E-44
Appendix E. Evidence Tables (continued)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other)

O

Pryor, 

2001, 

US 

(cont’d) 

(Ref ID 

439)

•See above • See above • Testicular biopsy: NR 

• Behavioural: NR 

• Laboratory techniques (n=11 couples): • Donor sperm insemination: in protocol 2 :32-34 h after infection of 

hCG; in protocol 3: 38-40 h after injection of hCG 

• Sperm preparation: • -swim-up technique in (n=11) • -sperm WASH in (n=25) • -density gradient in (n=8) • -sperm incubation in (n=8) • Intrauterine insemination: In Protocol 1: 24 h after LG surge detection

in non-stimulated cycles (self-monitored by pts); IVF in (n=1)

• P

raprprouprprouprpr

• Li

(n

• F

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = spemotility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; R

E-45
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Fo

Rawicki, 

1991, 

Australia 

(Ref ID 

655) 

• Enrolled/evaluat

ed: n=39 SCI (& their partners)/ n=38 

• % male: 50% of

couples 

• Race/ethnicity:

NR 

• Age: NR • Level of Injury: 

n=35 C4-L5 

• ASIA Level: NR • Duration since 

injury: NR 

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: • N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: 5 y

• Eligibility Criteria: • Inclusion: Pts recruited 

since 1985

• Exclusion: NR • Quality Assessment:

7/19 (+) reported 

• Pharmacologic: • Drug name: physostigmine (SP) following admin. 

of an peripherally actin anticholinergic agent i.e. Buscopan (40 mg i.m.) tx of side effects: “ Labetolol 100mg p.o. or Nifedipine 10 mg p.o. 30 m prior to EJ in event of autonomic dysreflexia (in all C7 or above when BP>40/30; systolic BP>150)” 

• Dose SP: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: combined with ES/VS• Device: Electrical stimulator 

• Amplitude: 30 V • Frequency: 10 Hz • Mode/Admin. Route: through a rectal probe, to 

stimulate sympathetic nerves to seminal vesicles & ampulla of vas deferens causing semen emission 

• Other Device: Vibrator 

• Frequency: 80 Hz • application: glans of frenulum • Mode/Admin. Route: in combination with ES & SP • Surgical: NR • Procedure: NR 

• Behavioural: • Type: masturbation • Duration: NR • Frequency: NR• Laboratory techniques:• IVF & donor egg (n=1)

• Outcomes: • Measures of 

Rates: 

• EJ Rates: Hig

chance of obtsemen in men lesions at T8 above: AG in RG in (n=3); iSCI T10-12 salso obtained 

• Pregnancy ra

pregnancies icouples 

• Follow-up: N

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-46
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-47

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Rutkowski, 

1995, 

Australia 

(Ref ID 

959) 

• Enrolled/evaluate

d: n=70/ n=70 

• % male: 100 %• Race/ethnicity:

NR 

• Age: 30 (19-59) y• Level of Injury: 

n=36 C1-C8; n=19 T1-T9; n=15 T10-L2 

• ASIA Level: NR • Duration since 

injury: 6 (3 mo2) y

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: data collection period: 

1988-1994 

• Eligibility Criteria: • Inclusion: SCI pts assessed 

between 1988-1994 at Royal North for enhancement/fertilityissues 

• Exclusion: NR • Quality Assessment: 9/19 (+) 

reported 

• Pharmacologic: NR 

• Device: Electrical stimulator 

(n=34) 9/34 failed to ejaculate with VS 

• Amplitude: voltage of 22-30 • Frequency: 10 or 50 Hz • Mode/Admin. Route: 3 cycle for 

duration of 45 s 

• Other Device: Vibrator (n=36)

• Type: NR • Mode/Admin. Route: 3.5 m 

stimulation with 1 m rest repeated 3 times for lesions above T10 

• Surgical: NR 

• Procedure:

• Bladder catheterization: 3 

techniques: Clean intermittentself-catheterization (CISC); indwelling urethral catheter (IDC) or suprapubic catheter (SPC); drainage without acatheter (i.e. voiding by reflex or staining) 

• Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: 

• Measures of Fertility • Seminal Parameters

Neurological level (p& method of bladder management (p<0.0found to be S predicpresence or absencspermatozoa in samdf between catheters catheter grp across neurological levels (9, & T10 & below) 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-48

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Sarkarati, 

US, 

1987 

(Ref ID 

985)

• Enrolled/evaluate

d: n=34/ n=34 

• % male: 100 • Race/ethnicity: NR • Age: 16-36 y • Level of Injury: 

n=14 C5-6; n=13 T1-9; n =7 T10-L3 

• ASIA Level: NR • Duration since 

injury: (n=11)<6 mo 

• Previous fertility: 

NR 

• Dropouts: n=5 • Lost in follow-up: • N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: 5 y

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

10/19 (+) reported 

• Pharmacologic: NR 

• Device: Vibrator (n=33) 

• Amplitude: 1.6-2.4 mm for 

3.5 m on, 1.6-2.4 off 

• Frequency: 80Hz • Mode/Admin. Route: max of 

3-4 cycles 

• Other Device:

Electrostimulator (n=26) 

• Type: Soft silicone glove 

finger 

• Manufacturer: C.M. & rew

43 L&croft Rd, London, Engl. 

• Amplitude: 80-90 V • Frequency: 15/30 cycle/sec • Mode/Admin. Route: pain 

prevented ES in (n=4) (Brindley’s technique) 

• Surgical: NR 

• Procedure: NR

• Behavioural: NR • Laboratory techniques:

NR 

• Outcomes: 

• Measures of Fertility Rates: • Seminal Parameters: AG sem

VE in (n=7) & from EEJ in (nSpC range 0-250 mln/mL; Sevolume, range 1cc to 7cc in V0.5-5 cc in EE; Normal Morpranges 7-250 mln in VE vs. 8in EE 

• EJ Rates: VE (n=33) resulted 

7 & RG in 1; EEJ resulted in & RG in 9 of 22. No responsor EEJ obtained in 5 of 34 & prohibited EEJ. 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-49

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-u

Siösteen

1990, 

Sweden

(Ref ID 

979) 

• Enrolled/ evaluated: 

n= 32/ n=33 

• % males: 100%• Race/ethnicity: NR • Age (mean & range of 

male & partner) 

• Level of Injury: C4-L1 • ASIA Level: NR • Duration since injury: 

2 (1-23) y 

• Previous fertility: NR • Drop-outs: n=6 • Lost to follow-up: NR • Number of sites: 1 • Funding: grants from 

Norrbacka-Eugenia Foundation; National Association of People Disabled by Road Accidents; Poliomeyelitis; Ted SöderlundFoundation; Greta & Einar Asker Foundation

• Study Design: NCS 

• Duration: 6 ms 

• Eligibility Criteria: • Inclusion: NR • Exclusion: injury <6 mo • Quality Assessment: 11/19

(+) reported 

• Pharmacologic: NR • Device: Vibrator (Relax/Ling 

201) (n = 29) 

• Amplitude: 1.5 mm/ 2.5 mm • Frequency: 100 Hz/ 80 Hz • Mode/Admin. Route: 3.5 m 

VS -1.5 m rest 

• Other Device:

Electrostimulator (n=3) 

• Type: NR • Voltage: up to 80 V • Frequency: 15-30 Hz • Mode/Admin.: obturator 

nerve site , ES continued for up to 40 sec 

• Surgical: NR 

• Procedure: NR

• Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: • Seminal Parameters:4-6 m

wkly VS in 16/22 pts with Aresulted in a rise of semen & of fructose & acid phosplevels in seminal plasma, suggesting improved functseminal vesicles & prostatepenetration capacity (SPCstrong evidence of long terstimulation effect (normal Spts pre- tx vs. 11 pts post-

• EJ Rates: AG in 22/32, RG 

no EJ in 3 pts 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-50

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Fo

Sonksen, 

1994, 

Denmark 

(Ref ID 

327) 

• Enrolled/evaluated: 

n=66: Population I n=25; Population II n=41/ n=66 

• % male: 100 %• Race/ethnicity: NR • Age: Population I: 

27 (19-42) y,Population II: 29 (18-44) y

• Level of Injury: Pop I 

- C3-L1, Pop II - C2-L1:(total of n=44with complete lesion) 

• ASIA Level: NR • Duration since 

injury: Pop I: Range 0.6-39 y, Pop II: Range 0.2-27 y 

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: NR 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 9/19 (+) 

reported 

• Pharmacologic (n=9): 

• Drug name: glycerine nitrate • Dose: 0.5 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: 

sublingually

• De

vice: Vibrator A 

• Amplitude: 0-10 mm peak to 

peak 

• Frequency: 0-120 Hz • Mode/Admin. Route: vibrator

held steady against frelunum for max of 3 m & 1 m rest. Cycle repeated for max of 6 times (6 cycle completed for all 

pts) 

• Other De

vice: Vibrator B 

• Amplitude: 1.5 mm peak to 

peak 

• Frequency: stationary at 100 

Hz 

• Mode/Admin. Route: same as

vibrator A 

• Surgical: NR • Proc

edure: NR

• Beha

vioural: NR 

• Laboratory techniques: NR 

• Outcomes: 

• Measures of Fertil• Seminal Paramete• EJ Rates: in (n=58

(88%): AG respon62%, RG respons26%, no EJ in (n=relation bet

ween l

lesion, completenstimulation time reobtain AG EJ. No bet

ween EJ respo

completeness of cage or y since les

• Foll

o

w-up: NR 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = EJ; SpC = sperm count; 

sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retrograde 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other)

O

F

Sonksen, 

1997, 

Denmark 

(Ref ID 

531) 

• Enrolled/evalu

ated: n=28 couples/ n=28 couples 

• % male: 50 % 

of couples 

• Race/ethnicity

: NR 

• Age: men: 

31(24-42) y, female partners: 29 (19-39) y

• Level of Injury: 

C2-L4; (n=26 above T10) 

• ASIA Level: 

NR 

• Duration since 

injury: 8 (1-22) y

• Previous 

fertility: NR 

• Dropouts: n=0 

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent:

9/19 (+) reported 

• Pharmacologic: 

• Drug name: (SCI >T6) nifedipine • Dose: 10 mg • Duration: NR • Schedule: 15 m pre PVS & EEJ • Mode/Admin. Route: 15 m prior to PVS or EEJ (prevention of 

autonomic dysreflexia) 

• De

vice: Electrostimulator 

• Amplitude: max voltage 30 V• Frequency: 600 mA • Mode/Admin. Route: median total n of 20 sti

mulation (range, 16-

28) 

• Other De

vice: Vibrator 

• Frequency: N

R

• Mode/ Admin. Route: stimulation periods of up to 3 m & 2 m rest 

for up to 6 cycles 

• Surgical: NR 

• Proc

edure: 

• Bladder catheterization • with 10 mL of a sperm-friendly medium via a 14 F silicone 

catheter pre/post EEJ 

• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR • Beha

vioural: NR

• Outco

• Meas

Rates

• Semin

total Smln, rmln; sconce43 mlmln; S13%, Sperm morp34%, 

• EJ Ra

PVS 

• Pregn

35.7% 

• Misca

none 

• Induc

none 

• Live B• Single

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-51
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other)

O

F

Sonksen, 

1997, 

Denmark 

(cont’d) 

(Ref ID 

531) 

• Lost in followup: NR • N of sites: 1 • Funding: NR 

• See above • Laboratory techniques:

• Donor sperm insemination • Sperm preparation: NR • Intrauterine insemination: in (n=3); 38 h following hCG injection. 

In these cases clomiphene citrate admin. 50-100 mg /d, on d 3 to 7 of cycle 

• IVF: in (n=1) treated with gonadotropin-releasing hormone (GnRG) analogue buserelin, followed by stimulation of human

menopausal gonadotropins 

• Intracytoplasmic sperm injection; in 2 (drug admin. as IVF)• Self-insemination: in (n=4) 

• Multip

twins

• Follow

couplhome self-inFour achiewith dbabie

• Lengt

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-52
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 1: Non-comparati

ve case series studies of fertility rates in pts 

with spinal cord injury (cont’d) 

E-53

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

Ta

ylor, 

1999, 

Australia 

(Ref ID 

500) 

• Enrolled/evaluated: 

n=19 couples/ n=19 couples 

• % male: 50% of

couples 

• Race/ethnicity: NR • Age: NR (24-44) y• Level of Injury: n=9 

C4-C6; n=10 T4-T12/L1 

• ASIA Level: NR • Duration since 

injury: 9.3 (1-24) y

• Previous fertility: 

NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

7/19 (+) reported 

• Pharmacolo

gic: NR 

• De

vice: Vibrator (n=19) 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR • Oth

er De

vice: Electrostimulator (n=10) 

• Type: NR • Manufacturer: NR • Surgical: NR • Proc

edure:

• Bladder catheterization • -with instilling of 20 mL phosphate buffered 

Tyrode tissue culture medium pre EEJ 

• Epidydimal aspiration (MESA/PESA): NR • Testicular biopsy: NR 

• Beha

vioural: NR 

• Laboratory techniques:• Donor sperm insemination • Sperm preparation • - wash in (n=14) • - DG in 15 • Intrauterine insemination: (1st tx) in 15 

couples by daily monitoring of serum LE hormone; multiple attempts in all but 1 

• IVF & embryo transfer: in cases with poor 

SpC (n=1) 

• Intracytoplasmic sperm injection: in 8 

couples other methods had failed due poor sperm quality. 

• GIFT: (2nd choice) in 7 couples

• Outco

mes: 

• Measures of Ferti

Rates: 

• Seminal Paramet

SpMot recorded aSCI period of 1-24 consistently lo

w 1

SCI 

• Pregnancy rates: 

cycle in pts havingIntrauterine insem12% (11/92); gamFallopian transfer (8/18); intracytoplsperm injection 19(5/21). Success rahigher in SCI ≥ 10 

(87%) compare to 22% in SCI ≤ 10 y

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

E-54

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

VerVoort, 

1988, US 

(Ref ID 

982) 

• Enrolled/evaluated: 

n=7/ n=7 

• % male: 100%• Race/ethnicity: NR • Age: 29 (21-38) y• Level of Injury: C4-

C7 

• ASIA Level: A-C(no 

designation) 

• Duration since 

injury: 8.8 (0.5-19) y

• Previous fertility: NR • Dropouts: n=1 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NIDRR & 

PMRERF 

• Study Design: NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: BP elevation during

EEJ 

• Exclusion: NR • Quality Assessment: 10/19

(+) reported 

• Pharmacologic (n=6): 

• Drug name: Nifedipine• Dose: 10 mg • Duration: NR • Schedule: 10-15 m pre EEJ • Mode/Admin. Route: NR • Device: Electrostimulator (n=6) 

• Amplitude: without medication

125-300 mA; with medication: 175-500 mA 

• Frequency • Mode/Admin. Route • Other Device: NR 

• Surgical: NR • Procedure: NR

• Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: • Measures of Fertility • EJ Rates: Repeat EE

attempts performed awks apart. EEJ (AG o3 of 9 (33%) without nifedipine, & 19 of 22 with nifedipine 

• Additional Outcome: 

increase in mean macurrent delivered withnifedipine (367±112) with nifedipine 172±6(p<0.05); Increase in delivery resulted in gsuccess at sperm co

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = mgrp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volt

treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; e

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sp

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = ret

on Disability Research & Rehabilitation; EEJ = electro ejaculation; BP = blood pressure; PMRERF = Physical Medicine & Rehabilitation 
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

Author, 

Year, 

Locatio

n 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Wang, 

1992 

Taiwan

(Ref ID 

973) 

• Enrolled/ evaluated: 

n=25/ n=25 

• % males: 100%• Race/ethnicity: NR • Age : 31(19-43) y• Level of Injury: C5-T12 

(all complete) 

• ASIA Level: NR • Duration since injury: 6 

(0.3-14) y

• Previous fertility: NR • Drop-outs: n=0 • Lost to follow-up: NR • Number of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: Aug 1990- May 1991, 

prospective study

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: 11/19 (+) 

reported 

• Pharmacologic: NR • Device:

Electrostimulator(Seager Model) (n = 25) 

• Amplitude: 434±54 mA/ 

21.7±2.7 V(15-25 V) 

• Frequency: max of 60 

stimulations 

• Mode/Admin. Route: rectal 

probe; left lateral ducubitus position 

• Other Device: NR 

• Surgical: NR • Procedure (n=25): 

• Bladder catheterization • -with/without alkalinization: 

blastic catheter & instillation with 20 mL ham’s F-10 solution 

• Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: NR • Behavioural: NR 

• Laboratory techniques: NR 

• Outcomes: • Seminal Parameters

<5% in most cases; nspermatozoa in 6/21correlation in sperm qquantity with method bladder managemenlevel of injury or injurimproved sperm ana14/21 in later attemp

• EJ Rates: 21/25; RG 

pure AG in 9/21; 

• Infection rates: all pts 

least one episode/yr 

• Follow-up: • Length: wkly stimulat• Duration: NR • Results: in 19 occasi

weekly ES resulted indeterioration of sperm (SpC reduction of 52total motile SpC redu61± 27%)

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = volts; Hz = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enr

analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = ejaculation; SpC = sperm 

SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; AG = antegrade; RG = retr

E-55
Appendix E. Evidence Tables (continued)

Evidence Table 1: Non-comparative case series studies of fertility rates in pts with spinal cord injury (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility Criteria/ 

Quality Assessment 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Warner, 

1986, US 

(Ref ID 

1339) 

• Enrolled/ evaluated: 

n=31/n=31 

• % males: 100% • Race/ethnicity: NR • Age: NR • Level of Injury: T2-L3 • ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Drop-outs: (n=9) 

intolerant to ES 

• Lost to follow-up: NR • Number of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: 3/19 

(+) reported 

• Pharmacologic: NR • Device: Electrical stimulator 

Model 3(n = 31) 

• Amplitude: NR• Frequency: up to 100 Hz • Current: 160-200 mA (0.29-

0.36 mA/mm2)

• Mode/Admin. Route: rectal 

probe ES; semen collected byFoley catheter

• Other Device: NR 

• Surgical: NR • Procedure: NR

• Behavioural: NR 

• Laboratory techniques: NR

• Outcomes: • Measures of Fertility

Rates: NR 

• Seminal Parameters: NR • EJ Rates: 22/31 tolerated 

current of 160-200 mA sufficient to induce erection; 14/22 AG; 7/22 RG only; 9/22 RG+AG (2/22 no emission) 

• Erection: 2/22 no erectio

with emission; 1/22 erection with no emission & 1/22 produced neither; 16/22 produced both erection& emission. 

• Pregnancy rates: NR • Live Births: NR• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mA = milliamphere; mg = milligrams; μg = microgram; V = v

millions; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of paqualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+) = positive; (-) negative; A/E = adverse event; EJ = count; SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilizat

= retrograde 

E-56
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients 

with SCI. 

E-57

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/Device/ 

Beha

vioural/Surgical/Other)

Outco

m

es/F

ollo

w-up

Brackett, 

1994, US 

(Ref ID 

1208)

• Enrolled/ evaluated: total 

(n=107): SCI n=66; ctrl n=21, non-injured normospermic men; noninjured infertile n=20/ n=NR 

• % male: 100%• Race/ethnicity: NR • Age: SCI 30.8 (19-47) y;

non-injured. normospermic 26.5 (19-40) y; non-injured. Infertile34.2 (29-40) y

• Level of Injury: 36% 

cervical, 56% thoracic, 8% lumbar, 39% quadriplegic (incomplete), 61% paraplegic (43% complete, 57% incomplete) 

• ASIA Level: NR • Duration since injury: 8.1 

(1-25) y

• Study Design:

Case-control Study 

• Duration: NR • Eligi

bility Criteria: 

• Inclusion: healthy• Exclusion: presence 

or absence of pyuria

• Quality

Assessm

ent: 7 * 

(NOS) 

• Pharmacolo

gic: NR

• De

vice: (Vibrator Oster) (SCI 

n=66) 

• Amplitude NR • Frequency NR• Mode/Admin. Route: 5 m 

vibration & 1 m rest; repeated if no EJ occurred

• Oth

er De

vice (SCI n = 66):

• Type: Electroejaculator • Manufacturer: NR • Surgical: NR• Proc

edure (SCI n=66): 

• Bladder catheterization 

with/without alkalinization 

with 

25-50 mL sperm 

washing 

medium added to bladder

• Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: NR • Beha

vioural (ctrls n=41): 

• Type: masterbation • Duration: NR • Frequency: N

R

• Outco

mes: 

• Measures of Fertility Rates: • Semen analysis: SpC, SpMot & 

normal SpMor (AG & RG in S

C

in non-injured infertile & normospermic grps.). SpC: lo

w

counts in IC (57.1: 0-75 mln) vs(231. 0-1 billion)(p < 0.01), & to (231.7: 19 mln to 1 billion)(p < SpMot: S higher % of SpMot in (59.6: 4.6 %, range: 20-92 %) v(27.2 +/- 3.7 %, range: 1-70 %)0.0002), & also vs. IC (26.6 +/- range: 20-90 %)(p < 0.0005). SS dfs in SpMor in SCI & NC: SC+/- 3.5 %, range: 20-88 %) vs. (70.7 +/- 2.0 %, range: 56-89 %<0.05). No S df bet

ween mean 

in SCI & IC or I

C & NC 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minut

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histor

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = sperm 

vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-58

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/Other) Outcomes/Follow-up

Brackett, 

1994, US 

(cont’d) 

(Ref ID 

1208)

• Previous fertility: infertile 

pts (n=20): abnormal semen analysis due to varicocele, testicular failure, ejaculatorydysfunction & idiopathic infertility. 

• Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: Miami Project to 

Cure Paralysis

• See above • Laboratory techniques

(n=107): 

• Measurement of serum levels

of hormones byradioimmunoassay using Amerlex LH radioimmunoassay kit or bymicropartical enzymeimmunoassay IMX system (ref range: 4-23 mIU/mL)

• Additional outcomes: Inciden

endocrine outliers: 42% of SCI or more hormone outliers. Incidof outliers in SCI of T8 & T10 svs. SCI of other levels (C1 to C0.01, T1 to T7 - p < 0.01, & T11 p< 0.05) - In SCI, SpC slightly inversely correlated to levels of = -0.400, p < 0.02) – IC pts withelevated FSH had SpCs rangin0 to 5 mln; Hormone levels: LH in SCI (22.1 +/- 2.8 %) slightly than IC (23.3 +/- 4.8 %)(p < 0.0NC (33.0 +/- 4.5 %), mean did differ from SCI & IC. 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minut

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = two times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = sperm vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients 

with SCI (cont’d).

E-59

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/Device/ 

Beha

vioural/Surgical/Other)

Outco

m

es/F

ollo

w-up

Brackett, 

1994, 

US 

(Ref ID 

1185) 

• Enrolled/ 

evaluated: n=87 (SCI n=66, nonSCI, ctrl n=21)/ n=87 

• % male: 100%• Race/ethnicity:

NR 

• Age: SCI 30.8 

(19-47) y; ctrl 26.5 (19-40) y

• Level of Injury: 

36% cervical, 56% thoracic, & 81% lumbar 

• ASIA Level: NR • Duration since 

injury: 8.1 (1-25) y

• Previous fertility: 

NR 

• Dropouts: (n=24) • Lost in follo

w-up: 

• N of sites: 1 • Funding: Miami 

Project to Cure Paralysis 

• Study Design: Casecontrol Study • Duration: 25 mo • Eligi

bility Criteria: 

• Inclusion: good general 

health in SCI & ctrl no hx of fertility problem SCI >1y post-injury 

• Exclusion: NR • Quality Assessment: 8 

* (NOS) 

• Pharmacolo

gic: NR 

• De

vice: (Vibrator & 

Electrostimulator in (n=66)

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: VS: in 

seated position, applied to penis for 5 m if no EJ, 1 m rest & resumed for additional5 m 

• Other De

vice (n=87): 

• Type: Diatek Model 600/ 

digital oral & scrotal 

temperature measurements 

• Manufacturer: NR • Surgical: NR • Proc

edure: 

• Bladder catheterization • -with/out alkalinization in all 

SCI using 25-50 mL of sperm washing medium. 

• Beha

vioural: 

• Type: self-masturbation 

follo

wing 3-7 d of abstinence 

• Outco

mes: 

• Measures of Fertility Rates: • Semen analysis: Total SpC simila

SCI & ctrl (mean +/- SEM: 278.9 (67.4) (range: 19.2 mln - 1.1 mln) 231.4 (53.9) (2.3 mln - 2.0 mln), respectively. Mean SpMot slightlylo

wer in SCI (13.7) (0-55 %) vs. c

(61.3) (20-92%); % of normal formper ejaculate. Slightly lo

wer in SC

(47.2: 20-72%) vs. ctrl (72.4) (56-94%); NS dfs in SpC, SpMot, SpMin To, Ts, 

Td (

Oral minus Scrotal) 

each grp. In each grp, To, Ts & 

Td

each related to serum LH & F

SH 

levels no S; Not generalized scrotthermoregulatory dysfunction in Smen, scrotal temperature not appto contribute to poor semen qualitSCI men & elevated gonadotropin levels not related to elevated scrotemperatures in SCI men, as repoin non-injured, infertile men. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = 

vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-60

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/Other) Outcomes/Follow-up

Brackett, 

1994, 

US 

(cont’d) 

(Ref ID 

1185)

• See above • See above • Laboratory techniques

(n=66):

• Donor sperm insemination: 

NR 

• Sperm preparation: NR 

erum hormone measured by

radioimmunoassay (RIA) using Amerlez LH RIA kit or microparticle enzymeimmunoassay (MEIA) using IMx system.

• See above 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = 

vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients 

with SCI (cont’d).

E-61

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/Device/ 

Beha

vioural/Surgical/Other)

Outco

m

es/F

ollo

w-up

Brackett, 

1997 

US 

(Ref ID 

1135)

• Enrolled/ evaluated: 

total n=19; SCI n=10; ctrl n=9/ n=19 

• % male: 100%• Race/ethnicity: NR • Age: SCI 33.1 (2.9) y;

healthy ctrl 30.3 (1.8) y

• Level of Injury: C4-C5 

(n=5), T5-T6 (n=4), T12 (n=1) 

• ASIA Level: NR • Duration since injury: 1 

(2.4) y

• Previous fertility: no hx

of infertility in ctrl grp 

• Dropouts: n=0 • Lost in follow-up: n=19 • N of sites: 1 • Funding: State of 

Florida SpecificAppropriation No. 610 for Spinal CordResearch; Mia

mi Project 

to Cure Paralysis 

• Study Design: Casecontrol Study • Duration: NR • Eligi

bility Criteria: 

• Inclusion: no medication 

kno

wn to affect semen 

quality taken 

within 6 

mo prior to study; SCI grp > 1 y post injury

• Exclusion: NR • Quality Assessment: 

8 * (NOS)

• Pharmacolo

gic: NR 

• De

vice: Vibrator (n = 4)

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR • Oth

er De

vice (n=6):

• Type: Electrostimulator • Amplitude: starting at 1 V & 

increased to an average of 10 V 

• Surgical (n = x): NR 

• Penile Implants • Procedure (n=x): NR 

• Bladder catheterization • -with/

without alkalinization: N

R

• Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: NR • Beha

vioural (ctrl n=9): 

• Type: masturbation following 3-7 

d of abstinence

• Duration: NR

• Frequency: N

R

• Laboratory techniques (n=19): • Sperm preparation: 15-20 m 

liquification of semen at roomtemperature. SpMot & viability at time of 0. Specimens then divided into 2 aliquots, 1 at room temp. (23oC) & 1 at body temp. (37oC). 

SpMot & viability for each at 2, 4, 6 & 8 hrs after time 0) 

• Outco

mes:

• Measures of Fertility Rate

Semen analysis: Effect of 

temperature on sperm characteristics baseline & % decrease in SpMot: S > decrease in SpMot in specimens from SCI vs. ctrat 4, 6 & 8 hrs vs. time 0. S dfs at all time points at incubated temp. Heat did naffect rate of degradation in motility in ctrl specimens bhastened degradation inmotility in speci

mens of SC

% decrease in rapid linear SpMot: S > decrease in raplinear motility in specimens from SCI vs. ctrls at 6 & 8 hafter collection at room tem& at all time points at incubated temp. Heat did nslightly affect rate of degradation in rapid linear motility in ctrl specimens. Hhad S effect on specimens from SCI. Decrease in rapilinear motility by 50

%

withi

first 2 hrs, & by 8 hrs 0% ralinear SpMot

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = 

vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Ne

wcastle Ottawa Scale; V = volt 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients 

with SCI (cont’d).

E-62

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/Device/ 

Beha

vioural/Surgical/Other)

Outco

m

es/ Follo

w-up

Hirsch, 

1991, US 

(Ref ID 

976) 

• Enrolled/ evaluated: 

n=29: SCI n=14; ctrl n=15/ n=29 

• % males: 100%• Race/ethnicity: NR • Age: SCI 28.4 (17-42) 

y; ctrl 36 (29-51) y

• Level of Injury: 

cervical, thoracic, lumbar (not specific) 

• ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: SCI 

2/14 previous pregnancies pre-injury

• Drop-outs: n=0 • Lost to follo

w-up: 0 

• N of sites: 1 • Funding: Regional 

Spinal Cord InjuryCenter of the Dela

ware Valley; 

NIDRR 

• Study Design: Casecontrol study • Duration: 4-6 mo • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 7 * 

(NOS)

• Pharmacolo

gic: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: • Biopsy • Proc

edure (n=14): 

• Bladder catheterization; NR • Epidydimal aspiration

(MESA/PESA): NR 

• Testicular biopsy: in n=14 tubular 

diameter & tubular 

wall thickness 

measured by A

O fialr micrometer 

eye pieces (Model 426B) 

• Beha

vioural: NR 

• Laboratory techniques:• Donor sperm insemination • Sperm preparation (s

wim-up & 

discontinuous gradient 

• Intrauterine insemination • IVF • Intracytoplasmic sperm injection • Embryo cryopreservation • Sperm cryopreservation: 

ejaculated & biopsy 

• Outco

mes: 

• Measures of Fertility Rates: • Seminal Parameters: SCI pt

sho

wed S lo

wer mean SpC 

higher Sertoli cell count vs. c(p<0.05). No df in either meainternal tubular diameter or tubular 

wall thickness noted

correlation between tubular thickness & mean sperm or Sertoli cell count for either gSertoli cell-to-spermatid ratio for SCI grp (p<0.0001). WithSCI grp neither micrometric parameters nor Sertoli cell-tosperm ratio showed any relationship to level, durationdegree of injury. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm motility; SpMor = 

vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = luteinizing hormone; retrograde; mln = millions; NOS = Newcastle Ottawa Scale; NIDRR = National Institute of Disability Research & Rehabilitation 
Appendix 

E. Evi

dence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients 

with SCI (cont’d).

E-63

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eli

gibility

Criteria/Quality

Assessm

ent 

Intervention 

(e.g., Pharmacologic/Device/ 

Beha

vioural/Surgical/Other)

Outco

m

es/F

ollo

w-up

Hirsch, 

1994, US

(Ref ID 

965) 

• Enrolled/evaluated: 

n=16: SCI n=10,vasectomized men n=6/ n=16

• % male: 100%• Race/ethnicity: NR • Age: 30.1 (5.2) y;

ctrl 37.2 (6.7) y

• Level of Injury: NR • ASIA Level: NR • Duration since 

injury: 6-8 y

• Previous fertility: 

n=6 vasactomized men (mean interval for vasectomy (8.8) y 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: Regional 

Spinal Cord InjuryCenter of the Dela

ware Valley; 

NIDRR 

• Study Design: Casecontrol Study • Duration: NR • Eligi

bility Criteria: 

• Inclusion: ctrl grp: 

within 

range of age & duration since presence of outcome (infertility) to SCI grp, no hx of infertility 

• Exclusion: NR• Quality Assessment: 4 

* (NOS)

• Pharmacolo

gic: NR

• De

vice: NR 

• Oth

er De

vice : NR 

• Surgical: NR • Proc

edure (n=16):

• Testicular biopsy: 10 randomly

selected round seminiferous tubules analyzed, & mean tubular thickness measured from photomicrographs obtained after magnification with enlargement of 

print. 

• Histometric values: mean 

concentration of late spermatids /tubule; mean ratio of spermatids to Sertoli cells /tubule; tubular 

wall 

thickness 

• Beha

vioural: NR 

• Laboratory techniques:• DNA flo

w cytometric analysis 

• Outco

mes: 

• Measures of Fertility Rates: • Biopsy results: SpMot & 

viability measured at 0, 2, 4& 5 hrs after semen collectiBoth anatomical & functionobstruction of male genital tract exerts similar spermatogenic insult. In bocause of neurogenic infertilis more likely to be at posttesticular level.Spermatid/Sertoli cell ratio S df bet

ween grps. Similar 

values for tubular 

wall 

thickness noted in both grpNo S dfs bet

ween grps in % 

haploid, diploid & tetraploid cells. Mean % of haploid cein tissue of vasectomized(54.2%) & SCI (47.4%) men comparable 

• Foll

o

w-up: NR 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; (-) = negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm mo

morphology; V

S = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = lut

antegrade; RG = retrograde; mln = millions; NOS = Newcastle Ottawa Scale; NIDRR = National Institute of Disability Research & Rehab
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-64

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/Other) Outcomes/Follow-up

Hou 

1995, 

US 

(Ref ID 

1180)

• Enrolled/evaluated: 

n=116: SCI n=12; nonSCI n=104/ n=NR 

• % male: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Dropouts: NR • Lost in follow-up: NR • N of sites: 1 • Funding: Dr. Ralph & 

Marion C. Falk Medical Trust 

• Study Design: Casecontrol Study 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

5 * (NOS)

• Pharmacologic: NR

• Device: Vibrator

• Amplitude: NR• Frequency: NR• Mode/Admin. Route: NR • Other Device: NR

• Surgical: NR

• Procedure: NR

• Behavioural (n = 104): 

• Type: self- masturbation • Duration: NR 

• Frequency: NR

• Laboratory techniques

(n=116): 

• Sperm preparation: Aniline 

Blue Staining 

• Outcomes: 

• Measures of Fertility Rates: • Semen analysis: % SpMot & % 

normal SpMor from SCI (36.5 +/- 6.8, 44.0 +/- 2.4) men slightlypoorer than those from non-SCI men 70.5 (1.2), 50.8 (0.7) (p <0.01); % of spermatozoa unstained by Aniline Blue not slightly different in non-SCI men 83.4 (1.1 %) vs. SCI men 79.7 (4.8 %) 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; (-) = negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm mo

morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = lu

antegrade; RG = retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-65

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality

Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/ Follow-u

Martin 

1983, 

US 

(Ref ID 

1406) 

• Enrolled/evaluated: 

n=20: SCI n=8; ctrl n=12/ n=20 

• % male: 100%• Race/ethnicity: NR • Age: SCI NR (24-41) 

y; ctrl NR (23-26) y

• Level of Injury: T3-T12 

(n=3) T12-L1 (n=2) L2 n=1 

• ASIA Level: NR • Duration since injury: 

(1-20) y

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NIMH

• Study Design: Casecontrol Study 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 4 * 

(NOS) 

• Pharmocologic: NR

• Device: Rectal Probe

Electrostimulator

• Amplitude • Frequency: 60 Hz, 20 Hz, & 0.25 

Hz 

• Mode/Admin. Route: dorsal 

lithotomy position (after bowelmovement) intact subjects & 1st 5 pts controlled current delivery bythemselves 

• Other Device: NR • Surgical: NR • Procedure: NR

• Behavioural: NR 

• Laboratory techniques: NR

• Outcomes: 

• Measures of Fertility Rate• Erection: Erection elicited 

repeatedly in only 1 of intpts, & no seminal emissioEJs occurred. Use of 60 H20 Hz currents ineffective eliciting erection & mean maximally tolerable currelevel for these frequencierespectively, 29mA & 29 Repositioning of probe ineffective in initiation of erection during stimulatio

• Follow-up: NR 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; (-) = negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm mo

morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = lu

antegrade; RG = retrograde; mln = millions; NOS = Newcastle Ottawa Scale; Hz = hertz; mA = milliamps; NIMH = National Institute of M
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-66

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/ Follow-up

Monga, 

2001, US 

(Ref ID 

947) 

• Enrolled/evaluated: 

7 SCI; 5 ctrls/NR

• % males: 100%

male 

• Race/ethnicity: NR • Age: (27-54) y • Level of Injury: all 

cervical (n=5 incomplete lesion) 

• ASIA Level: NR • Duration since 

injury: (5-31) y 

• Previous fertility: NR • Drop-outs: n=0 • Lost to follow-up: 0 • N of sites: 1 • Funding: American 

Paraplegia Societygrant 

• Study Design: Case-control 

Study

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 5 * 

(NOS) 

• Pharmacologic: NR 

• Device: FERTI CARE Vibrator

(6/7 SCI) 

• Amplitude: 2.5 mm • Frequency: 100 Hz • Mode/Admin. Route: NR • Other Device: NR 

• Surgical: 

• Penile Implants • Procedure (n=7): 

• Bladder catheterization • - without alkalinization • Behavioural (n = 5 ctrl, n=1 

SCI): 

• Type : masturbation • Duration: NR • Frequency: NR• Laboratory techniques: NR

• Outcomes: 

• Seminal Parameters: 

Semen samples from mewith SCI showed azoospermia (n=3) & sevasthenospermia (n=2). Majority (65%) of sperm from asthenospermic samples showed degenerative ∆s & S axonemal defects. Incubation of normal spewith SCI seminal plasma induced concentrationdependent decrease inSpMot (43%) accompanby S drop in intracellular ATP content (33%). 

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; (-) = negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm mo

morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = lu

antegrade; RG = retrograde; mln = millions; NOS = Newcastle Ottawa Scale; Hz = hertz 
Appendix E. Evidence Tables (continued)

Evidence Table 2: Case-control studies of fertility rates in patients with SCI (cont’d).

E-67

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/ Follow

Padron 

1994 

US 

(Ref ID 

1197) 

• Enrolled/ evaluated: 

n= 19: SCI n=9; ctrl n=10/ n=19 

• % male: 100%• Race/ethnicity: NR • Age: SCI 30.2 (1.2) y;

ctrl 24.3 (3.6) y

• Level of Injury: NR • ASIA Level: NR • Duration since injury: 

mean: 6.2 (1.1) y

• Previous fertility: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: Miami 

Project to Cure Paralysis 

• Study Design: Case-control 

Study

• Duration: NR • Eligibility Criteria: • Inclusion: good health >1 y

post injury

• Exclusion: NR • Quality Assessment: 4 * 

(NOS) 

• Pharmacologic ( in SCI grp): • Drug name: nifedipine• Dose: 30-40 mg• Duration: NR • Schedule: 15 m pre EJ in SCI • Mode/Admin. Route: in SCI with hx

or autonomic dysreflexia 

• Device: Vibrostimulator (n=5) • Amplitude: NR• Frequency: 5 m vibration, repeated

if no EJ occurred for 2nd 5 m after 1 m rest period EJ 

• Mode/Admin. Route: on frenulum 

on dorsal aspect for 5 m 

• Other Device: Electrical 

Stimulator (n=4) 

• Type: Seager Model 12 • Manufacturer: National Rehab

Hospital, Washington D.C. 

• Surgical: NR • Procedure: NR

• Behavioural (n = 10): • Type: masturbation • Duration: NR • Frequency: NR• Laboratory techniques (n = 19): • Sperm cryopreservation: EJ done 

for all ejaculated samples / freezing using Vapor only; Vapor + liquid nitrogen & liquid nitrogen only. 

• Outcomes: 

• Measures of Fertility R• Semen analysis: Mean 

SpMot in fresh & thawesamples for each methfreezing in SCI S lowectrl pts; mean % SpMoSCI: 17+/-6.8 mln vs. 25.4 mln in ctrls (p, 0.05drop in SpMot after frenot S different in SCI & pts. Freezing by Vapor superior for retention omotility vs. other methofreezing. For ctrl pts mdrop in motility S less wVapor only vs. two othemethods (<p=0.05 & p<0.002). % of sperm rapid linear motility (%S different between SCfor fresh or thawed sam

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; (-) = negative; A/E = adverse event; EJ = ejaculation; SpC = sperm count; SpMot = sperm mo

morphology; VS = vibratory stimulation; ES = electrical stimulation; IVF = in vitro fertilization; FSH = follicle-stimulating hormone; LH = lu

antegrade; RG = retrograde; mln = millions; NOS = Newcastle Ottawa Scale 
Appendix E. Evidence Tables (continued)

Evidence Table 3: Evidence from conference proceedings of fertility rates in patients with SCI. 

E-68

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/Follow

Elliott, 

2000, 

ND 

(Ref ID 

3013) 

• Enrolled/ evaluated: 

57/57 

• % males: 50% of 

couples 

• Race/ethnicity: NR • Age: NR • Level of Injury: above 

T10 

• ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Dropouts: NR • Lost in follow-up: NR • N of sites: 1 • Funding: NR

• Study Design: Abstract from 

conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: NA 

• Pharmacologic: NR 

• Device: Vibrator (n=26) 

• Amplitude: NR• Frequency: NR• Mode/Admin. Route: NR • Other Device (n=29): 

Electrostimulator

• Type: NR • Manufacturer: NR • Surgical: NR 

• Procedure: NR 

• Behavioral: NR 

• Laboratory techniques (n=26; 

VS grp):

• Donor sperm insemination: NR • Sperm preparation: NR • Intrauterine insemination: in 

20% with/ without medication

• IVF: in 50% of VS cases • Intracytoplasmic sperm 

injection: in 30% of VS cases 

• Embryo cryopreservation: NR• Sperm cryopreservation: NR 

• Outcomes: 

• Pregnancy rates: 

18/26 (69.2%) in Vgrp; 34% in ES gr

• Miscarriage/ectop

NR 

• Live Births: 17/26 

VS grp; 11/29(24%in ES grp 

• Singletons: NR• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houcontrol(s); grp = group; pbo = placebo; μg = microgram; mg = milligrams; tx = treatment; hx = history; ∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; A/E = adverse event; SpC = sperm 

motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; mln = millions; AG = antegrade; RG = retrog
Appendix E. Evidence Tables (continued)

Evidence Table 3: Evidence from conference proceedings of fertility rates in patients with SCI (cont’d). 

E-69

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility

Criteria/Quality Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

LoecherErnst, 

1998, 

Germany

(Ref ID 

3020) 

• Enrolled/ evaluated: 

n=229/127 couples evaluated for conception

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Drop-outs: NR • Lost in follow-up: NR • N of sites: NR • Funding: NR

• Study Design: Abstract from 

conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Criteria Eligibility:

• Inclusion: NR • Exclusion: NR • Quality Assessment: NA

• Pharmacologic: NR 

• Device: Vibrator 

• Amplitude: NR• Frequency: NR• Mode/Admin. Route: NR • Other Device: Electrostimulator

• Type: NR • Manufacturer: NR • Surgical: NR 

• Procedure: NR 

• Behavioral: NR 

• Laboratory techniques:

• Donor sperm insemination: NR • Sperm preparation: NR • Intrauterine insemination+ VS at 

home: in 28 couples 

• IVF: 8 couples• Implantation of alloplastic 

spermatocele: 27 cases 

• Embryo cryopreservation: NR• Sperm cryopreservation: NR 

• Outcomes: 

• Measures of Fertility

Rates: NR 

• Seminal Parameters: 

reduced motility & divergence in sperm count in all ejaculatesquality not improved with repeatedstimulation; ES resultein lower quality semen 

• Ejaculation Rates: 

semen was retrieved i168/229 (73%);161/168(96%) with VS7/168(4%) with ES 

• Pregnancy rates: 52/1

(41%); (82/127 includi2nd pregnancies & twins) 

• Miscarriage/ectopic: 

19/82 (1twin) 

• Induced abortion: NR • Live Births: rate NR; 6

healthy childrenincluding 2nd babies 

• Singletons: 63 includin

2nd babies 

• Multiples: 5 sets of tw• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houcontrol(s); grp = group; pbo = placebo; μg = microgram; mg = milligrams; tx = treatment; hx = history; ∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; A/E = adverse event; SpC = sperm 

motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; mln = millions; AG = antegrade; RG = retrog
Appendix E. Evidence Tables (continued)

Evidence Table 3: Evidence from conference proceedings of fertility rates in patients with SCI (cont’d). 

E-70

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility Criteria/ 

Quality Assessment 

Intervention 

(e.g., Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/Follow-u

Seager, 

2000, 

ND

(Ref ID 

3012) 

• Enrolled/ evaluated: 

total n=565:n=460 SCI; n=105 other& 2nd

grp of 16 couples withSCI prior to pubertyevaluated for conception/ n=565 & 16 couples 

• % males: 100%• Race/ethnicity: NR • Age 32.1 (16-61) y• Level of Injury: NR • ASIA Level: ANR • Duration since injury: 

NR 

• Previous fertility: NR • Dropouts: NR • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: Abstract from 

conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: NA 

•

• Device: Seager

Electrostimulatror (n=460 SCI; n=105 other) 

• Amplitude: 200 mamp; range 

100-700 mamp/ 9 V 

• Frequency: NR• Mode/Admin. Route: NR • Other Device: NR 

• Surgical: NR 

• Procedure: NR 

• Behavioral: NR 

• Laboratory techniques: NR

•

• Measures of Fertility

Rates: 2nd grp of SC15/16 had sperm in ejaculate & fertilitypotential similar to SCpost-puberty

• Seminal Parameters: • Ejaculation Rates: 

success rate expectaby authors, 100% 

• Follow-up: NR

Pharmacologic: NR Outcomes: 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houcontrol(s); grp = group; pbo = placebo; μg = microgram; mg = milligrams; tx = treatment; hx = history; ∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; A/E = adverse event; SpC = sperm 

motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; mln = millions; AG = antegrade; RG = retrog
Appendix E. Evidence Tables (continued)

E-71

Evidence Table 3: Evidence from conference proceedings of fertility rates in patients with SCI (cont’d). 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Eligibility Criteria/ 

Quality Assessment 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/ Follow-up

Park, 

1999, 

Korea 

(Ref ID 

3002) 

• Enrolled/ evaluated: 

n=17/ n=17 

• % males: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: above 

& below T10 

• ASIA Level: NR • Duration since injury: 

NR 

• Previous fertility: NR • Dropouts: NR • Lost in follow-up: NR • N of sites:1 • Funding: NR

• Study Design: Abstract from 

conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: NA 

• Pharmacologic: NR 

• Device: Ferticare Vibrator 

(n=17) 

• Amplitude: NR• Frequency: NR 

• Mode/Admin. Route: 3 

times/ wk

• Other Device (n = 17): 

Electrostimulator 

• Type: Seager • Manufacturer: NR • Mode/Admin. Route: 3 

times/ wk

• Surgical: NR 

• Procedure: NR 

• Behavioral: NR 

• Laboratory techniques: NR

• Outcomes: 

• Measures of Fertility

Rates: rate of adequate sperm quality in lesions above T10 81.8% in vs. 66.7% in ES; in lesions T10 & below, 82.6% in E(rate for VS is NR) 

• Seminal Parameters: 

Sperm quality not improved with repeated EJ. 

• Ejaculation Rates: 100% 

in ES, in lesions above T10 91.7%, in lesions at below T10, NR 

• Pregnancy rates: NR

• Follow-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houcontrol(s); grp = group; pbo = placebo; μg = microgram; mg = milligrams; tx = treatment; hx = history; ∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; A/E = adverse event; EJ = ejaculati

SpMot = sperm motility; SpMor = sperm morphology; VS = vibratory stimulation; ES = electrical stimulation; mln = millions; AG = antegra

vitro fertilization 
Appendix 

E. Evi

dence Tables (continued)

E-72

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

A

d

v

erse 

Compl

Derry, 

1998, UK 

(Ref ID 

58) 

• Enrolled/ 

evaluated: n=27/n=27 

• % males: 100%• Race/ethnicity:

NR 

• Age: NR (21-49) y• Level of Injury: 

T6-L5 

• ASIA Level: 

Sildenafil grp, A n=8; B n=2; C n=2; D n=1; pbo grp, A n=6; B n=1; C n=3; D n=4 

• Duration since 

injury: ≥6 mo 

• Drop-outs: n=2 • Lost in Follow-up: 

NR 

• N of sites: 3 • Funding: Pfizer

• Study Design: Part 

1:randomised, doubleblind, 2 -

way cross over 

design Part 2: randomized, double-blind, parallel-grp design 

• Duration: 28 d 

• Eligi

bility Criteria: 

• Inclusion: 1. documented

hx of SCI ≥6 mo, 2. female partner, 3. ED solelyattributable to SCI, 4. ability to achieve grade, reflexogenic erectile response, 5. pts must stop self intracavernous injections 1 

wk pre 

screening 

• Exclusion: T5 level or 

above genital anatomic deformities causing penile ED hypotension <80/50, stroke, subarahnoid haemorrhage, bleeding disorder, peptic ulcer disorder, nitrate or anticoagulant use, excessive alcohol use, clinical depression 

• Quality Assessment: 3/5 

Jadad scale

• Pharmacologic (n=27):

• Drug name: sildenafil 

• Dose: 50 mg • Duration: 28 d • Schedule: NR • Mode/Admin. Route max 

1 dose / d 

• De

vice: Vibrator (n

=27)

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR • Other De

vice: NR 

• Surgical: NR• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 

After 28 d of tx., 9/12 pts (75%) on sildenafil & 1/14 pts (7%) on pbo reported that tx improved erections (p=0.0043). 8/12 pts (67%) on sildenafil & 2/13 pts (15

%) on pbo 

wanted to continue tx(p=0.018) 

• Psychological: 

questions assessing satisfaction with sexlife demonstrated S df with pts receiving sildenafil > pbo(p=0.0122). 

• Sexual Satisfaction: S 

improvement in sexualsatisfaction reported by pts taking sildenafil (p=0.012) 

• A

dditional Outcomes: 

oral sildenafil (not > 1 x d) S improves qualityof erections & satisfaction with sexlife in men 

with SCI & 

ED bet

ween T6 & L5 

• Foll

o

w-up: NR 

• A/

E: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

minute; cm = centimeters; sec = seconds; mg = milligrams; μg = microgram; ctrl = control(s); grp = group; pbo = placebo; RCT = randomclinical trial; tx = treatment; hx = history; ∆ = change; S = significant; df(s) = difference(s); NS = nonsignificant; pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; three times daily; b.i.d = t

wo times daily; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-73

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outco

mes/F

ollo

w-up

A

Giuliano,

1999, UK 

(Ref ID 

284) 

• Enrolled/ 

evaluated: n=178/ n=NR 

• % males: 100%• Race/ethnicity: NR • Age: NR (19-63) y• Level of Injury: NR • ASIA Level: NR • Duration since 

injury: 0.7-38 y 

• Drop-outs: 2/178 

active phase; 3/178 pbo phase; 

• Lost to follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

randomizeddouble-blind pbo ctrl crossover design 

• Duration: 20 

wk

• Eligi

bility

Criteria: 

• Inclusion: SCI 

men >18 

with 

ED (cause bySCI); SCI >6 mo 

• Exclusion: NR • Quality

Assessm

ent: 

2/5 Jadad scale

• Pharmacolo

gic (n

=178): 

• Drug name: sildenafil/ pbo • Dose: 25, 50 or 100 mg of 

drug/ pbo 

• Duration: 6 

wk with 2 

wk

wash out period 

• Schedule: approximately 1 

hr pre-sex activity

• Mode/Admin. Route: oral• De

vice: NR 

• Other De

vice: NR 

• Surgical: NR • Beha

vioral: NR 

• Outcomes: • IIEF: 83% (168/178) 

reported improved erections with sildenafil vs. 12% on pbo (p<0.0001) 

• GEQ2: ability to achieve 

intercourse improved in (132/166) 80% on sildenafil vs. 10% on pbo 

• Ability to achieve 

(p<0.0001)& maintain anerection for intercourse (p<0.0001); satisfaction with sexual intercourse(p<0.0001); frequency of ejaculation (p=0.0012; satisfaction with sexual relationship with partner (p<0.0001) all i

mproved

vs. pbo 

Foll

o

w-up: NR 

• A/

E:

• System

moderin 5/17dyspeptransiein 2%; reporte

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = two times daily; EIIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-74

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

A

d

C

Hultling, 

1999, 

S

weden 

(Ref ID 

285) 

• Enrolled/ evaluated: 

n=329/ n=178 

• % males: 100%• Race/ethnicity: NR • Age : NR (19-81) y• Level of Injury: C5-L1 

• ASIA Level: A-D, no 

designation 

• Duration since injury: 

NR 

• Drop-outs: n=0 • Lost in Follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design:

Part 1: RCT parallel design Part 2: RCT crossover design 

• Duration: 12 wk

study duration;washout - 4 

wk, 

done after first 6 wk

• Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 3/5 

Jadad scale

• Pharmacolo

gic 

(n=209): 

• Drug name: sildenafil • Dose: 25-100 mg on 

demand 

• Duration: 4 

wk

• Schedule: NR • Mode/Admin. Route: 

NR 

• De

vice: NR 

• Other De

vice : NR 

• Surgical: NR • Beha

vioral : NR

• Outco

mes: 

• Anatomic/Physiologic: 

erection: S improvement perceived by partners both in ability to achieve & to maintain erections 

when 

taking sildenafil vs. pbo. 

• Sexual Satisfaction: ability

to have intercourse assessed by S

CI pts 

considered improved by80% of those on sildenafilvs. pbo (effect of 10%). # of attempts at intercourse also much improved in both grp taking sildenafil

• Foll

o

w-up: 

• Length: NR • Duration: NR • Results: other results not 

covered above. sildenafil S improved erectile function inpts 

with ED of broadspectrum aetiology & those 

with ED due to SCI

• A/

E: NR 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

= history; ∆ = change; S = significant; df(s) = difference(s); NS = nonsignificant; pts = participants; n = n of participants; enrolled = n qual

analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = two times daily; Edysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-75

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Giuliano, 

1999, 

France

(Ref ID 

49/2049) 

• Enrolled/ 

evaluated: n=178/ n=170 

• % males: 100%• Race/ethnicity: N

R

• Age: 38 (NR) y • Level of Injury: NR 

• ASIA Level: A 

n=95 (53

%); B 

n=20; C n=12; D n=27; n=24 not categorized byASIA scale

• Duration since 

injury: pbo/sildenafil grp =10.3 (0.70-35) y; sildenafil/pbo grp11.7 (0.74-38) y 

• Drop-outs: n=8 • Lost in Follow-up: 

NR 

• N of sites: 19 • Funding: Pfizer

• Study Design: 

randomized double blind cross over 

• Duration: 20 wk: 4 

wk

run-in phase 

with no tx, 

two 6-

wk, double-blind, 

cross over tx separated by2-

wk washout, & 2-

wk f/u 

• Eligi

bility Criteria: 

• Inclusion: Men ≥18 y 

who 

sustained traumatic SCI at least 6 mo pre screening & with ED solely attributed to SCI. Stable relationship with female partner for 6 mo 

• Exclusion: 1. genital 

/anatomical deformities impeding ED; 2. hx of stroke/ MI or any S CVD within last 6 mo; 3. diabetes, 4.major haematological, renal, or hepatic abnormalities; 5. un

willingness to forego 

use of vacuum devices, intracavernous injection tx, or other tx for ED during study; 6. concomitant tx with nitrates 

• Quality Assessment: 3/5 

Jadad scale

• Pharmacolo

gic: 

• Drug name: sildenafil (n=89, 

n=85 completed tx)/ pbo (n=89, n=86 completed tx) 

• Dose: initial dose 50 mg of 

sildenafil up to 100 mg (4 tablets) or adjusted do

wnward to 1 tablet (25 

mg). After 6 

wk of tx, 4.6%, 

36.8%, & 58.6

% of pts 

receiving 25 mg, 50 mg & 100 mg of sildenafil, respectively/or matching pbo. 

• Duration: 38 d for each tx 

period 

• Schedule: 1 hr pre-sex. 

activity

• Mode/Admin. Route: • De

vice: NR

• Surgical: NR

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 111/143 S

with ED (78

%) reported improve

erections & preferred sildenafil tpbo. 127/168 (76%) including thwith no residual erectile function baseline, sho

wed improved 

erections. (+) drug effect in 132/(80%), pbo effect in 17/166 men (10%). In n= 25 pts 

with no resid

sexual function 16 (64%) had (+drug effect & all preferred sildento pbo (p<0.001). 

• Psychological: S drug effect in

erection (to achieve & maintain) reports of IIEF & pts log activity pbo (p<.005). Median proportion successful intercourse in pts log=55% 

with sildenafil vs. 0% in 

pbo (p<0.001) 

• Sexual Satisfaction: discontinua

rate of sildenafil 2% vs. 1% for pWhen data for all pts (includingthose 

with no residual erectile

function at baseline) analyzed, abaseline 127/168 (76

%) reporte

improved erections & preference for sildenafil vs. 7/168 (4%) 

with 

improved erections & preference for pbo (p<0.001). 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

(+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = t

wo times daily; ED = erectile 

Erectile Function; MI = myocardial infarction; CVD = cardiovascular disease 
Appendix 

E. Evi

dence Tables (continued)

E-76

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g., Pharmacologic/ 

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

Hultling, 

2000, 

Australia 

(Ref ID 

281) 

• Enrolled/ 

evaluated: n=178/ n=178 

•% males: 100%• Race/ethnicity:

NR 

•Age : 38 (19-63) 

y 

•Level of Injury: 

NR 

• ASIA Level: NR 

• Duration since 

injury: 11.7 (0.78) y

• Drop-outs: n=0 •Lost in Followup: NR •N of sites: 19 •Funding: Pfizer

•Study Design: RCT

cross-over design 

•Duration: run-in-period: 

2-4 

wk protocol: 6 

wk

for each pbo orsildenafil washout period: 2 

wk

•Eligi

bility Criteria: 

• Inclusion: ≥ 18 y,

traumatic SCI at least 6 mo pre screening, clinical diagnosis of ED caused only by SCI, & involvement in stable relationship with female for at least past 6 mo 

• Exclusion: laboratory

abnormalities, genital anatomical deformities, primary sexual disorder other than E

D, major 

psychiatric or psychological disorder, including majordepression, diabetes mellitus, hx of stroke or MI 

within last 6 mo 

•Quality Assessment:

2/5 Jadad scale

•Pharmacolo

gic 

(n=178): 

•Drug name: sildenafil • Dose: up

ward & 

do

wnward titration 

flexible dose of 25 mg 1 hr pre sexual activity(not > 1 x d), increasedto maximum of 100 mg, & adjusted 25 mg, respectively for each period. 

•Duration: pts 

randomized to 2 homogeneous grp receiving pbo & sildenafil in random order. Active, 2-4 

wk of 

run-in-period + 14 

wk

intervention length (6

wk+2wk+6wk); pbo, 

flexible dose matchingdose of sildenafil 

• Schedule • Mode/Admin. Route •De

vice: NR 

•Other De

vice: NR 

•Surgical: NR •Beha

vioral: NR 

•Outco

mes: 

• Anatomic/Physiologic: NR •Psychological: statistically S (p<0.05) 

improvements in favour of sildenafil at end of tx seen in 4/10 pts for general mental, physical, & psychosocial parameters. No S dfs in end-of-tx scores bet

ween sildenafil & 

pbo grps for PGW

B Index measure of selfctrl, MOS Family Survey, health vs. 1 y ago, 

or MOS SF-12 physical summary score. 

•Sexual Satisfaction: S increase in overall 

satisfaction 

with sex life (increase of 49% 

over baseline) & sexual relationship with partner (34% i

mprovement over baseline) 

with sildenafil > pbo (p<0.0001 for tx effect) 

•Pt logs/diaries/ Other: trend towards higher 

doses of pbo (4% at 25 mg to 81% at 100 mg) vs. sildenafil (5% at 25 mg to 59%at 100 mg). Erectile problem questionnaire: summary score improved S with sildenafil vs. pbo, percentage of 

∆ from baseline in

pbo (4.5%), vs. 22.5% in sildenafil (p<0.0001) 

•Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = two times daily; EIIEF = Index of Erectile Function; MI = myocardial infarction; PGW

B = psychological general 

well-being; MOS-SF = Medical Outcome Sh
Appendix 

E. Evi

dence Tables (continued)

E-77

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & Duration/Quality

Assessm

ent/ Eligi

bility Criteria

Intervention 

(e.g.,Pharmacologic/

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

Maytom, 

1999, UK

(Ref Id 

55) 

• Enrolled/ 

evaluated: n=27/ n=26 

•% males: 100%• Race/ethnicity:

NR 

•Age: NR (21-49) 

y 

•Level of Injury: 

T6-L5 

•ASIA Level: NR • Duration since 

injury: NR 

• Drop-outs: NR •Lost in Follow-up: 

NR 

•N of sites: 3 • Funding: Pfizer

•Study Design: RCT: cross-over design •Duration: study has 2 parts: 1. RCT, 

double blind t

woway cross over & 

assessed reflexogenic erectile response to PVS after single dose of sildenafil or pbo; 2. randomized, double-blind-pbo controlled parallel-grp evaluation of sildenafil in home setting 

•Eligi

bility Criteria: 

•Inclusion: 1. males aged 18-55 y; 2. 

documented hx of SCI (sustained at least 6 mo prior to screening); 3. female partner; 4. ED solely attributable to SCI; 5. ability to achieve at least grade 2 reflexogenic erectile response to PVS; 6. stable dose of drug therapy 1 mo pre screening 

•Exclusion: 1. pts 

with lesions at or above 

T5 level; 2. pts 

with genetic anatomical 

deformities causing ED; 3. vascular or endocrine causes of ED; 4. postural hypotension, BP <80/50 mmHg; 5. major haematological, renal, hepaticabnormalities; 6. diabetes; 7. hx of stroke, subarachnoid haemorrhage; 8. bleeding disorder; 9. active peptic ulceration; 10. use of nitrates or anticoagulant meds; 11. involvement with an experimental drugwithin last 3 mo; 12. alcohol use > than 28 units of alcohol per wk; 13. clinical depression

•Quality Assessment: 3/5 Jadad scale

•Pharmacolo

gic 

(n=27): 

•Drug name: sildenafil •Dose: 50 mg •Duration: 28 d • Schedule: • Mode/Admin. Route: 

1 hr pre sexualactivity (not to be taken > 1 x d),

•De

vice: NR 

•Other De

vice: NR 

•Surgical: NR •Beha

vioral: NR 

•Outco

mes: 

•Anatomic/Physiologic: Part 1

(65%) had erections of > than rigidity at penile base; Part 2, (75%) pts on sildenafil & 1/14 pts on pbo reported tx improverections. 

•Psychological: analysis of dia

sho

wed no df bet

ween grps 

w

respect to mean # of erectionenough for penetration (p=0.0of tx questionnaire indicated nbet

ween grps with respect to 

frequency of erections hard efor sexual intercourse (p=0.47that lasted as long as pt 

woul

liked (p=0.11)

•Sexual Satisfaction: pts in sild

grp more satisfied 

with their s

(p=0.001) 

•Foll

o

w-up: 

• Length: NR • Duration: RN •Results: 8/12 (67%) men on 

sildenafil & 2/13 (15%) on pbindicated that they wished to continue tx (p<0.02). Mean proportion of successful attemsexual intercourse 30% & 15%respectively (p=0.21).

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; mmHG = millimetres of mercury; ctrl = control(s); grp = group; pbo = plac

clinical trial; tx = treatment; hx = history; ∆ = change; S = significant; df(s) = difference(s); NS = nonsignificant; pts = participants; n = n of 

qualified; evaluated = n analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; berectile dysfunction; IIEF = Index of Erectile Function; PVS = penile vibratory stimulation 
Appendix 

E. Evi

dence Tables (continued)

E-78

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & Duration/Quality

Assessm

ent/Eligi

bility Criteria

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) 

Outcomes

up 

Potter, 

1998, 

Canada, 

US 

(Ref Id 

1097) 

• Enrolled/ 

evaluated: n=29/ n=28 

• % males: 97% • Race/ethnicity:

NR 

• Age: Park

wood: 

36.6 (26.9-46.4) y; VAMC hospital: 45.6 (37.5-53.7) y

• Level of Injury: 

n=18 C4-7; n=11 T3-12 

• ASIA Level: B 

n=6; C n=12; D n=11 

• Duration since 

injury: Park

wood 99.9

(64.0) mo; VAMC: 217.7(111.8) mo 

• Drop-outs: n=1 

SCI 

• Lost in Followup: NR 

• N of sites: 2 • Funding: NR 

• Study Design: RCT cross-over design 

• Duration: 4 

wk run-in-period; 2 

wk drug/pbo; 1 

wk

washout period

• Eligi

bility Criteria: 

• Inclusion: range 21-65 y, medical diagnosis of 

incomplete teraplegia/paraplegia made >2 y prior to study, neurological level of injury C4-T12, medically stable & able to breathe independently, & stable neurological deficits for >60 d prior to study. Also exhibition 5 or more of the following: paresis, sensory loss, pain, spasticity, bo

wel, & bladder of sexual 

dysfunction. If female, had to be post-menopausal or surgically sterile, or using an acceptable method of birth ctrl. 

• Exclusion: risk of epileptiform seizures, hx of CVD, 

cancer, diabetes, impaired hepatic or renal function, or S liver disease < 6 mo pre-study or total bilirubin > 2xupper limit of normal range; known allergy to pyridinecontaining medicine, infections, neurologic, degenerative or psychiatric disorders to impair completion of protocol or provide informed consent or any illness or abnormality that may jeopardize their safety or interfere 

with conduct of study. Pts 

who had 

received any investigational drug < 30 d prior to study,had hx of substance abuse, unable to discontinue excluded concomitant medications, tx 

with an

antispasticity compound & could not maintain stable daily dosage or had received any drug kno

wn to cause 

S major organ toxicity < 3 mo prior to study, or considered unlikely to complete study also excluded. Also, pregnancy/potential pregnancy, or lactation. 

• Quality Assessment: 3/5 Jadad scale 

• Pharmacolo

gic (n

=29): 

• Drug name: FampridineSR 

• Dose: 12.5 mg b.i.d. for 

wk 1 & increased to 17.5 mg b.i.d on 

wk 2. 

Washout period of 7 d, & pbo 

with matching dose & 

titration pattern for next 2 wk

• Duration: 5 wk• Schedule: NR • Mode/Admin. Route: 

random assignment to Fampridine-S

R or pbo 

during first period followedby washout period & cross over to receive opposite tx 

• De

vice: NR 

• Other De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR 

• Outco

me

• Psycholog

statisticallbenefits omeasures bo

wel, bla

sexual funfunctional independe

• Sexual Sa

no S effecsexual funresult of 4Some impin sexual defined by more freqmore sustpenile erereported ifollo

wing

Fampridin4 (15%) fopbo (p=0.

• Foll

o

w-up

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

(+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = t

wo times daily; ED = erectile 

Erectile Function; CVD = cardiovascular disease 
Appendix E. Evidence Tables (continued)

E-79

Evidence Table 4: RCT evidence of sildenafil & other remediation for the treatment of sexual dysfunction in individuals after SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ 

Eligibility Criteria 

Intervention (e.g., 

Pharmacologic/Device/ 

Behavioral/Surgical/other) Outcomes/Follow-up

Renganathan, 

1997, 

India

(Ref ID 

307) 

• Enrolled/ 

evaluated: n=28/ n=28 

• % males: 100%• Race/ethnicity:

NR 

• Age: NR (16-

60) y

• Level of Injury: 

NR 

• ASIA Level: NR • Duration since 

injury: > 3 mo post SCI 

• Drop-outs: n=0 • Lost in Followup: NR 

• N of sites: 1 • Funding: NR 

• Study Design: RCT

cross-over design 

• Duration: NR 

• Eligibility Criteria: 

• Inclusion: SCI with

ED 

• Exclusion: duration 

of lesion < 3 mo, age < 16 -> 60 y, active infection, hyposadias, impotence prior to injury

• Quality

Assessment: 0/5 Jadad scale

• Pharmacologic (n=28):

• Drug name: transdermal 

nitro-glycerine vs. intracavernous injection of papaverine 

• Dose: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: NR

• Device: NR 

• Other Device: NR 

• Surgical: NR 

• Behavioral: NR 

• Outcomes: 

• Anatomic/Physiologic: erectile

index compared between 2 grps with statistically S df (p=0.045) in favour of papaverine. Erection occurred in 5 m & subsided after 30-40 m in most pts with injection of paparvarineof 10 mg. Higher doses (20, 40, & 60 mg) maintained erection for longer duration. 

• Follow-up: 

• Length: NR • Duration: NR • Results: Mean value for erectile 

index in papaverine grp 164.5 & in nitro-glycerine grp 106.

• A/E

• Sys

paphea3. p

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houcentimeters; sec = seconds; mg = milligrams; μg = microgram; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); NS = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

(+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = two times daily; ED = erectile 

Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-80

E

vidence Table 4: RCT e

vidence of sildenafil & other remediation for the treatm

ent of sexual d

ysfunction in indi

viduals after 

SC

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Sipski, 

2000, US 

(Ref ID 

475) 

• Enrolled/ 

evaluated: n=19/ n=19 

• % males: 0% (all 

female) 

• Race/ethnicity:

NR 

• Age: NR (35-58) 

y 

• Level of Injury: 

14 women hadUMN & 5 had LMN injuries affecting sacral cord 

• ASIA Level: NR • Duration since 

injury: 131.47(15-457) mo 

• Drop-outs: n=0 • Lost in Followup: NR 

• N of sites: 1 • Funding: NIH 

• Study Design: 

RCT cross-over 

• Duration: 2 d 

• Eligi

bility Criteria: 

• Inclusion: 1. nonpregnant women 

bet

ween 7-14 d of 

last menses (pregnancy testdone) 

• Exclusion: NR • Quality

Assessm

ent: 2/5 

Jadad scale

• Pharmacolo

gic (n=19 ):

• Drug name: sildenafil • Dose: 50 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: NR • De

vice: NR 

• Other De

vice: NR 

• Surgical: NR 

• Behavioral (n

=19) 

• Type: video/visual 

stimulation 

• Duration: NR • Frequency: N

R

• Outco

mes: 

• Anatomic/Physiologic: • S 

∆s in VPA (p<.02) 

with 

increasing levels of sexual stimulation. Borderline S effect of drug tx (p<0.07) observed, 

with

markedly increased VPA on sildenafil vs. pbo in manual plus visual stimulation condition. Lesser increases observed invisual stimulation alone condition.

• Psychological: S increases in 

Subjective Arousal (SA) observed with both drug (p<0.01) & sexual stimulation conditions (p=0.001), & borderline S (p<0.07) effect of drug administration on VPA noted. Maximal responses occurred when sildenafil combined 

with

visual stimulation & manual stimulation. Cardiovascular data sho

wed modest increases in HR 

(+/- 5 BPM) an mild decreases in BP (+/- 4 mmHg) across all stimulation conditions, consistent with peripheral vasodilatorymechanism of drug 

• Foll

o

w-up: NR

• A/

E

• Sys

sildehea1/19 

2/19 pbo1/19 pelveffedura

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

(+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = t

wo times daily; ED = erectile 

of Erectile Function; UMN = upper motor neuron; LMN = lo

wer motor neuron; NIH = Nation Institute of Health; VPA = vaginal pulse a

mpl

minute; mmHG = millimeters of mercury
Appendix E. Evidence Tables (continued)

E-81

Evidence Table 5: Evidence from other study designs regarding sildenafil & other remediation for the treatment of sexual dysfuafter SCI 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ 

Eligibility Criteria 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioral/Surgical/other) Outcomes/Follow-up Adverse Event

Beretta, 

1986, 

Italy

(Ref ID 

402) 

• Enrolled/ 

evaluated: n=22/ n=NR 

• % males: 100%• Race/ethnicity: NR • Age: NR (18-52) y• Level of Injury: 

n=7 above T10-T11; n=10 thoracolumbar; n=5 sacral; n=9 complete; n=13 incomplete lesion 

• ASIA Level: NR • Duration since 

injury: ≥ 1 y 

• Dropouts: n=0 • Lost to follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligibility

Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessment:5/19 (+) reported 

• Pharmacologic (n=22): • Drug name: papaverine • Dose: 20-30 mg• Duration: NR • Schedule: NR• Mode/Admin. Route: 

injection into one of cavernous bodies 

• Device: NR 

• Other Device: NR • Surgical: NR• Behavioral: NR

• Outcomes: • Anatomic/Physiologic: 

20/22 obtainederection with complete rigidity, with mean duration of 4.1 hrs 

• Sexual Satisfaction: 

20/22 successful intercourse 

• Follow-up: • Length: 3 mo • Duration: NR • Results: 20/22 offered 

training in selfinjection; 10/20accepted self-injection & had coitus 1 x wk for > 3 mo

• A/E: 

• Systemic: long 

erection in 7/22(controlled by ininjection of ethilof corpus) 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

= control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = his= significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analy

times daily; b.i.d = two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-82

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (continued) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Events

Beretta, 

1993, 

Italy

(Ref ID 

339)

• Enrolled/ 

evaluated: n=15/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 29.4 (20-

38) y

• Level of Injury: 

n=9 T2-7; n=2 T12-L1; n=4 L1-L5 (n=12 Complete n=3 Incomplete) 

• ASIA Level: NR • Duration since 

injury: 1.3 (1-2) y 

• Dropouts: n=0 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: NR

• Study Design:

NCS 

• Duration: NR 

• Eligi

bility

Criteria: 

• Inclusion: Pts 

who achieved erectionsufficient for vaginal penetration after Prostaglandin E1 injection included

• Exclusion: NR • Quality

Assessm

ent:

8/19 (+) reported 

• Pharmacolo

gic (n

=

x): 

None

• Drug name: Prostaglandin 

E1 injection -2% Minoxidil solution 

• Dose: 1 ml of 2.5-10 

micrograms 1 ml 2% minoxidil solution (RegaineUpjohn) up to 60 ml of 2% minoxidil solution 

• Duration: NR • Schedule: NR 

• Mode/Admin. Route: 

(2ml/d) to try at home if complete or partial response to minoxidil achieved 

• De

vice: NR 

• Oth

er De

vice: 

• Surgical: NR• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: • n=9 (+) response: 4 

with

complete & 5 with partial response. n=6 no response, NR, NR, Complete response achieved only in paraplegics with dorsal lesion. No relationbet

ween level of lesion & 

results of minoxidil test 

• Psychological: NR • Sexual Satisfaction: NR • Pts logs/diaries: • Intervie

ws: 

• Foll

o

w-up: 

• Length: NR • Duration: NR • Results: 9 pts with complete or 

partial response continued to use minoxidil (2ml/d) at homefor 1 mo. Result of subjective evaluations based on questionnaires: 26.6%(4 of 9) obtained an erectile responseto minoxidil solution sufficient for vaginal penetration. All paraplegic with complete dorsal level who had obtaineda complete response during minoxidil test. 3 SCI men chose to use minoxidil vs. prostaglandin E1 injection. 

• A/

E:

• System

follo

win

applicatNo med

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

= control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = hisS = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n ana

three times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-83

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outco

mes/F

ollo

w-up

Bodner, 

1999, 

US 

(Ref ID 

293)

• Enrolled/ 

evaluated: n=15/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 47 (30-70) y• Level of Injury: 

quadriplegia 7;paraplegia 8 (>sacral reflex arc) 

• ASIA Level: NR • Duration since 

injury: 7 y 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: men 

with SCI at 

least 1 y after injurypreviously treated byintracavernous injection therapy for SD (Previous SD Treatments: n=15: either papaverine or incombination with phentolamine for intracavernous injection therapy) 

• Exclusion: NR • Quality Assessment: 8/19 

(+) reported 

• Pharmacolo

gical (n

=15): 

• Drug name: intraurethral 

prostaglandin E1 – MUSE 

• Dose: 125 miug with

escalation to 1000 miug 

• Duration: NR • Schedule: NR• Mode/Admin. Route: 

injection 

• De

vice: NR 

• Oth

er De

vice (n=12 ): 

• Type: constricting band on

penis 

with application of 

MUSE 

• Manufacturer: NR

• Surgical: NR• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: all pts 

required max dose of alprostadil (MUSE, 1000 μg); with intracavernosal injection (papaverine 

with or 

without 

phentolamine) 12/15 achievedgrade 1-3 erections, 3/15 achieved grade 4 erections, 15/15 achieved grade 5 erection

• Psychological: NR • Sexual Satisfaction: complete 

satisfaction n=0 

with quality of

erection using MUSE; n=3 

with

grade 4 erection after MUSE returned to use of intracavernous injection therapy. 

• Pt logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; miμg/μg = microgram; tx = treatment; hx = 

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; SD = sexual dysfunction; IIEF = Index of Erectile F
Appendix 

E. Evi

dence Tables (continued)

E-84

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outco

mes/F

ollo

w-up

Chancellor, 

1994, 

US 

(Ref ID 

335)

• Enrolled/ 

evaluated: n=18/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 29 (19-65) y• Level of Injury: 

C7-L3, n=15 thoracics 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: No E

D prior to 

SCI. Ability to achieve only poorly sustained reflex erection inadequate for intercourse, no hypertension, no previous use of antihypertensive meds & minoxidil orally or topicaly, no prior therapy for ED

• Exclusion: hx of

psychogenic i

mpotence, 

diabetes mellitus, thyroid, renal, hepatic or vascular disease, myocardial infarction or use of organic nitrates or nitrites 

• Quality Assessment:

8/19 (+) reported 

• Pharmacolo

gic (n

=18): 

• Drug name: 2

% minoxidil 

solution, intracorporeal papaverine injection 

• Dose: 10 mg intracorporeal 

papaverine 

• Duration: NR • Schedule: sequential order 

for each pts, 

with 15 m 

interval (or to full detumscence) 

• Mode/Admin. Route: 

injection of papavarine/ 1 ml of 2% minoxidil solutionsprayed onto glans penis 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical (n=18) • Type: VCD • Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 

Topical

application of minoxidil caused minimun response subjectively & objectively. % of 

∆ in rigidity: 

minoxidil tx:0-15%, VCD therapy:30-80%(median rigidity of 57%), intercorporeal papaverine injection: 30-100%(median 77%). Erectile rigidity S less (p<0.05)with topical minoxidil than witheither VCD or papaverine. No S df in rigidity bet

ween VCD therapy & 

papaverine (p=0.34) 

• Psychological: NR • Sexual Satisfaction: Topical 

application of minoxidil caused minimum response subjectively & objectively.% of 

∆ in rigidity: 

minoxidil tx:0-15%, VCD therapy:30-80%(median rigidity of 57%), intercorporeal papaverine injection: 30-100%(median 77%). Erectile rigidity S less (p<0.05)with topical minoxidil than witheither VCD or papaverine. No S df in rigidity bet

ween VCD therapy & 

papaverine (p=0.34) 

• Pts logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; VCD = vacu
Appendix 

E. Evi

dence Tables (continued)

E-85

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up A

d

v

erse 

E

Chapelle, 

1988, 

France 

(Ref ID 

1318)

• Enrolled/ 

evaluated: n=135/ n=NR 

• % Males: 

100% 

• Race/ethnicity

: NR 

• Age: NR (18-

47) y

• Level of Injury: 

T12-L2 

• ASIA Level: 

NR 

• Duration since 

injury: NR (0.5-33) y

• Dropouts: n=0 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: urological 

or medical causes of testicular damage (orchiepididy

mis, 

destructive functional tx of lo

wer urinary

tract, cryptorchidy & systemic lupus 

• Quality Assessment:

8/19 (+) reported 

• Pharmacolo

gical 

(n=135): 

• Drug name: 

physostigimine+ N- \buthyigyoscine

• Dose: 0.2 mg/ 40mg • Duration: NR • Schedule: NR • Mode/Admin. Route: 

intervention consisted of 3 physostigimine tests. Each test = 0.2mgs s/c (in association 

with 40 mgs 

N-buthyihyoscine) follo

wed by masturbation 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR • Beha

vioral (n=135) 

• type: masturbation post 

medication tx

• Duration/Frequency: NR 

• Outco

mes: 

• Anatomic/Physiologic: 

relation bet

ween testicular 

vol & SCI in n=86 pts (45 from EJ grp & 41 from ANEJ grp): Mean testicular vol did not differ S from that of ctrl. 

Testicular vol. 

slightly lower in ANEJ grp than EJ grp (t= 1.8, not S) Mean testicular vol did not differ S from that of SCI pts & ctrl. 

The relation between 

testicular vol & SCI in n=86 pts (45 from EJ grp & 41 from ANEJ grp): Mean testicular vol did not differ S from that of Control. Testicular vol. slightly lower in ANEJ grp than EJ grp (t=1.8, not S) Mean testicular vol did not differ S from that of SCI pts & ctrl

• Psychological: NR • Sexual Satisfaction: NR • Pt logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up: NR

• A/

E:

• Systemic

Dysreflex

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-86

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outcomes/ Follo

w-up

Costa, 

1992, 

France 

(Ref ID 

353)

• Enrolled/ evaluated: 

n=26/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 31.2 (24-39) y• Level of Injury: all 

complete lesions 

with

paraplegic - upper levels of spinal cord 

• ASIA Level: NR • Duration since injury: 

NR 

• Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NR

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: screening 

included haematology, urinalysis, liver function test (alkaline phosphatase, total bilirubin & lacticdeshydrogenase), hx & physical exam. All had normal height (178.5 +/-5.7cm) & 

weight (75.8 

+/-12.5kg). No hx or allergies, no drugs of any kind in 2 

wk pre-tx. 

No drugs of enzyme inducers or inhibitors in 3 mo pre study. 

• Exclusion: NR • Quality Assessment:

12/19 (+) reported

• Pharmacolo

gic (n

=26): 

• Drug name: moxisylyte, 

dissolved in 2 ml physiological saline 

• Dose: 30 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: 

Intracavernous injection; blood sampling before dosing (20ml) & at 0.08, 0.17, 0.33, 0.55, 1, 1.5, 2, 2.5, 3, 3.5, 4 & 8h post dosing (10 ml)

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 

successful erections (10-20 m) obtained in all pts. NS decrease of BP 

with admin of drug. NS df 

bet

ween screening lab tests 

performed pre & post tx. Metabolites found in plasma: Unconjugated DAM, glucuronide & sulpho derivates of DAM & MDAM. 

The eli

mination halflives are 0.89 +/-0.35 h for 

unconjugated DAM, 2.16 +/-0.85 h for conjugated VAM, & 5.32 +/3.23 h for conjugated MDAM. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; PB = blood 
Appendix 

E. Evi

dence Tables (continued)

E-87

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

A

d

Events/Co

Costa, 

1993, 

France 

(Ref ID 

344)

• Enrolled/ 

evaluated: n=12/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 34 (25-43) 

y 

• Level of Injury: 

n=1 C6-7 n=7 T3-T12 n=2 

T12-

L1 n=1 L1 All complete SCI 

• ASIA Level: NR • Duration since 

injury: 3-26 y

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1

• Funding: NR

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: Erectile 

impotence due to posttraumatic paraplegia 

• Exclusion: Peyronie's

disease, impotence related to another etiology than SCI, unbalanced bladder, bedsores, cardiac, renal, hepatic or ventilatory failure, systolic blood pressurebelow 10 cm Hg

• Quality Assessment:

8/19 (+) reported 

• Pharmacolo

gical (n

=12): 

• Drug name: moxisylyte • Dose: 20 mg • Duration: NR • Schedule: NR• Mode/Admin. Route: 4 

different vols: 0.4, 0.8, 1.2 & 2 ml. 7 d interval bet

ween

injections 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic

: NS df bet

ween 4 

injection vols. (0.4, 0.8,1.2 & 2 ml 20 mg moxisylyte) for mean max rigidity (2.8, 2.8, 2.3 & 2.3), abdominopenileangle (100,101,107 & 101 degrees), penile length increase (33,34,36 & 35 mm), penile circumference increase (31.5,32,31 & 29 mm), duration of erection(47,62.5,60,57 m). 

• Foll

o

w-up: NR

• A/

E: NR 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

hours; ctrl = control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatme

history; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualifie

= n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index 

Function 
Appendix 

E. Evi

dence Tables (continued)

E-88

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

E

Courtois, 

2001, 

Canada

(Ref ID 

1657)

• Enrolled/ evaluated: 

n=10/ n=NR 

• % Males: 100%• Race/ethnicity: n=2 

cervical, n=7 Thoracic, n=1 lumbar; all UMN lesions, n= 6 Incomplete, n=4 Complete 

• Age: 37.7 (25-52) y• Level of Injury: NR • ASIA Level: NR • Duration since 

injury: 7.1(1-23) y

• Dropouts: n=0 • Lost in follo

w-up: 

n=2 

• N of sites: 1

• Funding Source: 

FRSQ & Foundation Andre Senecal

• Study Design: NCS • Duration: 4 

wk

• Eligi

bility Criteria: 

• Inclusion: screening test 

included neurological examination to verifylesion level & perineal muscle activity. Sexual evaluation to confirm ED defined byplethsmographic recording, reflexresponses within normal latency (i.e. under 40 msec) 

• Exclusion: NR • Quality Assessment:

11/19 (+) reported

• Pharmacolo

gical: NR 

• De

vice: NR

• Oth

er De

vice (n =10):

• Type: Rigiscan Device 

(erectile measurements) 

• Manufacturer: NR • Surgical: NR 

• Beha

vioral (n=10):

• Type: Perineal training to 

investigate role of these muscles in erection. Technique combined 

with 

biofeedback & home exercises.

• Outco

mes: 

• Anatomic/Physiologic: SCI 

pts could achieve initial tumescence, revealed byan average increase inpenile circumference of 2.01 cm at beginning of training program. Follo

wing

4 wk of training, tumescence improved & reached an average of 3.22cm increase in penilecircumference. Post 4 

wk

of stopping tx average tumescence dropped to 2.66 cm. Penile rigiditymoved from 43% pre training to 59

% at end of 

training program & back to 47% following secession of tx. 

• Foll

o

w-up: NR

• 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; UMN = up

FRSQ = Fonds de la Recherche en Sante du Quebec 
Appendix 

E. Evi

dence Tables (continued)

E-89

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Earle, 

1992, 

Australia 

(Ref ID 

359)

• Enrolled/ evaluated: 

n=22/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 35.2 (20-45) y• Level of Injury: C5-7 

n=3, 

T5-12 n=8, L1 

n=2, S1 n=1 (n=3tetraplegic & rest are paraplegic); 11complete, 3 incomplete 

• ASIA Level: NR • Duration since 

injury: 27 (15-42) y

• Dropouts: n=5 • Lost in follo

w-up: 

NR 

•N of sites: 1

• Funding: NR 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 7/19 

(+) reported 

• Pharmacolo

gic (n

=19): 

• Drug name: Papaverin, 

/mixture of papaverine 40 mg & phentolamine, Prostaglandin E1 

• Dose: initial injection of 2-5 

mg; max 80 mg, mixture of papaverine 40 mg & phentolamine 0.5 mg, prostaglandin E1 1-2 microgram 

• Duration: NR • Schedule: range 1 x 

wk to 1-4 

x wk

• Mode/Admin. Route: mixture 

of papaverine 40 mg & phentolamine administered if pts failed to respond to papaverine alone 

• De

vice: NR 

• Oth

er De

vice: Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 

19/22 achieved full erection follo

wing 

injections.14 pts continued to use self injection, 8 usedpapaverine, 1 used combination of papaverine/ phentolamine & 3 used prostagl & in E1. 8 pts felt spontaneous erections improved with injections while 5 had unreliable spontaneous erections 

• Sexual Satisfaction: 

partner subjective responses to

wards 

injection tx: favorable in 9, 1 not 

willing, 1 

apprehensive & 1 partner glad not required every time 

• Foll

o

w-up: NR

• 

• • • 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-90

Evidence Table 5: Evidence from other study designs regarding sildenafil & other remediation for the treatment of sexual dysfuafter SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioral/Surgical/other) Outcomes/Follow-up

Gans, 

2001, 

US 

(Ref ID 

269)

• Enrolled/ 

evaluated: n=17/n=NR 

• % Males: 

100% 

• Race/ethnicity:

NR 

• Age: 40.3 (25-

58) y

• Level of Injury: 

cervical 4; thoracic 12; lumbar 1 

• ASIA Level: 

NR 

• Duration since 

injury: 9.8 (3-21) y

• Dropouts: n=1 • Lost in followup: 10 • N of sites: 1 • Funding: NR

• Study Design: NCS • Duration: Feb.- Sept. 

1998 

• Eligibility Criteria: • Inclusion: hx of

organic ED, SCI, & a consistent sexual partner 

• Exclusion: 

unwillingness to participate in f/u appointments, use of organic nitrates or nitric oxide donor compounds, dependency onalcohol or drugs, or major, uncontrolled medical illness,previous hx of ischemic events (e.g., myocardial infarction or stroke), or abnormal baseline testosterone 

• Quality

Assessment: 16/19 (+) reported 

• Pharmacologic (n=17): • Drug name: sildenafil • Dose: starting dose 25 mg 

with increase of dose in 25 mg increments; mean 

dose 73.4+/-33.5 mg 

• Duration: NR • Schedule: NR • Mode/Admin. Route: oral

(no ctrl wash-out period pre to tx) 

• Device: NR • Surgical: NR • Behavioral: NR

• Outcomes: • Anatomic/Physiologic: mean duration of

erection increased to 10 m post-tx. ScorIIEF questionnaire (all p<0.05): mean scconfidence that one could get & keep ereincreased 1.6-3.8; mean score of frequeerections hard enough for penetration increased from 1.1-3.8; mean scores of frequency of ability to maintain erection penetration of partner increased 1.3-4.1; duration of erection increased from 8.4-1difficulty maintaining erection to completintercourse improved 1.4-4.3.

• Sexual Satisfaction: mean scores freque

satisfaction with attempted sexual intercincreased 1.3-4.1(p<0.05); mean scores satisfaction with therapy increased 1.8 wprevious therapy to 3.5 post sildenafil (p

• Follow-up: (n=6) • Length: NR • Duration: mean duration f/u 5.3 +/-2.2 m• Results: NS in erectile function between 

long-term f/u except for an improvement quality of erection. All 6 pts stated that thwould recommend sildenafil therapy to a with ED SCI, no S ∆ in frequency of succintercourse between f/u periods

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function
Appendix E. Evidence Tables (continued)

E-91

Evidence Table 5: Evidence from other study designs regarding sildenafil & other remediation for the treatment of sexual dysfuafter SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Behavioral/Surgical/other) Outcomes/Follow-up

Golji, 1979, 

US 

(Ref ID 

414)

• Enrolled/ 

evaluated: n=30/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: NR (25-60) 

y 

• Level of Injury: 

36% cervical, 4%lumbar; 68% complete, 32% incomplete 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=5 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS 

• Duration: 2 y

• Eligibility Criteria: 

• Inclusion: impotence 

due to SCI 

• Exclusion: NR• Quality Assessment:

7/19 (+) reported

• Pharmacologic (n=25): 

• Drug name: Gentamicin 

(non interventional) 

• Dose: NR • Duration: 1 d preoperatively

& 3-4 d postoperativelySchedule: NR 

• Mode/Admin. Route: orally; 

most underwent another wkof other antibiotic urinary antiseptic therapy. 

• Device: NR 

• Surgical (n=25):• Type: Small-Carrion penile 

prosthesis 

• Behavioral: NR

• Outcomes:

• Psychological: 18/20 wished 

they had penile implant sooner& 2 indicated marriages could have been saved if penile implant earlier.

• Sexual Satisfaction: 68% of pts 

with choice of oral sex preoperation & remaining 42% with no specific pattern in sexual satisfaction result of operation : (+) ∆ in sexual pleasure in 

intercourse & morale of pts & their partners 

• Follow-up: NR

• A

• 

c

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-92

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Green, 

1986, 

US 

(Ref ID 

192)

• Enrolled/ 

evaluated: n=40/ n=NR 

• % Males: 100% • Race/ethnicity: NR • Age: 33 (21-60) y• Level of Injury: NR • ASIA Level: A 

n=31; B-D n=9

• Duration since 

injury: > 0.75 –1 y

• Dropouts: n=4 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS 

• Duration: 1981-1986 

• Eligi

bility Criteria: 

• Inclusion: SCI pts 

suitable for penile prosthesis no less than 9-12 m post injury with: 1. stable bladder programs; 2. recent urologic X-ray evaluation; 3. sterile urine at time of implantation; 4. free of open skin lesions 

• Exclusion: NR• Quality Assessment:

7/19 (+) reported 

• Pharmacolo

gical: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical (n=36): 

• Type: penile implants: 1. 

semi-rigid penile implants; 2. inflatable penile implants

• Beha

vioral: NR

• Outco

mes:

• Sexual Satisfaction: 86% 

(31/36) intercourse regularly & pleased 

with their decision for 

implants; partners confirmed satisfaction as 

well; 11% 

(4/36) dissatisfied: all had semi-rigid implants & stated rods not rigid enough to sustain vaginal penetration; 1 wife not satisfied; 1 pt died but wife stated they had regular intercourse. 

• Foll

o

w-up: 

• Result: 8.3% (3/36) pts had 

extruded rods, all happened >2 y post implantation; 1 pt had paraphimosis requiring circumcision; 1 pt 

with an

inflatable prosthesis had minor erosion through fossa navicularis that spontaneouslyhealed

• A/

• Lo

po

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-93

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outco

mes/F

ollo

w-up

Gross, 

1996, 

German

y

(Ref ID 

85)

• Enrolled/ 

evaluated: n=209/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 39.9 (16-72) 

y 

• Level of Injury: 

77% paraplegic, 23% tetraplegic 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=37 • Lost in follo

w-up: 

n=17 

• N of sites: 1 • Funding: NR

• Study Design: NCS 

(Retrospective study)

• Duration: 1980-1992 • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 5/19 

(+) reported 

• Pharmacolo

gical: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical (n=209): 

• Type: semi-rigid (Jonas) 

prosthesis (in 49 pts 

with

ED, 113 pts 

with penile 

retraction & 47 

with both); 

prosthesis implanted under strict aseptic conditions with antibiotic prophylaxis 3 d pre & 5 d post surgery.

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: n=179 evaluab

234 operations in 209 pts 

with revisio

due to perforation, infection ormalfunction. 143/209 initially received semi-rigid, 59 semi-flexible & 7 flexibpenile prosthesis. After revisions, 127 still had a semi-rigid, 74 a semi-flexib& 8 a flexible prosthesis. 

• Sexual Satisfaction: Of pts treated fo

penile retraction, 92% satisfied 

with t

sexual life, & of those treated for ED, 83% satisfied. 

• Foll

o

w-up: n=165 

• Duration: mean of 5 y since i

mplanta

(range 0.6-11.4), 

• Results: 126/165 used penile

prostheses for external condomdrainage, 116(92%) succeeded; ED main indicator for penile prostheses in=83 (11 tetra & 72 para). 70/83(84%reported satisfactory sexual intercourpost-tx. Reasons for not using prostheses 

were: unsatisfactory surg

result in 5 pts, lack of stability in 2 ptssubcoronal ventral deviation in 3 pts, lack of interest in rest.

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = cha

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

(+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function
Appendix 

E. Evi

dence Tables (continued)

E-94

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

E

Heller, 

Israel, 1992 

(Ref ID 

149)

• Enrolled/ 

evaluated: n=30 (neurologicalimpotence)/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: NR 

• Level of Injury: 

NR 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=13 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NIDRR; 

US Dept. of Education; USIEF 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 8/19 

(+) reported 

• Pharmacolo

gical: NR 

• De

vice: NR 

• Other De

vice (n=30): 

• Type: vacuum 

tumescence 

• Manufacturer: 2 different 

VT

C

T devices: 1. Eracaid 

system, Osborn Medical Systems, Augusta, Georgia, USA; 2. Ved brand vacuum system, Mission Pharmaceuticals 

• Surgical: NR • Beha

vioral: NR

• Outco

mes: 

• Psychological: questionnaires 

used but scales not given 

• Sexual Satisfaction: 83% of 17

pts reported very satisfied 

with

sexual relationship after using VT

C

T; 100% of their partners 

reported very satisfied 

with

present sexual relationship; thisenhancement in satisfaction attributed to following: pts felt that they had a greater ability to give pleasure to sexual partners resulting in increased desire to engage in sexual activity; partners felt enhancement secondary to engaging in a more "natural" sexual relationship 

• Foll

o

w-up: NR

• A• L

coauotep

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; NIDRR = 

T

Disability &Rehabilitation Research; USIEF = US Israel Educational Foundation 
Appendix E. Evidence Tables (continued)

E-95

Evidence Table 5: Evidence from other study designs regarding sildenafil & other remediation for the treatment of sexual dysfuafter SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Behavioral/Surgical/other) Outcomes/Follow-up

Eve

Hirsch, 

1994, 

US 

(Ref ID 

326)

• Enrolled/ evaluated: 

n=27: SCI n=14; MS n=7; discogenic disease n=6/NR

• % Males: 100%• Race/ethnicity: NR • Age: 31.5 (22-39) y• Level of Injury: NR • ASIA Level: NR • Duration since 

injury: 8 y 

• Dropouts: n=15 (8 

SCI; 4 MS; 3 discogenic disease) 

• Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: NR • Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: 6/19 (+) reported 

• Pharmacological (n=27): • Drug name: intracavernous 

prostaglandin E1 - PGE-1 

• Dose: 1 pts 2.5 miμg & 

increased 2.5 miμg increments to mean maintenance dose of 6.2 miμg 

• Duration: NR • Schedule: NR • Mode/Admin. Route: NR • Device: NR • Other Device: NR • Surgical: NR • Behavioral: NR

• Outcomes: • Sexual Satisfaction: all pts 

completing protocol reported excellent penile rigidity & duration of erection on standardized home assessment questionnaires; no objective data available from article 

• Follow-up: • Duration: quarterly f/u visits 

up to 28 mo 

• Results: NR

• A/

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; miμg/μg = microgram; tx = treatment; hx = 

S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n ana

times daily; b.i.d = two times daily; (+) = positive; A/E = adverse event; MS = multiple sclerosis; ED = erectile dysfunction; IIEF = Index o
Appendix 

E. Evi

dence Tables (continued)

E-96

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Eve

Iwatsub

o,

1986, 

Japan

(Ref ID 

404) 

• Enrolled/ 

evaluated: n=37/n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 42 (21-63) y• Level of Injury: 10 

tetraplegic 23 paraplegic 4 walking with cauda equine 

• ASIA Level: NR • Duration since 

injury: mean 5 y 

• Dropouts: n=2 • Lost in follo

w-up: 

n=2 implant removed due to infection 

• N of sites: 1 • Funding: NR 

• Study Design: NCS • Duration: 5 y• Eligi

bility Criteria: 

• Inclusion: all SCI 

with 

urinary incontinence or impotence 

• Exclusion: NR • Quality

Assessm

ent: 5/19 

(+) reported 

• Pharmacolo

gical: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical (n=37): • Type: Shirai-type Penile 

Implant 

• Beha

vioral: NR

• Outco

mes:

• Sexual Satisfaction: 15 

pts (41%) reported improved marital life. 18 pts (48%) reported no 

benefit & 4 pts (11%) reported dissatisfaction. 

• Pt logs/diaries:

questionnaire surveyresult in 37 pts: 32 pts (86%) reportedsatisfaction with regards to better condom fitting & easier intermittent catheterisation, 5 pts (14%) dissatisfied/ discontinued. 

• Foll

o

w-up: NR

• A/

E:

• Syste

T12 cremoold Cmade 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-97

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Ja

w

orski, 

1992, 

US 

(Ref ID 

150)

• Enrolled/ 

evaluated: n=80/n=56/ SCI n=30; DBTn=26 

• % Males: 

100% 

• Race/ethnicity:

NR 

• Age: SCI 37.2 

(NR) y; DBT;51.4 (NR) y 

• Level of Injury: 

L-3 (10

%) T-20 

(67%) C-7 (23%), 63% motor & sensory complete 

• ASIA Level: 

NR 

• Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: 

NIDRR; US Dept. of Education 

• Study Design: Casecontrol Study • Duration: NR • Eligi

bility Criteria: 

• Inclusion: All pts 

screened for testosterone & prolactin levels, general physical exam & urinanalysis 

• Exclusion: NR • Quality

Assessm

ent: 3 * 

(NOS) 

• Pharmacolo

gical: 

• Drug name: 

Papavarine/phentolamine injection & penile prosthesis implant 

• Dose: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: NR • De

vice: NR 

• Other De

vice (n=56): 

• Type: snap gauge 

nocturnal peniletumescence monitoring 

• Manufacturer • Surgical: NR • Beha

vioral: NR

• Outco

mes:

• Sexual Satisfaction: vs. a normative 

sample both D

B

T & SCI males found 

to have better body image postimplant/injection. Also engaged in more sexual activities. 

• Pt logs/diaries: SCI men scored higher 

on sexual infor

mation & attitudes vs. 

DBT men; DBT men scored slightlyhigher on overall adjustment in relationship than SCI men (p < 0.07) 

• Measures of sexual satisfaction 

(sexual activities, frequency & 2 measures of satisfaction): pre-tx (implant/injection) S df bet

ween SCI >

DTB (p = 0.08); SCI more satisfied overall in sexual encounters (frequency, variety, duration, interest, communication) vs. DB

T; S time effect 

for all outcome measures, 

with S 

improvement for SCI & DBT males "on all measures" from pre to postprocedure (p = 0.0001). 

• Foll

o

w-up: NR

SCI = spinal cord injury; DBT = diabetics; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

hours; ctrl = control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatme

change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluatethree times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function

Institute on Disability &

Rehabilitation Research 
Appendix 

E. Evi

dence Tables (continued)

E-98

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Even

Kapoor, 

1993, 

India

(Ref ID 

341)

• Enrolled/ evaluated: 

n=101/n=

N

R

• % Males: 100%• Race/ethnicity: NR • Age: NR (20-51) y• Level of Injury: C4-

L4; n=9 complete, & n=27 incomplete tetraplegic; n=23 complete & n=42 incomplete paraplegic 

• ASIA Level: NR • Duration since 

injury: all>1 y 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• n of sites: 1

• Funding: NR

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: baseline 

tests (urine, hemoglobin, liver function tests & ECG) 

• Exclusion: NR • Quality Assessment:

10/19 (+) reported 

• Pharmacolo

gic (n

=109): 

• Drug name: papaverine • Dose: starting at 7.5 mg & 

increased according to status of erection 

• Duration: NR • Schedule: 2-3 x 

wk

• Mode/Admin. Route: 

intracavernous injection to posterolateral aspecto of penis at base 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

Outco

mes: 

• Anatomic/Physiologic: 

Dose-erection relation: all pts in younger age grp (up to 30 y) required 7.5-15 mg of papaverine. Older age grps required a higher dosage. 78 pts had good erection 

within 

10 m duration & 20 over 22 m. Duration of erection less than 1 h in 35, 1-2 h in 29, 2-4 h in 31 & more than 4 h in 3 pts. Lag period of erection onset 10 m in 78 pts, 20 m in 13 pts, & 30 m in 7 pts. 

• Sexual Satisfaction: 98 

pts achieved good erections & enjoyed coitus 

with their spouse 

Foll

o

w-up: 

• Length: NR • Duration: monthly

intervals 

• Results: NR 

• A/

E:

• System

haemaCaverafter p36 moerectiowith 1 caverndopamsystemcase d

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-99

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Kim, 

1995, 

US 

(Ref ID 

318)

• Enrolled/ evaluated: 

n=10: SCI n=9; mild arterial insufficiency n=1 

• % Males: 100%• Race/ethnicity: NR • Age: 33 (19-50) y• Level of Injury: n=4 

cervical; n=5 thoracic 

• ASIA Level: NR • Duration since injury: 

NR 

• Dropouts: n=1 • Lost in follow-up: NR • N of sites: 1 • Funding: Pharmedic 

Company

• Study Design: NCS • Duration: 5 d 

(interventions & assessments done ond 1, 3 & 5) 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: if hormonal 

or yohimbine therapyused within 6 m 

• Quality Assessment:

10/19 (+) reported

• Pharmacolo

gic (n

=10): 

• Drug name: 0.04% 

prostaglandin E1 topical gel 

• Dose: NR • Duration: 1h • Schedule: d 3• Mode/Admin. Route: 

medication applied to penis, scrotum &perineum 

• De

vice: NR 

• Other De

vice (n=10): 

• Type: color flow Doppler 

ultrasound, & L10-5 linear array transducer 

• Application: 10 m post –tx, to 

measure velocity & angle. 

• Surgical: NR • Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: mean

cavernous artery diameter (cm): pre-application 0.09 +/-0.02 & post-application 0.11 +/0.04; (p<0.05) mean peak flo

w

velocity (cm/sec): preapplication 15.4 +/-6.4 & postapplication 22.8 +/-7.3 (p<0.05); clinical erection (grade 4 & 5) occurred in 2 pts who did not have erections with pbo gel; mean diastolic B

P

variations (mm Hg): preapplication 78, post-application 83 (p<0.0001); mean H

R

variation (beats/m): preapplication 59 & postapplication 64 (p<0.01); NS 

∆’s 

in systolic & diastolic BP. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function ; mm HG = 

HR = heart rate; BP = blood pressure
Appendix 

E. Evi

dence Tables (continued)

E-100

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Kim, 

1995, 

US 

(Ref ID 

322) 

• Enrolled/ evaluated: 

n=20: n=13 SCI; n=7 other/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 40 (19-73) y• Level of Injury: n=8 

cervical; n=5 thoracic 

• ASIA Level: NR • Duration since injury: 

5.9 (0.6-27) y) 

• Dropouts: n=3 • Lost in follow-up: NR • N of sites: 1 • Funding: Pharmedic 

Company 

• Study Design: nonRCT• Duration: each pts 

evaluated on 5separate d for a 13-d period 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: pts 

excluded if hormonal therapy used 

within 6 

mo 

• Quality Assessment:

NA 

• Pharmacolo

gic (n

=

x): 

• Drug name: 5.5%, 7%, 

15%, & 20% topical papaverin gel; color flo

w

Doppler ultrasound 

with a 

L10-5 linear arraytransducer 

• Dose: papaverin gel: mean

295 mg; range 133-500 mg

• Duration: NR • Schedule: NR • Mode/Admin. Route: NR • De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR • Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: SCI pts 

grp (n=12): mean cavernous artery diameter increased 36%from 0.11-0.15 cm (p<0.001); mean peak systolic flo

w

velocity increased 21% 13.8-17.5 cm/sec (p=0.06); after genital application of papaverinBP 

∆’s did not reach statistical 

S; mean HR decrease after application statistically S: from 68 beats/m to 63 beats/m at 30 m (p<0.0004); clinical erectionof grade 5 noted in 3/17 pts (18%) 

with both papaverin & 

placebo gel applications, but in papaverin grp duration of erection longer: 38.7 +/-18.7 m vs 8.0 +/-4.6 m. (NS) 

• Pt logs/diaries/ Other: mean 

serum papaverin levels after genitalia application (ng/ml): 10.5 at time 0, 9.9 +/-3.3 at 15 m, 13.8 +/-4.4 at 30 m, & 15.1 +/-4.8 at 60 m. 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clinical t

history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enrolled = n qualifie

(+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; b.i.d = t

wo times daily; ED = erectile 

Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-101

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device

/Beha

vioral/Surgical/other) Outco

mes/F

ollo

w-up

Komisaruk, 

1997, 

US 

(Ref ID 

 530)

• Enrolled/ evaluated: 

n=32: SCI n=16; ctrl n=16/ n=NR 

• % Males: 0%(all 

female) 

• Race/ethnicity: NR • Age: SCI 37.2 (25-55) 

y; ctrl 45.4 (35-56) y

• Level of Injury: SCI 

T10 &/or above n=6; SCI 

T10 & belo

w

n=10 

• ASIA Level: NR • Duration since injury: 

12.4 (2-27 y)

• Dropouts: n=1 SCI • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: Casecontrol Study • Duration: NR • Eligi

bility Criteria: 

• Inclusion: SCI: 

incomplete at least 1-ypost injury, no hx of autonomic dysreflexia, minimum age 21 y.Uterus & cervix intact in all pts 

• Exclusion: psychosis 

or severe depression, cystocele or hysterectomy

• Quality Assessment:

6 * (NOS) 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Other De

vice (n=32): 

• Type Pain threshold 

measurement: Frey & Passive stimulator 

• Surgical: NR • Beha

vioral (n=32) 

• Type: self stimulation of 

vaginal, cervical, sensate region in random order 

• Duration: 90 m total 

consisting of 12 m stimulation for each experimental condition preceded & followed byresting, non-sti

mulation rest 

period. 

• Frequency: 1 x/ 

experimental condition 

• Outco

mes: 

• Anatomic/Physiologic: Ctrl Gr

vaginal self stimulation S increased PD threshold by 66+/-18.5%(p<0.01), & PT by 42+/-10.5%(p<0.01).Cervical sestimulation S increased PD threshold by 34.9% +/-1% (p<0.05) & PT threshold by28.3% +/-8.2% (p<0.01) over control resting condition. Cervical self-stimulation in grpwith lo

wer SCI S increased P

threshold by 33.8% +/-10.2% PT(p<0.05) & PT threshold by27.2+/-7.6%(p<0.01). In uppeSCI, vaginal self stimulation S increased PD threshold by91.6%+/-32.9

%(p<0.01) & P

T

threshold by 46.1% +/-8.8%(p<0.01) over corresponding ctrl resting condition; cervical self stimulation in this grp increasPD threshold by 72. +/-34.6%(P<0.05), & PT threshoby 36.5% +/-9.6%(p<0.01); S higher increase in PD threshoby vaginal or cervical self stimulation in grp with upper Svs. grp 

with lower SCI (p<0.01 

p<0.05) 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

centimeters; sec = seconds; mg = milligrams; μg = microgra

m; ctrl = control(s); grp = group; pbo = placebo; tx = treatment; hx = history; 

df(s) = difference(s); NS = nonsignificant; pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; (+) = pot.i.d = three times daily; b.i.d = t

wo times daily; NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; IIEF = Index of Erectile Funct

= pain tolerance 
Appendix 

E. Evi

dence Tables (continued)

E-102

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/ 

Beha

vioural/Surgical/other) Outcomes/Follo

w-up

Ev

Martin, 

1983, 

US 

(Ref ID 

1406) 

• Enrolled/ 

evaluated: n=20/ SCI n=12; healthyctrl n=8 

• % males: 100%• Race/ethnicity:

NR 

• Age: healthy grp - 

NR (23-26) y; SCI NR (24-41) y; NR (24-39) y

• Level of Injury: 

T3-T12 n=3; 

T12-

L1 n=2; L2 n=1

• ASIA Level: NR • Duration since 

injury: NR 

• Drop-outs: n=0 • Lost to follo

w-up: 

NR 

• N of sites: 1 • Funding: NIMH

• Study Design: Casecontrol study • Duration: NR • Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment: 

4 * (NOS) 

• Pharmacologic: NR 

• De

vice: Rectal Probe 

Electrostimulator 

• Amplitude: NR• Frequency: 60 Hz, 20 Hz, & 

0.25 Hz 

• Mode/Admin. Route: dorsal 

lithotomy position (after bo

wel movement) intact 

subjects & 1st 5 pts controlled current delivery by themselves

• Other De

vice: NR 

• Surgical: NR 

• Beha

vioural: NR 

• Outco

mes: 

• Anatomic/Physiologic: 

erections with max. tumescence in 1 ctrl pt, 

with 

no seminal emissions or ejaculations; 6/10 SCI achieved erection 

with 20 Hz 

stimulation; surface area & intensity of applied current directly affected extent of RPE-induced peniletumescence; use of 60 Hz & 20 Hz currents ineffective ineliciting erection

• Intervie

ws: verbalized 

descriptions of threshold current sensations included tenesmus, rectum burning sensation, testicular pain resembling intense pressure in rectum, bladder or bo

wel, 

suprabubic midline discomfort, pain at base of penis & sensation of gluteal muscle spasm. 

• Foll

o

w-up: NR

• 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; 

∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo 

positive; A/E = adverse event; NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; IIEF = Index of Erectile Function; Hz = Hertz; 

Institute of Mental Health 
Appendix 

E. Evi

dence Tables (continued)

E-103

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Event

Montague, 

1994, 

US 

(Ref ID 

1736)

• Enrolled/ 

evaluated: n=47: SCI n=12, nontraumatic neurological disorders n=25, peripheral nerve injuries n=10/ n=NR 

• % of Males: 100% • Race/ethnicity: NR • Age: 48 (19-71) y• Level of Injury: NR • ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: July

1987 to July1992 

• Eligi

bility

Criteria: 

• Inclusion: 

Neurogenic Impotence 

• Exclusion: NR • Quality

Assessm

ent:

6/19 (+) reported 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical (n=47): • Type: Prostheses implant: 

AMS 700CX (13) AMS Malleable 600 (10) AMS Ultrex (9) DuraPhase (9) Hydroflex (5) Dynaflex

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 91% 

of pts implanted in study had functioning prosthesis. Penile prosthesis implants (SCI) increased incidence of infection & erosion, so considered alternative tx(e.g., vacuum devices/intracavernous injection therapy) 

• Foll

o

w-up: NR

• A/

E:

• System

prosthemo post infectionremovesemi-rigMalleabdevice (device rpost 6 

w

(device 2 devicea DuraP34 mo pDuraflex mo post rate 4%mechan

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-104

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ Eligi

bility

Criteria 

Intervention 

(e.g., Pharmacologic/ 

De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Richards, 

1993, 

US 

(Ref ID 

1759)

• Enrolled/ evaluated: n=17/ 

n=NR 

• % Males: 100%• Race/ethnicity: 76% 

white 

• Age: NR • Level of Injury: NR (76.4

%

paraplegic; 74.6%complete) 

• ASIA Level: NR • Duration since injury: NR • Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NIDRR; US Dept. 

of Education, & MRRTC 

• Study Design: NCS • Duration: NR • Eligi

bility Criteria: 

• Inclusion: SCI Diagnosed 

by urologist as having neurologically basedimpotence; steady sexual partner; couples with ongoing substance abuse, poor self-esteem, marked relationship instability/discord, or active partner opposition to procedure documented&referred for appropriate tx. If tx recommended follo

wed & successful, 

couple then enrolled. 

• Exclusion: NR • Quality Assessment:

9/19 (+) reported

• Pharmacologic (n

=17):

• Drug name: 

Intracavernous injection of vasoactive (Not specified) 

• Dose: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: NR • De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes:

• Psychological: > overall 

satisfaction subsequent ttx implementation. In SII examination of subscale pre-tx, both partners dissatisfied with frequencof sexual activity (male >females). Males reported self-acceptance vs. partnpre-tx. 

• Sexual Satisfaction: Both 

pts & partner expressed increased satisfaction 

wit

frequency of sexual activpost intervention (injectioHo

wever, SCI males 

reported > improvement sexual pleasure & selfacceptance vs. partners (self acceptance p = 0.05sexual pleasure p = 0.01

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = cha

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

(+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; NIDRR = National Institute on Disability 

MRRTC = Medical Rehabilitation Research &

Training Centre
Appendix 

E. Evi

dence Tables (continued)

E-105

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/ Follo

w-up

Sanchez, 

2001, 

Spain 

(Ref ID 12)

• Enrolled/ evaluated: 

n=170/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 37.3 (19-65) y

• Level of Injury: 

cervical 35 (20.6%); thoracic 99(58.2%); lumbar 30 (17.6%); sacrococcygeal 6 (3.6%) 

• ASIA Level: n=94 

A; n= 14 B; n=27 C; n=29 D 

• Duration since 

injury: 7.7+/-66(0.2-32.7) y 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 16 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: men >18 y

with

SCI 

who overcome period 

of medullary shock, 

with 

stable partner & ED 

• Exclusion: pts with

anatomic deformities of penis; pts in 

whom sexual 

activity not advised (i.e., pts with severe cardiovascular dysfunction such as unstable angina or severe heart failure not controlled with drugs; hypotension (BP<90/50 mmHg); recent hx (less than 3 mo) of stroke or acute myocardial infarction); pts treated 

with any drug or 

therapy for ED that not willing to discontinueduring study; pts treated with drugs containing nitrates; hx of retinitis pigmentosa; severe liver or kidney failure; pts already treated with sildenafil

• Quality Assessment:

8/19 (+) reported 

• Pharmacolo

gic: 

• Drug name: sildenafil • Dose: starting dose 50 mg up

to 100 mg, 30-45 m before start of sexual activity/ 1 x d 

• Duration: NR • Schedule: NR • Mode/Admin. Route: NR • De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic:

150 (88.2%) pts reported improved erection; improvement confirmed by85.3% (99/116) of partners; presence of orgasmic perception pre-tx (p=0.021) & erection grades 3 & 4 (p=0.006) S association with (+) response to sildenafil tx; of total attempts (603) at sexual intercourse made during study, 431 (71.5%) successful; no S 

∆’s seen in 

ejaculatory function after tx; level of SCI, A

SIA, causes 

of SCI, ED duration, age, smoking or drinking habits, pre-tx with caverjet, presence of bulbocavernous reflex & ejaculation not factors predicting response to sildenafil

• Sexual Satisfaction: 

sildenafil S improved pts satisfaction with sexual activity & overall satisfaction 

with sexual life 

(p<0.001) 

• Foll

o

w-up: NR

• 

• 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; 
Appendix 

E. Evi

dence Tables (continued)

E-106

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Schmid, 

2000, 

S

witzerland 

(Ref ID 280) 

• Enrolled/ 

evaluated: n=41/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 36.5 (20-

63) y

• Level of Injury: 

cervical C4-C7: 6; thoracic T1-T12: 19; lumbarL1-L5: 8; conus cauda: 4 

• ASIA Level: NR • Duration since 

injury: 5.9 y (0.5-26) y

• Dropouts: n=5 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: IRP & 

SNF 

• Study Design: NCS 

• Duration: July-December 

1998 

• Eligi

bility Criteria: 

• Inclusion: documented hx of 

chronic SCI (traumatic lesion or spinal disease for > 6 mo) & ED attributable only to SCI 

• Exclusion: pts prone to 

autonomic dysreflexia &/or high BP, kno

wn or 

suspected ED of vascular origin, cardiovascular diseases, bleedingdisorders, hx of stroke, peripheral neuropathy, brain damage, clinical depression, endocrine diseases, pts taking drugs such as nitrates or anticoagulants, which could interact with sildenafil 

• Quality Assessment:

10/19 (+) reported 

• Pharmacologic (n=41): 

• Drug name: oral sildenafil • Dose: 50 mg sildenafil 

given 3 x, doses then adapted, PRN, according to pts self-reports 

• Duration: NR • Schedule: NR • Mode/Admin. Route: NR 

• De

vice: vibrator: El-star 

Elektronik (n= 41) 

• Amplitude: NR• Frequency: N

R

• Mode/Admin. Route: NR • Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic: 38 pts 

(93%) reported improvederections (grade 3-4) post sildenafil permitting sexualintercourse 1 h post intake of drug; using IIEF questionnaire: erectile function improved fro

m

a mean score of 9.2+/-4.4 to 25.4+/-4.2 (p<0.05); orgasm & ejaculation function slightly but NS increased from a mean of 3.8+/-2.7 to 5.2+/-3.7; NS 

∆’s 

in sexual desire post tx from a mean of 6.7+/-2.3 to 7.5+/-1.9 

• Sexual Satisfaction: using 

IIEF questionnaire: intercoursesatisfaction improved from mean of 4.5+/-2.5 to 10.5+/-2.0 (p<0.05); overall sex life satisfaction improved from a mean of 4.2+/-2.0 to 7.8+/-1.6 (p<0.05) 

• Foll

o

w-up: questionnaires 

completed pre-tx & post tx3 mo

• Length: NR • Duration: NR • Results: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; IRP = Internation

Paraplegia; SNF = S

wiss National Science Foundation 
Appendix 

E. Evi

dence Tables (continued)

E-107

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Even

Sidi, 

1987, 

US 

(Ref ID 

399) 

• Enrolled/ 

evaluated: n=66/ n=NR 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 35.8 (18-

61) y

• Level of Injury: 

14 cervical, 32 thoracic & 6 lumbar, 29 UMN, 21 complete 23 LMN, 15 complete 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=14 • Lost in follo

wup: NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS 

• Duration: 1 y

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality

Assessm

ent: 13/19 

(+) reported 

• Pharmacologic (n

=66):

• Drug name:averine 

hydrochloride (30 mg/ml), or a combination of papaverine (25 mg/ml) & phentolamine mesylate (0.83mg/ml) 

• Dose papaverine (25 

mg/ml) & phentolamine mesylate (0.83mg/ml) 2 xwk

• Duration: NR • Schedule: NR • Mode/Admin. Route • De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic:

Average dose required to induce functional erection: Papaverine/phentolamine for 13 UMN 0.42+/-0.246, for 9 LMN 0.37+/-0.299. Papaverinefor 10 UMN 0.403+/-0.183, for 10 LMN 0.32+/-0.166. Dose ofpapaverine/phentolamine in 10pts (6 UMN, 4 LMN) 

who did 

not respond to papaverine alone: 0.395+/-0.37 & 0.4+/-0.297, respectively. No S df inaverage required doses observed between pts 

with 

UMN & LMN lesions or bet

ween thoracic, cervical & 

lumbar in both grps 

• Foll

o

w-up: 

• Length: NR • Duration: NR • Results: Last f/u result in 

n=52(total): 15 (29%) not practising vasoactive intracavernous therapy for various reasons. Frequency ofuse for 37 (71%) practicing vasoactive intracavernous pharmocotherapy ranged from< 1 x mo to 1-2 x

wk.

• A/

E:

• System

that req(2 discorespondComproblood flmellitus disease penile p

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; UMN = upp

= lo

wer motor neuron 
Appendix 

E. Evi

dence Tables (continued)

E-108

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d)

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

A

Events/C

Sipski, 

1995, 

US 

(Ref ID 

578)

• Enrolled/evaluated: 

n=21:13 SCI/ 8 AB/ n=NR 

• % Males: 0% (all 

female) 

• Race/ethnicity: NR • Age: SCI 30 (25-

44) y; AB 36 (24-49) y

• Level of Injury: n=9 

C4-7, n=4 T2-5 

• ASIA Level: A 

n=13(tetraplegic) 

• Duration since 

injury: (12-232) mo 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NIH

• Study Design: Casecontrol Study 

• Duration: NR (78 m 

study protocol)

• Eligi

bility Criteria: 

• Inclusion: regular 

menstrual cycles, no hx of gynecological or neurological surgery,no psychiatric disorders & medicallystable. SCI pts of ASIA A tetraplegia of above T

• Exclusion: NR • Quality Assessment:

6 * (NOS) 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral (n=21): 

• Type Erotic A/V & erotic 

A/V combined with manual stimulation of clitoral region 

• Duration 6 m baseline, 12

m AV stimulation, 6 m baseline, 12 m of AV +manual stimulation, & 6 m final baseline

• Frequency: N

R

• Outco

mes: 

• Anatomic/Physiologic: • VMP: Baseline 2-5 all S > 

vs. initial baseline (p<0.05) indicating increasing cumulativeexcitation effect; No S df in baselines for SCI; ABs had S > mean baseline VPA vs. complete SCI subjects (p=0.03); S increase in VPA in response to A/V stimulation over baseline (p=0.03); addition of manual stimulation to AV resulted in (+) response in VPA in all pts 

• Subjective arousal: AB 

pts sho

wed S > levels vs. 

SCIs (p=0.04); arousal levels during 

A/V 

stimulation combined 

with 

manual stimulation S df bet

ween AB & SCI 

(p=0.04) 

• Intervie

ws/ Other: 

Divorce: 1 SCI, 3 AB 

• Foll

o

w-up: NR

• A/

E: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

ctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; 

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

= t

wo times daily; (+) = positive; A/E = adverse event; NOS = Ne

wcastle Ottawa Scale; A/V = audio visual; ED = erectile dysfunction; IIE

Erectile Function; VPA = vaginal pulse amplitude; NIH = National Institute of Health 
Appendix 

E. Evi

dence Tables (continued)

E-109

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioural/Surgical/other) Outcomes/Follo

w-up

Sipski, 

1995, 

US 

(Ref ID 

571)

• Enrolled/ 

evaluated: n=35 (25 SCI; 10 AB)/NR 

• % Males: 0% (all 

female) 

• Race/ethnicity:

NR 

• Age: SCI 32 (NR) 

y; A

B 34 (NR) y 

• Level of Injury: 

n=20 C4-7, n=5 T1-5

• ASIA Level: NR • Duration since 

injury: 98 (10-242) mo 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NIH

• Study Design: Casecontrol Study 

• Duration: d 2 of 3 d 

study protocol

• Eligi

bility Criteria: 

• Inclusion: 1. normal 

menstrual cycles, 2. no gyne- or neurological surgery,3. free from psychiatric disorders, 4. medically stable 

• Exclusion: NR • Quality Assessment:

5 * (NOS) 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Other De

vice (n=35): 

• Type: Physiological 

measurements - PPS 

• Manufacturer • Surgical: NR 

• Beha

vioral (n=35): 

• Type: A/V (sexually explicit 

video), manual & vibratorystimulation (

with vaginal 

lubricant) to reach orgasm 

• Duration: up to 75 m • Frequency: N

R

• Outco

mes: 

• Anatomic/Physiologic: • NS df bet

ween any pts grps for HR, 

SBP, & DBP. HR & RR in AB at orgasm>baseline (HR: p=0.002 & RR: p=0.03); for SCIs S increase in HR (p=0.005), RR (p=0.001), &SBP (p=0.05) at orgasm 

• The ability to achieve orgasm S &(+) 

related to pts pinprick sensory scores in T11-L2 dermatomes(r=0.49), pinprick sensory scores in S3-

S5 

dermatomes(r=0.048), light touch sensory scores in T11-L2 dermatomes(r=0.47) & light touch sensory scores in S3-S5 dermatomes(r=0.45); all p<0.01. 

• Whether pts had orgasm seemed 

related to SCI but not to degree or type of SCI. 

• S df bet

ween neurologically intact pts 

(mean time to orgasm=15.11 m) & pts with no lower extremity function(mean time to orgasm =34.63) 

• Psychological: NR • DSFI: SCIs scored S higher on sexual 

role subscale (m=52.80) vs. Abs (m38.89) (p=0.005). ABs indicated >sexual satisfaction (m=54.89) vs. SCIs (m=48.24) (p=0.04). 

• Foll

o

w-up: NR

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; 

∆ = change; S = significant; NS = 

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo 

positive; A/E = adverse event; NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; IIEF = Index of Erectile Function; DSFI = Dero

Function Inventory; PPS = photoelectric pulse sensor; A/V = audio visual; HR = heart rate; SBP = systolic blood pressure; DBP = diastol= respiratory rate; NIH = National Institute of Health
Appendix 

E. Evi

dence Tables (continued)

E-110

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

Sipski, 

1996, 

US 

(Ref ID 

562)

• Enrolled/ evaluated: 

n=20: n=10 SCI; n=10 control/ n= NR 

• % Males: 0% (all 

female) 

• Race/ethnicity: NR • Age: SCI 30 (NR) y;

ctrl 35 (NR) y

• Level of Injury: n=6 

C4-6, n=3 T2-5 

• ASIA Level: n=10 A 

(tetraplegic) 

• Duration since 

injury: 93 (12-242) mo 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NIH

• Study Design: Casecontrol study 

• Duration: 3 d protocol

• Eligi

bility Criteria: 

• Inclusion: All subjects 

require clearance from gynecologist & verification of absence of gynecologicproblems. Monitoring of menstrual cycles for a min of 2 mo pre study participation. All study testing performed bet

ween d 

16-21 of menstrual cycle

• Exclusion: NR • Quality Assessment:

7 * (NOS) 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Other De

vice

(n=20): 

• Type 

Sphincter

EMG: Dantec Couterpoint device(no.9018A0041) 

• Manufacturer Dantec 

Medical Inc., Grass 

Instruments, Ferrall Instruments 

• Surgical: NR 

• Beha

vioral (n=20): 

• Type: manual 

stimulation 

• Duration: 6 m 

baseline +12 m of Stroop (distraction test), +6min of baseline, + 12 m of Stroop test combined with manual stimulation, +6 m baseline +12 m of baseline followed by12 m masturbation & 6 final m of baseline 

• Frequency: N

R

• Outco

mes: 

• Anatomic/Physiologic: • Comparison of VPA 

within grps 

sho

wed S df between baseline 

conditions for AB subjects. Baseline 3 to 5 S greater vs. initial baseline (p<0.05) indicating increasing cumulative excitation effect. NS df in baselines for complete SCI. Normal subjects S greater mean baseline VPA (m=8.95) vs. complete SCI (m=4.71)(p<0.03) 

• Psychological: 

• NS 

∆ in complete SCIs in subjective 

arousal 

with performance of distracting 

task in conjunction 

with manual genital 

stimulation, ho

wever showed S 

increases in arousal when distracting task eliminated. 

• Foll

o

w-up: NR

• 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignificant; df

participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = po

NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; IIEF = Index of Erectile Function; VPA = vaginal pulse amplitude; NIH = Natio
Appendix 

E. Evi

dence Tables (continued)

E-111

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention 

(e.g.,Pharmacologic/

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

Sipski, 

2001, 

US 

(Ref ID 

462) 

• Enrolled/ evaluated: 

Arousal study: 68 SCI, 21 AB; Orgasm study: 66 SCI, 66 ctrl/ n=NR 

• % Males: 0% (all 

female) 

• Race/ethnicity: NR • Age: Arousal study - 

SCI 33.9 (NR) y; ctrl 34.1 (NR) y. Orgasm study - SCI 32.8 (NR) y; ctrl (NR) y

• Level of Injury: 

Arousal: C2-L4, 55 UMN (S3-5), 13 LMN, 41 incomplete & 27 complete Orgasm: NR, 12 LMN (S2-5), 50 UMN, 40 complete & 22 incomplete

• ASIA Level: NR • Duration since injury: 

127 (15-494) mo 

• Dropouts: n=6 • Lost in follow-up: NR • N of sites: 1 • Funding: NIH 

• Study Design:

Case-control study

• Duration: 2 d 

protocol: d 1 pre study testing, d 2 - 78 m arousal or a 75 m orgasm protocolperformed 

• Eligi

bility

Criteria: 

• Inclusion: NR • Exclusion: 

neurological surgery withaltered structure of nervous system, genitalsurgery, irregular or absent menstrual cycles, & active medical or psychiatric problems 

• Quality

Assessm

ent: 5 * 

(NOS) 

• Pharmacologic

(n=x): NR 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral (All pts) 

• Type: A/V erotic

stimulation/vaginal/ manual clitoral stimulation (until arousal or orgasm reached) 

• Duration: 78 m• Frequency: Arousal 5 

x 6 m baseline periods alternated with 4 stimulusconditions: 2 x 12 m A/V follo

wed by 2 x

12 m AVM: Orgasm: up to 75 m manual stimulation 

• Outco

mes: 

• Mean VPA: In ctrl subjects (n=21) S 

increase in VPA 

with 28.4 vs. baseline 

23.0 (p<0.001). SCI: S increase in VPA with 15.7 vs. 13.9(p<0.001). 

• Orgasm study results: Historically, 55% of 

SCI reported orgasmic ability post-SCI, vs. 44% orgasmic in laboratory. (100% of ctrl reported historically & laboratory orgasm). No S dfs in orgasmic ability between SCI according to S

S at 

T11-L2 & S2-S5 

dermatomes, completeness of injury & UMN or LMN dysfunction. 

• Differences in genital responsiveness to 

A/V based on degree of sensoryimpairment affecting T11-L2 dermatomes. Regardless of level of injury, marked dfs in response observed based on degree of combined light touch & in prick sensory preservation at

T11-L2 dermatomes. No 

dfs in genital responsiveness occurred when women classified based on sensory preservation in sacral (S2-S5) or thoracic (T6-

T9) dermatomes. 

• Subjective Characteristic of Orgasm: Data 

reporting location of stimulation to reach orgasm similar for both grps of SCI vs. ctrl 

• DSFI:SCIs scored S lo

wer (m=46.8) vs. 

ctrl (m=53.0)(p=0.02); SCIs scored lo

wer 

vs. ctrl in body image (p=0.02); SCIs S less sexually satisfied vs. ctrl on specific & global measures of sexual satisfaction. 

• 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

= group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; 

∆ = change; S = significant; NS = nonsignificant; 

pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = two times daily; (+

adverse event; NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; DSFI = Derogastis Sexual Function Inventory; IIEF = Index o= audio visual; VPA = vaginal pulse amplitude; UMN = upper motor neuron; LMN = lo

wer motor neuron; NIH = National Institute of Healt
Appendix 

E. Evi

dence Tables (continued)

E-112

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

E

Sonksen, 

1992, 

Denmark 

(Ref ID 

356)

• Enrolled/evaluated: 

n=17/ n=NR

• % Males: 100%• Race/ethnicity: NR • Age: 41 (19-51) y• Level of Injury: C2-

L3, n=13 complete n=4 incomplete

• ASIA Level: NR • Duration since injury: 

7 (1-27) y 

• Dropouts: n=0 • Lost in follow-up: NR • N of sites: 1 • Funding: NR 

• Study Design: 

NCS

• Duration: NR

• Eligi

bility Criteria: 

• Inclusion: (+) 

erection response to 5-60 mg of papaverine injection sufficient for vaginal penetration

• Exclusion: NR • Quality

Assessm

ent: 7/19 

(+) reported 

• Pharmacolo

gic (n

=12): 

• Drug name: Papaverine • Dose: 5-60 mg • Duration: NR • Schedule: NR• Mode/Admin. Route: NR • De

vice: NR 

• Oth

er De

vice:

• Type: Transcutaneous nitroglycerin plaster (10mg/24 h) 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic:

12/17 responded (+) to nitroglycerine test: 5 complete response (full rigidity), 7 partial response (some rigidity & /or tumescence) & 5 failed to respond. Medianplaster application time: 75 m. Duration of erections in 5 with complete response: 20-45 m post removal of plaster 

• Foll

o

w-up: NR

• A/

E

• Sys

2/6 ana

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-113

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

Eve

Tang, 

1995, 

Republic of

China 

(Ref ID 314) 

• Enrolled/ 

evaluated: n=15/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 38.5 (25-50) y• Level of Injury: C5 

1; 

T4-T12 6; L1-L3 

8 (n=8 incomplete lesion) 

• ASIA Level: NR • Duration since 

injury: mean 6.3 y

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

12/19 (+) reported 

• Pharmacolo

gic (n

=15): 

• Drug name: prostaglandin 

E1 

• Dose: starting at 0.5 mg 

with increased dosage to achieve a rigid erection of grade 5 & lasting for at minimum 20 m (a max.dosage of 20 mg 

would be 

applied) 

• Duration: NR • Schedule: max. 

recommended injection frequency 2 x wk

• Mode/Admin. Route 

intracavernous injection 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic: 

• pre-injection 

Schramek 

grading: grade 1 - 8 (53%) pts; grade 2 - 1(7.4%) pt; grade 3 - 2 (13.4%) pts; grade 4 - 1 (6.7%) pts; grade 5 - 3 (20

%) pts; 

post-injection Schramek grading: grade 5 - 14 (93.3%) pts; grade 2 - 1 pt (6.7%); erectile condition post-tx found to be S higher vs. pre-tx (p<0.001); no S dosage effect of prostaglandin E1 found in df bet

ween pre-tx

& post-tx

• Foll

o

w-up: NR

• A/

E:

• Local: 

complainjectio

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix 

E. Evi

dence Tables (continued)

E-114

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention (e.g., 

Pharmacolo

gic/De

vice/ 

Beha

vioral/Surgical/other) Outcomes/Follo

w-up A

d

v

erse 

van der 

Aa, 

1995, 

Netherlands

(Ref ID 

 1172)

• Enrolled/ 

evaluated: n=17/n=NR 

• % Males: 

82%(14) males,18%(3) females 

• Race/ethnicity:

NR 

• Age: NR (21-54) y• Level of Injury: C5 

16 T1-10, All complete lesion 

• ASIA Level: NR • Duration since 

injury: (1-15) y 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: NCS 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: Complete 

lesion of spinal cord, no previous bladder outlet surgery,incontinence, & at least 12 mo postinjury

• Exclusion: NR • Quality

Assessm

ent: 3/19 

(+) reported 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Other De

vice (n=17): 

Finetech-Brindleybladder control system 

• Type 

N

R

• Manufacturer NR • Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: • Sustained full erection in all 

(n=14) male pts, in 12 pts bystimulation of S2 anterior roots; in 2pts by stimulating S3 anterior roots 

• A

dditional Outcomes:

Bladder capacity: increase capacity postoperation by>100 ml in 2 pts& >400 ml in 8 pts; Continence: all but 1 continent; Bo

wel function: 

13 pts using implant for defaecation

• Foll

o

w-up: 

• Length: 1-6 y (longest 

follo

wup: 4 y) 

• Duration: NR • Results: Although loss of 

erection is expected post posterior rhizotomy, in this study all male pts managed to achieve erection, usually by stimulating S2 roots

• A/

E:

• Other: 

posterireflex e

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-115

Evidence Table 5: Evidence from other study designs regarding sildenafil & other remediation for the treatment of sexual (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ 

Eligibility Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Behavioral/Surgical/other) Outcomes/Follow-up Adv

van der Aa, 

1999, 

Netherlands

(Ref ID 

1075)

• Enrolled/ evaluated: 

n=38/NR 

• % Males: 87%(33) 

male; 13%(5) female 

• Race/ethnicity: NR • Age: NR (18-59) y• Level of Injury: 9 

C4-6 29 T1-12 (all complete) 

• ASIA Level: NR • Duration since 

injury: (1-39) y 

• Dropouts: n=3 • Lost in follow-up: 

n=2 

• N of sites: 1 • Funding: NR 

• Study Design:

NCS 

• Duration: NR 

• Eligibility

Criteria: 

• Inclusion: 

Completeness of lesion & intact efferent nervesupply to bladder wall minimum 12 mo post-injury

• Exclusion: NR • Quality

Assessment:5/19 (+) reported

• Pharmacologic: NA 

• Device: NA 

• Other Device (n=38): 

• Type Brindley bladder 

controller 

• Manufacturer: NR • Surgical: NA 

• Behavioral: NA 

• Outcomes: 

• Anatomoic/Physiologic: • Implant driven sustained full

erection achieved in 29/33 males (by stimulating S3 anterior roots in 2 pts, & in 27pts by stimulation S2 anterior roots. Erection not achieved in4 pts. BC (n=37): increase in BC observed in all (due to posterior rhizotomy), in 15more than 200 cc & in 14 pts more than 400 cc. Residual urine volume (n=37): No increase observed postoperation. 27 pts use implant for bowel function. Decrease in urinary tract infection rate postoperation 

• Psychological: NR • Sexual Satisfaction: NR • Pt logs/diaries: NR • Interviews: NR • Follow-up: NR

• A/E

• Sys

with2 demfailuimpfluid 

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg = microgram; tx = treatment; hx = histo

significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyze

b.i.d = two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; BC = bladder cap
Appendix 

E. Evi

dence Tables (continued)

E-116

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/Surgical/

other) Outcomes/Follo

w-up

Even

Whipple,

1996, 

US 

(Ref ID 

1713)

• Enrolled/ 

evaluated: n=16/ n=NR 

• % Males: 0% (all 

female) 

• Race/ethnicity:• Age: SCI 37.2 

(NR) y; ctrl 45.4 (NR) y

• Level of Injury: 

at or belo

w T6

• ASIA Level: NR 

(all complete) 

• Duration since 

injury: 12.4 (2-27) y

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: Casecontrol Study 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: SCI grp 

complete ASIA A SCI>1y, with intact uterus & cervix

• Exclusion: psychosis, 

depression, or hx of cystocele, hysterectomy

• Quality Assessment:

6 * (NOS) 

• Pharmacolo

gic: NR 

• De

vice: NR 

• Other De

vice (n=16): 

• Type A pressure transducer 

embedded in holder behind & aluminum head (Providing self-application to vaginal 

wall or to cervix) 

• Manufacturer: NR • Surgical: NR 

• Beha

vioral: 

• Type vaginal selfstimulation, cervical selfstimulation & hypersensitive 

area self-stimulation 

• Duration: 90 m• Frequency: Each 

experimental condition performed once, preceded & follo

wed by rest period

• Outco

mes: 

• Anatomic/Physiologic: 

multiple orgasms in 1 SCI T11 from vaginal self stimulation, she had increasein SBP, one S

CI T8 had six

orgasms in lab, t

wo from 

vaginal self -stimulation, one from cervical self-stimulation, & three from hypersensitive area stimulation 

• Psychological: NR • Sexual Satisfaction: NR • Pt logs/diaries: NR • Divorce: 2 in SCI & 3 in ctrl 

grp 

• A

dditional Outcomes:

higher incident of SCI women living 

with partner vs. 

women 

without SCI. BP 

increased S in response to vaginal & cervical selfstimulation only in complete SCI belo

w T10. No 

∆ in HR 

in SCI grp. 3 /16 in SCI, n=1 as high as T7 & n=1 without SCI self reported orgasms during laboratory study. 

• Foll

o

w-up: NR

• A/

E: 

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

grp = group; pbo = placebo; mg = milligrams; μg = microgra

m; tx = treatment; hx = history; ∆ = change; S = significant; NS = nonsignific

difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d = t

wo 

positive; A/E = adverse event; NOS = Newcastle Ottawa Scale; ED = erectile dysfunction; IIEF = Index of Erectile Function; BP = blood p

heart rate; SBP = systolic blood pressure 
Appendix 

E. Evi

dence Tables (continued)

E-117

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/Surgical/

other) Outcomes/Follo

w-up

Eve

Zaslau, 

1999, 

US 

(Ref ID 

283) 

• Enrolled/ 

evaluated: n=28/ n=37 

• % Males: 100%• Race/ethnicity:

NR 

• Age: 43.7 (24-72) 

y 

• Level of Injury: 13 

cervical 15 thoracic & 9 lumbar 

• ASIA Level: NR • Duration since 

injury: 8.6 y (1-20) y 

• Dropouts: n=5 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR

• Study Design: NCS 

• Duration: May 1994 

to March 1997 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

10/19 (+) reported 

• Pharmacologic (n

=28):

• Drug name mixture of PGE1 & papaverin

• Dose: post initial test dose 

of 0.5 cc, doses adjusted in increments of 0.05 cc, up to a maximum of 1.0 cc 

• Duration: NR • Schedule: 43% of pts inject 

themselves >1 x 

wk

• Mode/Admin. Route: 

intracavernous injectable. papaverine 1500 mg/50 ml is combined 

with PGE-1 

1000 miug/2ml; normal saline (48cc) is added to mixture, then subdivided into 10 vials 

with 10 ml of 

vasoactive substances/vial. Each vial contains 30 mg/ml papaverine & 10 miμg /ml of PGE-1 

• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Ph

ysiologic: 

• Erection: 85% of pts rated 

pharmacologically produced erections as good or excellent with a mean erection of 43 m; vs. all pts reported never or sometimes being able to ejaculate, 21% of those treated became able to ejaculate > 50% of time, 60%reported being al

ways or 

almost al

ways successful at 

intercourse representing a S improvement from 93% reporting successful intercourse occurring never or almost never; 35% pts reported being able to have successful intercourse 25-50% of time 

• Psychological: NR • Sexual Satisfaction: 77% of 

pts moderately or extremely satisfied 

with therapy; 90% of

participants would recommend this tx to a friend 

• Pt logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up: 

• Length: quarterly f/u visits • Duration: mean f/u of 15 mo • Results: NR

• A/

• Lo

repdissit

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

= control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; miμg/μg = microgram; tx = treatment; hx change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluatet.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Fun
Appendix 

E. Evi

dence Tables (continued)

E-118

E

vidence Table 5: E

vidence fro

m other stu

d

y designs re

gardin

g sild

enafil & other remediation for the treatm

ent of sexual dysfu

after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/ 

Eligi

bility Criteria 

Intervention 

(e.g.,Pharmacologic/ 

De

vice/Beha

vioral/ 

Surgical/other) Outcomes/Follo

w-up

A

d

v

e

Events/Com

Zasler, 

1989, 

US 

(Ref ID 

386)

• Enrolled/ evaluated: 

n=20/ n=NR 

• % Males: 100%• Race/ethnicity: NR • Age: 40 (21-65) y• Level of Injury: C4-

L2: 9 cervical 10thoracic 1 lumbar, n=13 complete n=7 incomplete 

• ASIA Level: NR • Duration since 

injury: ≥ 1y post 

• Dropouts: n=2 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR

• Study Design: 

NCS 

• Duration: 1y

(included intervention +follo

w-up) 

• Eligi

bility

Criteria: 

• Inclusion: At least 

1 y post injury, with neurogenicimpotence, steady partner

• Exclusion: NR • Quality

Assessm

ent:

13/19 (+) reported 

• Pharmacolo

gic:

NR 

• De

vice: Synergist 

erection system) (n=20) 

• Manufacturer 

Synergist Ltd.,Fannin, Houston, T

X

• Frequency: N

R

• Mode/Admin. Route 

Couples assessed for first 

questionnaire after 20 times use ofdevice. Usage of intervention device varied from several times per mo to as frequently as daily during f/u period 

• Oth

er De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: NR • Reflexogenic erectile 

capability: absent in 4 pts, partial tumescence (insufficient for vaginal penetration), & n=6 complete. Snap-gauge assessment: n=8 

without any 

broken bands, n=4 

with one, 

n=2 

with t

wo & n=6 

with all 

three band broken. This assessment correlated well(r=0.92, p<0.001) 

with

subjective reports of erectile capability

• Psychological: NR • Sexual Satisfaction: See 

follo

w-up 

• Pt logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up (n=15 pts & n=14 

partners): Sexual Satisfactionquestionnaire

• Duration: Baseline & at 6 mo • Results: quality of vaginal 

intercourse rated very good toexcellent vs. to previous best since injury(r=0.78, p<0.001), 2 couples rated as fair to good (orogenital preference)

• A/

E:

• Local: iscomf

intercourse 

w

device in n=1partner reporcould feel seaSeveral episomicturition by resulting in lotumescent stamaintenance urine within d

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; m = minu

hours; ctrl = control(s); grp = group; pbo = placebo; NCS = non-comparative case series; mg = milligrams; μg/miμg = microgram; tx = trehistory; ∆ = change; S = significant; NS = nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualifie

= n analyzed; t.i.d = three times daily; b.i.d = t

wo times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index 

Function 
Appendix 

E. Evi

dence Tables (continued)

E-119

E

vidence Table 6: E

vidence fro

m conference proceedin

gs regardin

g sildenafil & 

other remediation for the treatment of sexual d

indi

viduals after SCI 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioral/Surgical/other) Outcomes/Follo

w-up

A

d

v

Com

Anon

y

mous,

1999 UK 

(Ref ID 

2071) 

• Enrolled/ 

evaluated: n=26/n=26 

• % males: 100%• Race/ethnicity:

NR 

• Age: NR (21-49) 

y 

• Level of Injury: 

T6-L5 

• ASIA Level: NR • Duration since 

injury: NR 

• Drop-outs: n=0 • Lost in Followup: NR 

• N of sites: 1

• Funding: Pfizer

• Study Design:

Abstract from conference proceeding 

• Duration: 28 d 

• Eligi

bility Criteria: 

• Inclusion: Ability to 

achieve at min.moderate reflexogenic erectile response to PVS 

• Exclusion: NR • Quality Assessment:

NA 

• Pharmacolo

gic (n=26):

• Drug name: sildenafil /pbo• Dose: 50 mg • Duration: 28 d for both tx • Schedule: 1 hr pre sexual 

activity but not > 1x per d 

• Mode/Admin. Route: NR • De

vice: NR 

• Other De

vice: NR 

• Surgical: NR 

• Beha

vioral: NR

• Outco

mes: 

• Anatomic/Physiologic: 

Improved quality of erections post sildenafiltx: After 28 d, 75% of sildenafil-tx & 7

% of pbotx men reported improved 

erections. Sildenafil grp had > % of successful attempts at sexual intercourse (30% vs.15%). 

Total of 67% of 

sildenafil grp 

wanted to 

continue tx vs. 15% of pbo grp. 

• Foll

o

w-up: NR 

• A/

E:

• Syste

possibrelatedysperespirNeithe

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

cm = centimeters; sec = seconds; mg = milligrams; μg = microgram; ctrl = control(s); grp = group; pbo = placebo; RCT = randomized clitreatment; hx = history; ∆ = change; S = significant; df(s) = difference(s); N

S = nonsignificant; pts = participants; n = n of participants; enr

qualified; evaluated = n analyzed; (+) = positive; A/E = Adverse Events; HR = heart rate; BP = blood pressure; t.i.d = three times daily; bdaily; ED = erectile dysfunction; IIEF = Index of Erectile Function; PVS = penile vibratory stimulation 
Appendix E. Evidence Tables (continued)

E-120

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (continued) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ 

Eligibility Criteria 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

A

Events/

Bodner, 

1998, 

US 

(Ref ID 

3021) 

• Enrolled/ 

evaluated: n=15/NR 

• % male: 100%• Race/ethnicity: NR • Age: NR • Level of Injury: NR • ASIA Level: NR • Duration since 

injury: all ≥ 1y

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design:

Abstract from conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: • Inclusion: SCI ≥1 y

post injury

• Exclusion: NR • Quality

Assessment: NA 

• Pharmacologic (n=15): 

• Drug name: alprostadil 

(MUSE) 

• Dose: 125-1000 μg • Duration: NR • Schedule: NR • Mode/Admin. Route: 

intraurethral admin. Byphysician or pts 

• Device: NR 

• Other Device: Type: Actis 

ring 

• Surgical: NR • Behavioral: NR

• Outcomes: • Anatomic/Physiologic: 

NR 

• Psychological: NR • Sexual Satisfaction: 

only effective dose 1000 μg, 3/15 used MUSE at home; 0/15 satisfied with quality of erection vs. IC tx (rate of 50-60% vs. IC tx); hypotension in 8/17 used MUSE without Actis ring; 7/15 used Actis ring with no transient hypotension 

• Patient logs/diaries: NR • Interviews: NR • Follow-up: NR

• A/E:• Local: n

priapis

• System

hypote

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; 

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; IC = intracavernosal
Appendix E. Evidence Tables (continued)

E-121

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ Eligibility

Criteria 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Even

Clontz, 

1999, 

US 

(Ref ID 

3023) 

• Enrolled/ 

evaluated: n=12/NR 

• % males: 100%• Race/ethnicity:

NR 

• Age: 40 (21-54) 

y 

• Level of Injury: 

n=5 cervical; n=5 thoracic; n=2 lumbar; (8/12 incomplete; 4/12complete) 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: Abstract 

from conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: NA

• Pharmacologic (n=12): • Drug name: sildenafil • Dose: 50 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: 5 

samples of sildenafil/ pts 

• Device: NR 

• Other Device: NR 

• Surgical: NR • Behavioral: NR

• Outcomes: • Anatomic/Physiologic: 

NR 

• Psychological: NR • Sexual Satisfaction: 

mean IIEF scores of satisfaction (4 wk f/u; range 1-10) male, 8.9 female, 9.0; erectile function improved in 9/12 (75%); 3/12(25%) experienced side effects 

• Patient logs/diaries: • Interviews: • Follow-up: • Duration: NR • Result: all pts (n=12) 

continued to use sildenafil

• A/E• Syst

1/12

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = hou= control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; NS 

df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-122

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ 

Eligibility Criteria 

Intervention 

(e.g., Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Ad

Events/C

Kier, 

1999, 

US

(Ref ID 

3033) 

• Enrolled/ 

evaluated: n=29/NR 

• % males: 100%• Race/ethnicity:

NR 

• Age: 39.3 (21-

54) y

• Level of Injury: 

n=11 cervical, n=14 thoracic, n=4 lumbar; 17/29 complete lesion, 12/29incomplete lesion 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in followup: NR • N of sites: 1 • Funding: NR

• Study Design:

Abstract from conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality

Assessment: NA 

• Pharmacologic (n=29): • Drug name: sildenafil • Dose: 50 mg • Duration: NR • Schedule: NR • Mode/Admin. Route: 5 dose 

of 50 mg /pt 

• Device: NR 

• Other Device: NR 

• Surgical: NR 

• Behavioral: NR

• Outcomes: • Anatomic/Physiologic: NR • Psychological: NR • Sexual Satisfaction: IIEF 

post 4 wks, improvement in ED - 83%(24/29); mean ∆ in IIEF 18.3; range –39 to +55; mean pt & partner satisfaction, 8.29, & 8.46, respectively (range 1-10) 

• Patient logs/diaries: NR • Interviews: NR • Follow-up: • Length: NR • Duration: NR • Results: 25/29 (86%) 

found sildenafil effective & continue to use tx at home 

• A/E:• Systemic: he

dizziness (3

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; 

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-123

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention (e.g., 

Pharmacologic/Device/ 

Behavioral/Surgical/other) Outcomes/Follow-up

Events/

Laschke, 

2002, 

Germany

(Ref ID 

3041) 

• Enrolled/ 

evaluated: n=69/n=NR 

• % Males: 

100% 

• Race/ethnicity:• Age: NR • Level of Injury: 

NR 

• ASIA Level: 

NR 

• Duration since 

injury: NR 

• Dropouts: n=0 • Lost in followup: NR • N of sites: 1 • Funding: NR 

• Study Design:

Abstract from conference proceeding – interventional (time series before/after trial) 

• Duration: 12 wk /IIEF 

questionnairecompleted at 4, 8 & 12 wk

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment:

NA 

• Pharmacologic (n=69): • Drug name: sildenafil • Dose: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: NR • Device: NR • Other Device: NR • Surgical: NR • Behavioral: NR

• Outcomes: 

• Anatomic/Physiologic: 

erection & overall sexual satisfaction improvement of approx. 90% in responder grp 

• Follow-up: • Length: 2-3 mo f/u • Results: scores on IIEF 

NS ∆’s in efficacy

• A/E:• Systemi

headach10% had chromat

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; m = minu

= minute; ctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = si

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function
Appendix E. Evidence Tables (continued)

E-124

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention (e.g., 

Pharmacologic/Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Even

Raviv,

2000, 

Israel 

(Ref ID 

3006) 

• Enrolled/ 

evaluated: n=60/NR 

• % males: 100%• Race/ethnicity:

NR 

• Age: 35.2 (19-

58) y

• Level of Injury: 

35 UMN, 13-35quadriplegic; 25LMN 

• ASIA Level: NR • Duration since 

injury: 26.8 (4-56) y

• Dropouts: (n=0) • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: Abstract 

from conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment:

NA 

• Pharmacologic (n=60): • Drug name: sildenafil • Dose: starting dose of 50

mg increased to 100 mg (25 mg in 13 quadriplegic pts) 

• Duration: NR • Schedule: NR• Mode/Admin. Route: oral• Device: NR 

• Other Device: NR 

• Surgical: NR • Behavioral: NR

• Outcomes: • Anatomic/Physiologic: NR • Psychological: NR • Sexual Satisfaction: UMN 

grp success rate as defined by improvement in ability to have sexual intercourse, & wish to continue tx, 31/35(89%); in UMN grp, 18/25(72%); overall success rate 49/60(82%); IIEF score improvement from mean, 5.48 to 6.55 (p<0.001) 

• Patient logs/diaries: NR • Interviews: NR • Follow-up: NR

• A/E

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; 

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function; UMN = upper motor neu

motor neuron 
Appendix 

E. Evi

dence Tables (continued)

E-125

E

vidence Table 6: E

vidence fro

m conference proceedin

gs regardin

g sildenafil & 

other remediation for the treatment of sexual d

indi

viduals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessm

ent/Eligi

bility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Beha

vioural/Surgical/other) Outcomes/Follo

w-up

Even

Shenot, 

1999, 

US 

(Ref ID 

3024) 

• Enrolled/ 

evaluated: n=29/NR 

• % males: 100%• Race/ethnicity: NR • Age: 26.3 (NR) y• Level of Injury: 

C5-L1 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follo

w-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: 

Abstract from conference proceeding –interventional (time series before/after trial) 

• Duration: NR 

• Eligi

bility Criteria: 

• Inclusion: NR • Exclusion: NR • Quality Assessment:

NA 

• Pharmacolo

gic (n

=29): 

• Drug name: sildenafil • Dose: starting dose 50 mg; 

titrated to 100 mg if submaximal result obtained with 50 mg 

• Duration: NR • Schedule: NR• Mode/Admin. Route: oral• De

vice: NR 

• Oth

er De

vice: NR 

• Surgical: NR • Beha

vioral: NR

• Outcomes: 

• Anatomic/Physiologic: NR • Psychological: NR • Sexual Satisfaction: all pts 

used 100 mg sildenafi; (efficacy at 6-8

wks using a 

physician-administered questionnaire) (+) drug effect on duration & rigidityof erections in 12/29(41%); erections satisfactory for intercourse in 4/29(14%) 

• Patient logs/diaries: NR • Intervie

ws: NR 

• Foll

o

w-up: NR 

• A/

E

• Sys

(7%

SCI = spinal cord injury; AB = able-bodied; N

R = not reported; NA = not applicable; y = year; d = day; mo = month; 

wk =

week; hrs = hou

= control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; NS 

df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three times daily; b.i.d (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-126

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/ Eligibility

Criteria 

Intervention 

(e.g.,Pharmacologic/ 

Device/ 

Behavioural/Surgical/other) Outcomes/Follow-up

Events

Takeda, 

2000, 

Japan

(Ref ID 

3005) 

• Enrolled/ 

evaluated: n=36/NR 

• % males: 100%• Race/ethnicity:

NR 

• Age: 33.9 (18-

59) y

• Level of Injury: 

n=10 cervical; n=5 T1-6; n=12T7-12; n=9 lumbar lesions

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: (n=0) • Lost in followup: NR • N of sites: 1 • Funding: NR 

• Study Design:

Abstract from conference proceeding – interventional (time series before/after trial) 

• Duration: 3 mo 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment:

NA 

• Pharmacologic (n=36): • Drug name: sildenafil • Dose: NR • Duration: 3 mo• Schedule: NR • Mode/Admin. Route: oral• Device: NR • Other Device: NR 

• Surgical: NR • Behavioral: NR

• Outcomes: • Anatomic/Physiologic: 

IIEF5 score range 1-16 with mean of 5.8; drug assessed effective 22(56%); ineffective 5(13%); & unknown in 12pts (efficacy evaluation only in pts withsuccessful sexual intercourse followed 1 mo post dispensing the drug) 

• Psychological: NR • Sexual Satisfaction: NR • Patient logs/diaries: NR • Interviews: NR • Follow-up: NR

• A/E:• System

dysreflincludefacial fstrangl

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = significant; 

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function 
Appendix E. Evidence Tables (continued)

E-127

Evidence Table 6: Evidence from conference proceedings regarding sildenafil & other remediation for the treatment of sexual dindividuals after SCI (cont’d) 

Author, 

Year, 

Location 

Study

Characteristics 

Study Design & 

Duration/Quality

Assessment/Eligibility

Criteria 

Intervention 

(e.g.,Pharmacologic/Device/

Behavioural/Surgical/other) Outcomes/Follow-up

Com

Waldbaum, 

1998, 

US 

(Ref ID 

3004) 

• Enrolled/ 

evaluated: n=15/NR 

• % males: 100%• Race/ethnicity:

NR 

• Age: NR • Level of Injury: 

NR 

• ASIA Level: NR • Duration since 

injury: NR 

• Dropouts: n=0 • Lost in follow-up: 

NR 

• N of sites: 1 • Funding: NR 

• Study Design: Abstract 

from conference proceeding – interventional (time series before/after trial) 

• Duration: NR 

• Eligibility Criteria: • Inclusion: NR • Exclusion: NR • Quality Assessment: NA 

• Pharmacologic (n=15): • Drug name: MUSE/ 

prostaglandin E1 

• Dose: NR • Duration: NR • Schedule: NR • Mode/Admin. Route: 

intraurethral admin of MUSE; intracavernous injection of prostaglandineE1(alprostadil)

• Device: NR 

• Other Device: NR 

• Surgical: NR • Behavioural: NR 

• Outcomes: 

• Anatomic/Physiologic: 

4/15 achieved erection(grade?) with MUSE tx; 7/8/ remainder 11 pts achieved erection with prostaglandine E1 tx. 

• Psychological: NR • Sexual Satisfaction: NR • Patient logs/diaries: NR • Interviews: NR • Follow-up: NR

• A/E

SCI = spinal cord injury; AB = able-bodied; NR = not reported; NA = not applicable; y = year; d = day; mo = month; wk = week; hrs = houminute; ctrl = control(s); grp = group; pbo = placebo; mg = milligrams; μg = microgram; tx = treatment; hx = history; ∆ = change; S = sign

nonsignificant; df(s) = difference(s); pts = participants; n = n of participants; enrolled = n qualified; evaluated = n analyzed; t.i.d = three ti

b.i.d = two times daily; (+) = positive; A/E = adverse event; ED = erectile dysfunction; IIEF = Index of Erectile Function
Appendix E. Listing of Studies Included in Evidence Tables 

Listing of Studies Included in Evidence Tables 

Fertility

Bensman A, Kottke FJ. Induced emission of sperm utilizing 

electrical stimulation of the seminal vesicles and vas

deferens. Arch Phys Med Rehabil 1966;47(7):436-43. 

Beretta G, Chelo E, Zanollo A. Reproductive aspects in

spinal cord injured males. Paraplegia 1989;27(2):113-8. 

Beretta G, Zanollo A, Chelo E, Livi C, Scarselli G. Seminal

parameters and auto-immunity in paraplegic/quadraplegic 

men. Acta Eur Fertil 1987;18(3):203-5. 

Brackett NL, Abae M, Padron OF, Lynne CM. Treatment

by assisted conception of severe male factor infertility due 

to spinal cord injury or other neurologic impairment. J 

Assist Reprod Genet 1995;12(3):210-6. 

Brackett NL, Davi RC, Padron OF, Lynne CM. Seminal 

plasma of spinal cord injured men inhibits sperm motility 

of normal men. J Urol 1996;155(5):1632-5. 

Brackett NL, Lynne CM, Aballa TC, Ferrell SM. Sperm 

motility from the vas deferens of spinal cord injured men is 

higher than from the ejaculate. J Urol 2000;164(3 Pt 

1):712-5. 

Brackett NL, Lynne CM, Weizman MS, Bloch WE, Abae 

M. Endocrine profiles and semen quality of spinal cord 

injured men. J Urol 1994;151(1):114-9. 

Brackett NL, Lynne CM, Weizman MS, Bloch WE, Padron

OF. Scrotal and oral temperatures are not related to semen 

quality of serum gonadotropin levels in spinal cord-injured

men. J Androl 1994;15(6):614-9. 

Brackett NL, Padron OF, Lynne CM. Semen quality of

spinal cord injured men is better when obtained by

vibratory stimulation versus electroejaculation. J Urol 

1997;157(1):151-7. 

Brackett NL, Santa-Cruz C, Lynne CM. Sperm from spinal 

cord injured men lose motility faster than sperm from

normal men: the effect is exacerbated at body compared to

room temperature. J Urol 1997;157(6):2150-3. 

Brindley GS. Electroejaculation and the fertility of 

paraplegic men. Sex Disabil 1981;3(3):225-9. 

Brindley GS. The fertility of men with spinal injuries. 

Paraplegia 1984;22(6):337-48. 

Brindley GS. Electroejaculation: its technique, neurological 

implications and uses. J Neurol Neurosurg Psychiatry

1981;44(1):9-18. 

Brindley GS, Scott GI, Hendry WF. Vas cannulation with 

implanted sperm reservoirs for obstructive azoospermia or

ejaculatory failure. Br J Urol 1986;58(6):721-3. 

Brinsden PR, Avery SM, Marcus S, Macnamee MC. 

Transrectal electroejaculation combined with in-vitro 

fertilization: effective treatment of anejaculatory infertility 

due to spinal cord injury. Hum Reprod 1997;12(12):2687-

92. 

Buch JP, Zorn BH. Evaluation and treatment of infertility 

in spinal cord injured men through rectal probe 

electroejaculation. J Urol 1993;149(5 Pt 2):1350-4. 

Chapelle PA, Blanquart F, Puech AJ, Held JP. Treatment of 

anejaculation in the total paraplegic by subcutaneous 

injection of Physostigmine. Paraplegia 1983;21(1):30-6. 

Chen D, Hartwig DM, Roth EJ. Comparison of sperm 

quantity and quality in antegrade V retrograde ejaculates

obtained by vibratory penile stimulation in males with 

spinal cord injury. Am J Phys Med Rehabil 1997;78(1):46-

55. 

Chen D, Hartwig DM, Roth EJ. Comparison of sperm 

quantity and quality in antegrade V retrograde ejaculates

obtained by vibratory penile stimulation in males with 

spinal cord injury. Am J Phys Med Rehabil 1999;78(1):46-

51. 

Chung PH, Verkauf BS, Mola R, Skinner L, Eichberg RD, 

Maroulis GB. Correlation between semen parameters of

electroejaculates and achieving pregnancy by intrauterine 

insemination. Fertil Steril 1997;67(1):129-32. 

Dahlberg A, Ruutu M, Hovatta O. Pregnancy results from a 

vibrator application, electroejaculation, and a vas aspiration 

programme in spinal-cord injured men. Hum Reprod 

1995;10(9):2305-7. 

de Lamirande E, Leduc BE, Iwasaki A, Hassouna M, 

Gagnon C. Increased reactive oxygen species formation in

semen of patients with spinal cord injury. Fertil Steril

1995;63(3):637-42. 

Elliott SL, Griffin S, Ekland M, Nigro M. Vibrostimulation

- techniques and results. J Spinal Cord Med 

2000;23(3):175.

E-128
Appendix E. Listing of Studies Included in Evidence Tables (continued)

Elliott SL, Nigro M, Ekland MB, Griffin S, Allison G. The 

Vancouver experience: sperm retrieval program. J Spinal 

Cord Med 2002;25(Suppl1):s14. 

Halstead LS, VerVoort S, Seager SW. Rectal probe 

electrostimulation in the treatment of anejaculatory spinal

cord injured men. Paraplegia 1987;25(2):120-9. 

Hellstrom WJ, Stone AR, Deitch AD, deVere White RW. 

The clinical application of aspiration deoxyribonucleic acid 

flow cytometry to neurologically impaired men entering an

electroejaculation program. J Urol 1989;142(2 Pt 1):309-

12. 

Heruti RJ, Katz H, Menashe Y, Weissenberg R, Raviv G, 

Madjar I, et al. Treatment of male infertility due to spinal

cord injury using rectal probe electroejaculation: the Israeli 

experience. Spinal Cord 2001;39(3):168-75. 

Hirsch IH, McCue P, Allen J, Lee J, Staas WE. 

Quantitative testicular biopsy in spinal cord injured men:

comparison to fertile controls. J Urol 1991;146(2):337-41. 

Hirsch IH, Sedor J, Callahan HJ, Staas WE. Antisperm

antibodies in seminal plasma of spinal cord-injured men. 

Urology 1992;39(3):243-7. 

Hirsch IH, Sedor J, Kulp D, McCue PJ, Staas WE, Jr. 

Objective assessment of spermatogenesis in men with 

functional and anatomic obstruction of the genital tract. Int 

J Androl 1994;17(1):29-34. 

Hou JW, Chen D, Jeyendran RS. Sperm nuclear maturity in 

spinal cord-injured men: evaluation by acidic aniline blue 

stain. Arch Phys Med Rehabil 1995;76(5):444-5. 

Hultling C, Levi R, Garoff L, Nylund L, Rosenborg L, 

Sjoblom P, et al. Assisted ejaculation combined with in

vitro fertilisation: an effective technique treating male 

infertility due to spinal cord injury. Paraplegia 

1994;32(7):463-7. 

Hultling C, Rosenlund B, Levi R, Fridstrom M, Sjoblom P, 

Hillensjo T. Assisted ejaculation and in-vitro fertilization in 

the treatment of infertile spinal cord-injured men: the role

of intracytoplasmic sperm injection. Hum Reprod

1997;12(3):499-502. 

Kolettis PN, Lambert MC, Hammond KR, Kretzer PA, 

Steinkampf MP, Lloyd LK. Fertility outcomes after 

electroejaculation in men with spinal cord injury. Fertil

Steril 2002;78(2):429-31. 

Le Chapelain L, Nguyen VT, Dehail P, Berjon JJ, Barat M,

Mazaux JM, et al. Ejaculatory stimulation, quality of semen 

and reproductive aspects in spinal cord injured men. Spinal 

Cord 1998;36(2):132-6. 

Leduc BE, Roy D, Poulin O. The use of physostigmine in 

men with spinal cord injury with ejaculatory dysfunction.

Can J Rehab 1992;5(4):231-5. 

Lim TC, Mallidis C, Hill ST, Skinner DJ, Carter PD, 

Brown DJ, et al. A simple technique to prevent retrograde 

ejaculation during assisted ejaculation. Paraplegia

1994;32(3):142-9. 

Loecher-Ernst D, Grosse J, Mandalka B, Kramer G, Stohrer

M. Semen retrieved and fertility in 229 spinal cord injured 

males:longterm results of a fertility program in spinal cord 

injured males. J Spinal Cord Med 1998;21(2):164. 

Lucas MG, Hargreave TB, Edmond P, Creasey GH, 

McParland M, Seager SW. Sperm retrieval by electroejaculation. Preliminary experience in patients with 

secondary anejaculation. Br J Urol 1991;67(2):191-4. 

Mallidis C, Lim TC, Hill ST, Skinner DJ, Brown DJ, 

Johnston WI, et al. Necrospermia and chronic spinal cord 

injury. Fertil Steril 2000;74(2):221-7. 

Mallidis C, Lim TC, Hill ST, Skinner DJ, Brown DJ, 

Johnston WI, et al. Collection of semen from men in acute 

phase of spinal cord injury. Lancet 1994;343(8905):1072-3. 

Martin DE, Warner H, Crenshaw TL, Crenshaw RT, 

Shapiro CE, Perkash I. Initiation of erection and semen 

release by rectal probe electrostimulation (RPE). J Urol 

1983;129(3):637-42. 

Matthews GJ, Gardner TA, Eid JF. In vitro fertilization 

improves pregnancy rates for sperm obtained by rectal 

probe ejaculation. J Urol 1996;155(6):1934-7. 

Monga M, Dunn K, Rajasekaran M. Characterization of 

ultrastructural and metabolic abnormalities in semen from

men with spinal cord injury. J Spinal Cord Med

2001;24(1):41-6. 

Nehra A, Werner MA, Bastuba M, Title C, Oates RD. 

Vibratory stimulation and rectal probe electroejaculation as 

therapy for patients with spinal cord injury: semen 

parameters and pregnancy rates. J Urol 1996;155(2):554-9. 

Odum L, Sonksen J, Biering-Sorensen F. Seminal 

somatostatin in men with spinal cord injury. Paraplegia

1995;33(7):374-6. 

Ohl DA, Bennett CJ, McCabe M, Menge AC, McGuire EJ.

Predictors of success in electroejaculation of spinal cord 

injured men. J Urol 1989;142(6):1483-6. 

Ohl DA, Denil J, Fitzgerald-Shelton K, McCabe M, 

McGuire EJ, Menge AC, et al. Fertility of spinal cord 

injured males: effect of genitourinary infection and bladder 

management on results of electroejaculation. J Am

Paraplegia Soc 1992;15(2):53-9. 

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Appendix E. Listing of Studies Included in Evidence Tables (continued)

Ohl DA, Sonksen J, Menge AC, McCabe M, Keller LM. 

Electroejaculation versus vibratory stimulation in spinal 

cord injured men: sperm quality and patient preference. J 

Urol 1997;157(6):2147-9. 

Padron OF, Brackett NL, Weizman MS, Lynne CM. Semen 

of spinal cord injured men freezes reliably. J Androl 

1994;15(3):266-9. 

Park CI, Shin J, Kim D, Cho S. Ejaculatory induction and

semen analysis with vibratory and electrical stimulation in

spinal cord injured patients. Arch Phys Med Rehabil 

1999;80:1195. 

Perkash I, Martin DE, Warner H, Blank MS, Collins DC. 

Reproductive biology of paraplegics: results of semen 

collection, testicular biopsy and serum hormone evaluation. 

J Urol 1985;134(2):284-8. 

Pryor JL, Kuneck PH, Blatz SM, Thorp C, Cornwell CE,

Carrell DT. Delayed timing of intrauterine insemination 

results in a significantly improved pregnancy rate in female 

partners of quadriplegic men. Fertil Steril 2001;76(6):1130-

5. 

Pryor JL, LeRoy SC, Nagel TC, Hensleigh HC. Vibratory

stimulation for treatment of anejaculation in quadriplegic 

men. Arch Phys Med Rehabil 1995;76(1):59-64. 

Rawicki HB, Hill S. Semen retrieval in spinal cord injured 

men. Paraplegia 1991;29(7):443-6. 

Rutkowski SB, Middleton JW, Truman G, Hagen DL, Ryan 

JP. The influence of bladder management on fertility in 

spinal cord injured males. Paraplegia 1995;33(5):263-6. 

Sarkarati M, Rossier AB, Fam BA. Experience in vibratory 

and electro-ejaculation techniques in spinal cord injury

patients: a preliminary report. J Urol 1987;138(1):59-62. 

Seager SWJ, Halstead LS. Electroejaculation - techniques

and results. J Spinal Cord Med 2000;23(3):174. 

Siosteen A, Forssman L, Steen Y, Sullivan L, Wickstrom I. 

Quality of semen after repeated ejaculation treatment in 

spinal cord injury men. Paraplegia 1990;28(2):96-104. 

Sonksen J, Biering-Sorensen F, Kristensen JK. Ejaculation 

induced by penile vibratory stimulation in men with spinal 

cord injuries. The importance of the vibratory amplitude. 

Paraplegia 1994;32(10):651-60. 

Sonksen J, Sommer P, Biering-Sorensen F, Ziebe S, 

Lindhard A, Loft A, et al. Pregnancy after assisted 

ejaculation procedures in men with spinal cord injury. Arch 

Phys Med Rehabil 1997;78(10):1059-61. 

Taylor Z, Molloy D, Hill V, Harrison K. Contribution of

the assisted reproductive technologies to fertility in males 

suffering spinal cord injury. Aust N Z J Obstet Gynaecol 

1999;39(1):84-7. 

VerVoort SM, Donovan WH, Dykstra DD, Syers P. 

Increased current delivery and sperm collection using 

nifedipine during electroejaculation in men with high spinal 

cord injuries. Arch Phys Med Rehabil 1988;69(8):595-7. 

Wang YH, Chiang HS, Wu CH, Lien IN. Electroejaculation

in spinal cord injured males. J Formos Med Assoc

1992;91(4):413-8. 

Warner H, Martin DE, Perkash I, Speck V, Nathan B. 

Electrostimulation of erection and ejaculation and 

collection of semen in spinal cord injured humans. J 

Rehabil Res Dev 1986;23(3):21-31. 

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Appendix E. Listing of Studies Included in Evidence Tables (continued)

Sexual Dysfunction

Beretta G, Saltarelli O, Marzotto M, Zanollo A, Re B.

Transcutaneous minoxidil in the treatment of erectile 

dysfunctions in spinal cord injured men. Acta Eur Fertil

1993;24(1):27-30. 

Beretta G, Zanollo A, Fanciullacci F, Catanzaro F. 

Intracavernous injection of papaverine in paraplegic 

males. Acta Eur Fertil 1986;17(4):283-4. 

Bodner DR, Haas CA, Krueger B, Seftel AD. 

Intraurethral alprostadil for treatment of erectile 

dysfunction in patients with spinal cord injury. Urology

1999;53(1):199-202. 

Bodner DR, Seftel A, Krueger B. Intraurethral 

Alprostsdil (MUSE) for treatment of erectile dysfunction

in spinal cord injured patients. J Spinal Cord Med

1998;21(2):186-7. 

Chancellor MB, Rivas DA, Panzer DE, Freedman MK, 

Staas WE, Jr. Prospective comparison of topical 

minoxidil to vacuum constriction device and

intracorporeal papaverine injection in treatment of

erectile dysfunction due to spinal cord injury. Urology

1994;43(3):365-9. 

Chapelle PA, Roby-Brami A, Yakovleff A, Bussel B. 

Neurological correlations of ejaculation and testicular

size in men with a complete spinal cord section. J Neurol 

Neurosurg Psychiatry 1988;51(2):197-202. 

Clontz D, Kier A, Land D, Hudson B, Kennelly M. 

Effects of sildenafil on spinal cord injury patients 

suffering from erectile dysfunction. J Spinal Cord Med

1999;22(1):48-9. 

Costa P, Bressolle F, Sarrazin B, Mosser J, Navratil H, 

Galtier M. Moxisylyte plasma kinetics in humans after 

intracavernous administration. Biopharm Drug Dispos

1992;13(9):671-9. 

Costa P, Sarrazin B, Bressolle F, Mottet N, Louis JF,

Saudubray F, et al. Is the volume injected a parameter 

likely to influence the erectile response observed after 

intracavernous administration of an alpha-blocking 

agent? Eur Urol 1993;24(1):43-7. 

Courtois F, Mathieu C, Charvier K. Sexual rehabilitation

for men with spinal cord injury: Preliminary report on a 

behavioral strategy. Sex Disabil 2001;19(2):153-7. 

Derry FA, Dinsmore WW, Fraser M, Gardner BP, Glass

CA, Maytom MC, et al. Efficacy and safety of oral 

sildenafil (Viagra) in men with erectile dysfunction 

caused by spinal cord injury. Neurology

1998;51(6):1629-33. 

Earle CM, Keogh EJ, Ker JK, Cherry DJ, Tulloch AG,

Lord DJ. The role of intracavernosal vasoactive agents to

overcome impotence due to spinal cord injury.

Paraplegia 1992;30(4):273-6. 

Gans WH, Zaslau S, Wheeler S, Galea G, Vapnek JM.

Efficacy and safety of oral sildenafil in men with erectile 

dysfunction and spinal cord injury. J Spinal Cord Med

2001;24(1):35-40. 

Giuliano F, Hultling C, El Masry WS, Luchner E, Stien

R, Maytom MC, et al. Sildenafil citrate (VIAGRA): a 

novel oral treatment for erectile dysfunction caused by

traumatic spinal cord injury. Int J Clin Pract

1999;Supplement. 102:24-6. 

Giuliano F, Hultling C, El Masry WS, Smith MD, 

Osterloh IH, Orr M, et al. Randomized trial of sildenafil

for the treatment of erectile dysfunction in spinal cord 

injury. Sildenafil Study Group. Ann Neurol

1999;46(1):15-21. 

Golji H. Experience with penile prosthesis in spinal cord 

injury patients. J Urol 1979;121(3):288-9. 

Green BG, Sloan SL. Penile prostheses in spinal cord 

injured patients: combined psychosexual counselling and

surgical regimen. Paraplegia 1986;24(3):167-72. 

Gross AJ, Sauerwein DH, Kutzenberger J, Ringert RH. 

Penile prostheses in paraplegic men. Br J Urol

1996;78(2):262-4. 

Heller L, Keren O, Aloni R, Davidoff G. An open trial of

vacuum penile tumescence: constriction therapy for 

neurological impotence. Paraplegia 1992;30(8):550-3. 

Hirsch IH, Smith RL, Chancellor MB, Bagley DH, 

Carsello J, Staas WE, Jr. Use of intracavernous injection 

of prostaglandin E1 for neuropathic erectile dysfunction.

Paraplegia 1994;32(10):661-4. 

Hultling C. Partners' perceptions of the efficacy of

sildenafil citrate (VIAGRA) in the treatment of erectile

dysfunction. Int J Clin Pract 1999;Supplement. 102:16-

8. 

Hultling C, Giuliano F, Quirk F, Pena B, Mishra A, 

Smith MD. Quality of life in patients with spinal cord 

injury receiving Viagra (sildenafil citrate) for the

treatment of erectile dysfunction. Spinal Cord

2000;38(6):363-70. 

Iwatsubo E, Tanaka M, Takahashi K, Akatsu T. Noninflatable penile prosthesis for the management of

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Appendix E. Listing of Studies Included in Evidence Tables (continued)

urinary incontinence and sexual disability of patients 

with spinal cord injury. Paraplegia 1986;24(5):307-10. 

Jaworski TM, Richards JS, Lloyd LK. Retrospective

review of sexual and marital satisfaction of spinal cord 

injury and diabetic males post penile injection or

implant. Urology 1992;40(2):127-31. 

Kapoor VK, Chahal AS, Jyoti SP, Mundkur YJ, Kotwal 

SV, Mehta VK. Intracavernous papaverine for impotence 

in spinal cord injured patients. Paraplegia

1993;31(10):675-7. 

Kier AJ, Kennelly MJ, Holdren RE, Land DG, Hudson 

BS, Clontz DR. Sildenafil effects on spinal cord patients

with erectile dysfunction. 16th American association of 

spinal cord injury nurses conference 1999;32-3. 

Kim ED, McVary KT. Topical prostaglandin-E1 for the 

treatment of erectile dysfunction. [see comments.]. J 

Urol 1995;153(6):1828-30. 

Kim ED, el Rashidy R, McVary KT. Papaverine topical 

gel for treatment of erectile dysfunction. J Urol

1995;153(2):361-5. 

Komisaruk BR, Gerdes CA, Whipple B. 'Complete' 

spinal cord injury does not block perceptual responses to 

genital self-stimulation in women. Arch Neurol

1997;54(12):1513-20. 

Laschke S, Carl S, Staehler G, Gerner HJ. Efficacy and 

reproducibility of sildenafil (Viagra) in erectile 

dysfunction in spinal cord injured men. J Spinal Cord 

Med 2002;25(Suppl1):s43. 

Martin DE, Warner H, Crenshaw TL, Crenshaw RT, 

Shapiro CE, Perkash I. Initiation of erection and semen 

release by rectal probe electrostimulation (RPE). J Urol

1983;129(3):637-42. 

Maytom MC, Derry FA, Dinsmore WW, Glass CA,

Smith MD, Orr M, et al. A two-part pilot study of

sildenafil (VIAGRA) in men with erectile dysfunction 

caused by spinal cord injury. Spinal Cord

1999;37(2):110-6. 

Montague DK. Penile prosthesis implantation in men 

with neurogenic impotence. Sex Disabil 1994;12(1):94-

8. 

Sildenafil in men with spinal cord injury. Nurses Drug 

Alert 1999;23(2):12. 

Potter PJ, Hayes KC, Segal JL, Hsieh JT, Brunnemann 

SR, Delaney GA, et al. Randomized double-blind

crossover trial of fampridine-SR (sustained release 4-

aminopyridine) in patients with incomplete spinal cord 

injury. J Neurotrauma 1998;15(10):837-49. 

Raviv G, Heruti RJ, Shaked A, Katz H, Ohry A, Ramon 

J, et al. Sexual rehabilitation: clinical experience with 

sildenafil citrate (Viagra) in spinal cord injured patients.

Int J Impot Res 2000;12(Suppl 5):s1. 

Renganathan R, Suranjan B, Kurien T. Comparison of 

transdermal nitroglycerin and intracavernous injection of 

papaverine in the treatment of erectile dysfunction in 

patients with spinal cord lesions. Spinal Cord

1997;35(2):99-103. 

Richards JS. Treatment of erectile dysfunction secondary

to spinal cord injury: Sexual and psychosocial impact on 

couples. Rehabil Psych 1993;37(3):211-3. 

Sanchez RA, Vidal J, Jauregui ML, Barrera M, Recio C,

Giner M, et al. Efficacy, safety and predictive factors of 

therapeutic success with sildenafil for erectile

dysfunction in patients with different spinal cord injuries.

Spinal Cord 2001;39(12):637-43. 

Schmid DM, Schurch B, Hauri D. Sildenafil in the 

treatment of sexual dysfunction in spinal cord-injured 

male patients. Eur Urol 2000;38(2):184-93. 

Shenot PJ, Rajan R, Rivas DA. Initial experience with 

sildenafil (viagra) in spinal cord injured men with 

erectile dysfunction. J Spinal Cord Med 1999;22(1):49. 

Sidi AA, Cameron JS, Dykstra DD, Reinberg Y, Lange 

PH. Vasoactive intracavernous pharmacotherapy for the 

treatment of erectile impotence in men with spinal cord 

injury. J Urol 1987;138(3):539-42. 

Sipski ML, Alexander CJ, Rosen R. Sexual arousal and

orgasm in women: effects of spinal cord injury. Ann 

Neurol 2001;49(1):35-44. 

Sipski ML, Alexander CJ, Rosen RC. Physiological 

parameters associated with psychogenic sexual arousal in

women with complete spinal cord injuries. Arch Phys 

Med Rehabil 1995;76(9):811-8. 

Sipski ML, Alexander CJ, Rosen RC. Orgasm in women 

with spinal cord injuries: a laboratory-based assessment. 

Arch Phys Med Rehabil 1995;76(12):1097-102. 

Sipski ML, Rosen RC, Alexander CJ, Hamer RM. 

Sildenafil effects on sexual and cardiovascular responses 

in women with spinal cord injury. Urology

2000;55(6):812-5. 

Sipski ML, Rosen RC, Alexander CJ. Physiological 

parameters associated with the performance of a

distracting task and genital self-stimulation in women 

with complete spinal cord injuries. Arch Phys Med 

Rehabil 1996;77(5):419-24. 

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Appendix E. Listing of Studies Included in Evidence Tables (continued)

Sonksen J, Biering-Sorensen F. Transcutaneous 

nitroglycerin in the treatment of erectile dysfunction in 

spinal cord injured. Paraplegia 1992;30(8):554-7. 

Takeda H, Otani T, Ito Y. Efficacy of sildenafil citrate 

for ED associated with spinal cord injury. Int J Impot 

Res 2000;12(Sup 2):s19. 

Tang SF, Chu NK, Wong MK. Intracavernous injection 

of prostaglandin E1 in spinal cord injured patients with 

erectile dysfunction. A preliminary report. Paraplegia

1995;33(12):731-3. 

van der Aa HE, Alleman E, Nene A, Snoek G. Sacral 

anterior root stimulation for bladder control: clinical 

results. Arch Physiol Biochem 1999;107(3):248-56. 

van der Aa HE, Hermens H, Alleman E, Vorsteveld H.

Sacral anterior root stimulation for bladder control in

patients with a complete lesion of the spinal cord. Acta 

Neurochir (Wien) 1995;134(1-2):88-92. 

Waldbaum J, Chen D, Nussbaum SB, Hartwig DM. Use 

of transurethral alprostadil to treat erectile dysfunction in 

spinal cord injured patients. Arch Phys Med Rehabil

1998;79:1184. 

Whipple B. Sexual responses to self-stimulation in 

women with complete spinal cord injury. J Sex Res

1996;33(3):231-40. 

Zaslau S, Nicolis C, Galea G, Britanico J, Vapnek JM. A 

simplified pharmacologic erection program for patients 

with spinal cord injury. J Spinal Cord Med

1999;22(4):303-7. 

Zasler ND, Katz PG. Synergist erection system in the

management of impotence secondary to spinal cord 

injury. Arch Phys Med Rehabil 1989;70(9):712-6. 

E-133
Appendix F. Additional Acknowledgments 

Appendix F. Additional Acknowledgments 

The UO-EPC gratefully acknowledges the following individuals who served on our 

Technical Expert Panel (TEP). Acknowledgment does not reflect endorsement of this 

report. 

David Chen, MD 

Assistant Professor of Physical Medicine and 

Rehabilitation, 

Department of Physical Medicine and 

Rehabilitation, 

Northwestern University Medical School; & 

Spinal Cord Injury Program, 

Rehabilitation Institute of Chicago, 

Chicago, IL

Stanley H. Ducharme, PhD 

Senior Consultant, Private Practice in 

Clinical/Health Psychology, 

Boston University Medical Center, 

Boston, MA 

Stacy L. Elliott, MD 

Clinical Professor, Department of Psychiatry; 

Associate Member, Division of Urology, 

Department of Surgery, Faculty of Medicine 

University of British Columbia

Vancouver, BC 

Arthur Leader, MD 

Professor of Obstetrics, Gynaecology & 

Medicine Chief, Division of Reproductive 

Medicine

University of Ottawa 

Ottawa, ON 

Todd A. Linsenmeyer, MD 

Director of Urology

Kessler Institute for Rehabilitation; 

Associate Professor, Physical Medicine and 

Rehabilitation & 

Surgery (Division of Urology) 

UMDNJ-New Jersey Medical School, 

Newark, NJ 

Shawn Marshall, MD 

Assistant Professor, 

Department of Medicine, 

University of Ottawa 

Ottawa, ON 

F-134
Appendix F. Additional Acknowledgments (continued) 

The UO-EPC gratefully acknowledges the following individuals who reviewed the initial 

draft of this evidence report, and provided constructive feedback. Acknowledgement does 

not reflect endorsement of this report. 

David Atkins, MD, MPH 

Chief Medical Officer 

Center for Outcomes and Evidence 

Agency for Healthcare Research Quality

Rockville, MD 

Nancy Brackett, PhD, HCLD 

Research Assistant Professor of 

Neurological Surgery & Urology

University of Miami School of Medicine 

Miami, FL 

Gerald Brock, MD, FRCS 

Associate Professor, 

Department of Surgery, Division of Urology

St. Joseph’s Health Centre

London, ON 

Anthony S. Burns, MD 

Assistant Professor 

Department of Rehabilitation Medicine 

Thomas Jefferson University

Philadelphia, PA 

Peter N. Kolettis, MD 

Associate Professor, Division of Urology

The University of Alabama (Birmingham) 

Birmingham, AL 

F-135