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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AHRQ Pub. No. 05-E003-1

December 2004

ISSN 1530-440X