Clinical trial NCT03801031
Conditions: Gynecologic Cancer Sexual Dysfunction
Sponsor: David Bender
Start date: 2019-06-06; Completion date: 2021-11-03
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will evaluate sexual dysfunction in women who have had surgery for gynecologic cancer. The subjects will complete a set of questionnaires about health, daily living, sexual encounters, and pain before their surgery and three times following. Each subject will be randomized to receive either lidocaine or a placebo that is applied vaginally immediately prior to any sexual encounters for approximately 6 months while maintaining a journal of sexual encounters and pain. The subjects and healthcare providers will be blinded to the treatment randomization until intervention and data collection is complete. Total participation will last up to one year from the date of enrollment. Subjects will visit the clinic at the same time as regular cancer care visits, receive the blinded intervention and complete the surveys.

Detailed description:
Once consented, subjects will complete nine short surveys (The Female Sexual Function Index, The PHQ-9, the GAD-7, the Social Provision Score (SPS), Rosenberg's Body Self-Esteem Index, the Severity of Posttraumatic Stress (PTS) Symptoms Scale, the Adverse Childhood Events Index, the Short Form (SF)-12, and the Dyadic Adjustment Scale) at their initial visit, assessing physical, psychological, and social elements related to sexuality.

Subjects will then have the tumor reduction surgery.

Twelve weeks after her surgery, each subject will be asked to complete the same nine-survey packet.

Once the second packet is completed, subjects will be randomized to receive either aqueous lidocaine (4%) or placebo with instructions to apply the solution to three cotton balls and place them on the perineum/vaginal introitus for one minute prior to sexual intercourse. Subjects will be educated on the use of this blinded intervention and be asked to keep a diary of sexual encounters, including a simple pictorial pain scale for each encounter. Subjects and providers are blinded to the assigned intervention.

Once subjects complete three months of perineal intervention, they will be asked at a follow-up visit (12 weeks following randomization) to complete the survey packet for a third time.

Subjects will then continue their perineal intervention, keep a diary of sexual encounters with the pain scale and return after another three-month interval for a fourth completion of the survey packet. Sexual encounter diaries and pain scale assessments will be collected and their participation in the trial will conclude. Also at the time of this concluding follow-up visit in the Gynecologic Oncology Clinic, patients will receive counseling by a gynecologic oncologist regarding education about sexual dysfunction, the possibility of experiencing sexual dysfunction, and a potential referral for further treatment of sexual dysfunction. The subject will remain blinded to the randomized intervention until the conclusion of the study.

Subjects will be unblinded and informed of assigned intervention at the conclusion of the study via a letter sent to their home address from the researchers.

Arms: arm 1: Patients being treated for gynecologic cancer assigned aqueous lidocaine solution as intervention to use during sexual encounters. arm 2: Patients being treated for gynecologic cancer assigned placebo solution as intervention to use during sexual encounters.
Interventions: intervention 1: Lidocaine Topical intervention 2: Placebo
Intervention descriptions: intervention 1: Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention. intervention 2: Placebo solution intervention used to validate the effects of the lidocaine solution usage.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
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Version #: 5  
 
 
Version Date: January 2, 2019 
 
 
Title: Sexual Dysfunction in Gynecologic Oncology Patients 
 
Principle Investigator: 
David P. Bender, M.D. 
31506 PFP 
200 Hawkins Drive 
University of Iowa Hospitals and Clinics 
Iowa City, IA 52242 
319-356-2015 
319-252-8363 
david-bender@uiowa.edu 
 
Co-Principal Investigator:  
 
Not applicable 
Sub-Investigators:  
 
Michael Goodheart, M.D. 
Jesus Gonzalez-Bosquet, M.D. 
Jean-Marie Stephan, M.D. 
Emily K. Hill, M.D. 
Veronika Kolder, M.D. 
Biostatistician: 
Gideon K.D. Zamba, M.S., Ph.D. 
Primary Research Coordinator: 
Sharon Stockman 
IRB Number: 
201609770 
Version Date: 
01/02/2019 
Version: 
5 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
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SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients undergoing surgery at UIHC for suspected or diagnosed  
ovarian, fallopian tube, peritoneal, cervical or endometrial cancer 
Consent for study and complete survey packet evaluating sexual dysfunction 
Eligible subjects with a diagnosis of a gynecologic cancer will continue on trial 
12 weeks following primary surgery repeat survey packet evaluating sexual dysfunction 
Randomization 
4% Aqueous lidocaine application                                             Placebo application 
12 weeks after treatment, repeat survey packet and submit 
Visual pain scales and sexual encounter diary 
24 weeks after randomization, repeat survey packet and submit 
Visual pain scales and sexual encounter diary 


 
 
 
 
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Version #: 5  
 
 
Version Date: January 2, 2019 
 
REVISION HISTORY 
 
 
Version 1, Version Date November 28, 2016 
 
Version 2, Version Date February 20, 2017 
 
Version 3, Version Date March 24, 2017 
 
Summary of Changes:  
 
1. Version number and date updated 
 
2. Questionnaire revisions: 
 
 
a. Adverse Childhood Experiences questionnaire replaced by accurate  
 
 
 
version. Previously included the International version, which is not  
 
 
 
intended to use.  
 
 
b. Revised Subject Diary with pain scale and sexual encounter log 
 
 
c. Revised Exit Questionnaire – The term “gel” replaced with “solution”  
 
 
    and questions added 
 
Version 4, Version Date May 23, 2017 
 
Summary of Changes: The primary purpose of this amendment is to clarify the 
unblinding procedure.  (Section 5.2.2) 
 
Version 5, Version Date January 2, 2019 
 
Corrected description SPS as Social Provisions Scale (Section 5.2.3) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
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TABLE OF CONTENTS 
 
 
Schema .......................................................................................................................... 2 
 
1. ABSTRACT ............................................................................................................... 5 
 
2. BACKGROUND/RATIONALE ................................................................................... 5 
 
3. STUDY GOALS/OBJECTIVES ................................................................................. 6 
 
4. Study Population ..................................................................................................... 6 
   4.1 Inclusion Criteria ................................................................................................. 6 
   4.2 Exclusion Criteria ................................................................................................ 7 
 
5.   STUDY DESIGN AND METHODS ............................................................................ 7 
 
6.   STUDY PROCEDURES……………………………………………………………………9 
 
Schedule of Events Table  ................................................................................... 10 
 
7. SAFETY  .................................................................................................................. 11 
 
8. STATISTICAL EVALUATION/CONSIDERATIONS  ............................................... 11 
 
9. DATA COLLECTION AND RECORD KEEPING .................................................... 12 
 
10. REFERENCES ........................................................................................................ 12 
 
11.  APPENDICES 
       Appendix I: Patient Data Collection Instruments/ Surveys 
 
Appendix II: HCCC Data Safety and Monitoring Plan 
 
 
 
 
 


 
 
 
 
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1. Abstract 
Sexual dysfunction is known to affect women newly diagnosed with cancer.  This 
project will evaluate critical elements contributing to sexual dysfunction in women 
who have had surgery for gynecologic cancer and potentially provide a simple, 
easily applicable, and meaningful intervention. The subjects will complete a set of 
questionnaires about health, daily living, sexual activity, and pain before their 
surgery and three times following interventions. Each subject will be randomized to 
receive a perineal application of either lidocaine or a placebo to use immediately 
prior to any sexual encounters for approximately 6 months while maintaining a 
journal of sexual encounters and pain. The subjects and healthcare providers will be 
blinded to the treatment. Total participation will last approximately one year from the 
date of enrollment.  We aim to better characterize elements related to sexual 
dysfunction in this specific population, and provide a treatment intervention to 
improve patient’s quality of life, measured by changes in their physical, 
psychological or social functioning.  
 
2. Background / Rationale 
Sexual dysfunction in gynecologic cancer survivors has been well-documented [1].  
Physical, psychological and social elements contribute to sexual dysfunction in this 
population.  In 2011, over 88,000 women in the United States were diagnosed with 
gynecologic cancers. The majority of these cases affected women over the age of 
60 [2]. Treatment of these cancers, while aimed at preventing death, may cause 
significant changes in physical, psychological or social functioning. These changes 
could lead to negative long-term effects on women’s sexuality. It is important to 
recognize the multifactorial nature of this problem. While research exists regarding 
this topic, few studies include all three domains of sexual functioning. Even fewer 
studies are aimed at designing a specific intervention to address any aspect of the 
dysfunction [1]. One previous study from 1989 at the University of Iowa detailed the 
physical side effects of gynecologic cancer, showing that cancer survivors 
experienced decreased sexual activity, decreased sexual desire, decreased sexual 
excitement, less awareness of signs of orgasm, and dyspareunia compared to 
control groups [3]. In an additional study in the same year by the same group, the 
psychological effects of treatment are detailed. However, these outcomes were not 
directly related to feelings regarding sexual activity or the psychological effects of 
changes in sexuality and were not aimed at interventions [4]. In a study of breast 
cancer survivors, suffering from dyspareunia, Goetsch, et. al., described the use of 
4% lidocaine jelly applied for 3 minutes to areas of pain on a cotton ball. This study 
found that this preparation reduced pain on exam and insertion when compared to 
saline placebo [5]. Lack of a full understanding of physical sexual dysfunction 
following a diagnosis and treatment of gynecologic cancer has been a detriment to 
developing interventions aimed at these issues.   
 


 
 
 
 
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3. Study Goals/Objectives 
 
 
• The primary objective is to identify changes in sexual function assessments 
(Female Sexual Function Index survey, frequency of sexual encounters and a 
visual pain scale assessment with each encounter) after application of an 
aqueous lidocaine solution to the perineum versus a placebo application.   
o Hypothesis: Subjects surgically treated for ovarian, peritoneal, fallopian 
tube, cervical or endometrial cancer will have higher sexual functioning 
and less pain associated with sexual encounters after perineal 
treatment with aqueous lidocaine.    
• 
 Secondary objectives include characterizing the pre and post-treatment 
functioning of gynecologic cancer survivors with respect to physical, 
psychological, and social dimensions. 
o Subjects will complete nine short surveys (The Female Sexual 
Function Index, The PHQ-9, the GAD-7, the SPS, Rosenberg’s Body 
Self-Esteem Index, the Severity of PTS Symptoms Scale, the Adverse 
Childhood Events Index, the SF-12, and the Dyadic Adjustment Scale) 
at their initial visit, assessing physical, psychological, and social 
elements related to sexuality.  The same packet of surveys will be 
completed twelve weeks following surgery, after which, they will be 
randomized to a blinded perineal intervention.  Survey packets will be 
completed 12 and 24 weeks following randomization to the perineal 
intervention. 
o A visual pain scale will be completed after each sexual encounter. 
o A diary documenting frequency of sexual encounters will be collected.  
 
 
 
 
 
4. Study Population 
Subjects comprising this study population include women undergoing initial 
consultation at the University of Iowa Hospitals and Clinics/Holden Comprehensive 
Cancer Center for a documented or suspected diagnosis of ovarian, fallopian tube, 
peritoneal, endometrial or cervical cancer.  Each subject must be scheduled to 
undergo surgical treatment for their disease prior to enrollment.  Enrollment will be 
offered and consent obtained by the Investigator or one of the sub-Investigators at 
the time of initial consultation in the outpatient clinic.   
 
Subjects ultimately diagnosed with one of the previously mentioned gynecologic 
malignancies will remain eligible to continue on the trial, while those found to have 
no evidence of cancer will be excluded.   
 
Inclusion/Exclusion Criteria:  
 
4.1 Inclusion criteria  
• Female 
• Age 18-99 


 
 
 
 
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• Planned to undergo primary surgical treatment at the University of Iowa Hospitals 
and Clinics for a suspected or proven diagnosis of ovarian, fallopian tube, 
peritoneal, endometrial, or cervical cancer 
• Able to give informed consent and follow study procedures 
• No previous reactions to lidocaine applications 
• GOG Performance Status of 0 or 1   
• Reports having engaged in vaginal intercourse at least once in the last 12 
months 
 
 
 
4.2 Exclusion criteria:  
• Failure to confirm invasive ovarian, fallopian tube, peritoneal, endometrial or 
cervical cancer by pathology from primary biopsy or surgery (subjects will not be 
eligible to continue the trial beyond the initial completion of the questionnaires) 
• Diagnosis of another malignancy within the past five years, excluding basal cell 
carcinoma of the skin 
• Patients undergoing primary or adjuvant external pelvic radiation (excluding 
adjuvant vaginal brachytherapy) 
• Previous reactions to lidocaine applications 
• Sexual partners’ previous reactions to lidocaine applications 
  
 
 
 
5. Study Design and Methods 
 
5.1 Data Acquisition 
 
Study data will primarily be obtained through questionnaires and self-reported data 
from a visual pain scale and a diary documenting frequency of sexual encounters.   
 
5.1.1:  The questionnaire packet consists of nine short surveys that capture 
 
information on psychological, social and physical elements previously cited as  
 
 
potential influences on sexual dysfunction.  This survey packet will be completed   
 
prior to a surgical intervention with the intent to capture a “baseline” for the  
 
 
subject.  Completion of the survey packet will be requested at the three month  
 
 
postoperative check-up visit and then at two more sequential three month follow-  
 
up visits.  The perineal intervention will be introduced at the first three month  
 
 
postoperative visit. 
 
 
 
5.1.2:  Subjects will self-report potential discomfort related to each sexual 
 
encounter on a visual pain scale.  These scales will be collected at each three  
 
 
month follow-up visit. 
 
 
5.1.3:  Subjects will be asked to maintain a diary/calendar documenting the 
  
frequency of  sexual encounters and the successful or unsuccessful ability to  
 


 
 
 
 
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apply the perineal intervention.  The diary/calendar will be collected at each three 
 
month visit. 
 
5.2 Procedures 
 
5.2.1: Primary surgical intervention 
Subjects will be eligible and plan to undergo a primary surgical procedure  for the 
treatment of their gynecologic cancer (ovarian, fallopian tube, peritoneal, 
endometrial or cervical) under one of the UIHC gynecologic oncologists.  Surgical 
treatment of these cancers, which includes removing some or all of the 
gynecologic organs, may cause physical as well as perceived changes in sexual 
function.  Surgical treatment for ovarian, fallopian tube, peritoneal, endometrial, 
and early stage cervical cancers is often the first option of treatment for 
appropriately selected patients and critical to a comprehensive treatment 
approach.  It is the goal to systematically evaluate the changes in sexual function 
prior to and following primary surgery for these subjects.  
 
5.2.2 Randomization 
Patients will be randomized to receive either the lidocaine solution or a placebo 
using permuted block technique based on cancer origin. Patients and 
investigators are blinded to assignment.  Only the Investigational Drug Service 
will maintain the blinded codes. Patient and investigator will be unblinded at the 
conclusion of the study. Patients are randomized 1:1 to each arm. 
 
Randomization will be stratified by pathological category of cancer type.  
Thirty subjects will be randomized within each of three groups: 
1. Ovarian, fallopian tube, primary peritoneal cancer 
2. Endometrial cancer 
3. Cervical cancer 
 
 
5.2.3 Evaluation of sexual dysfunction 
 
The survey packet evaluates physical, psychological, and social elements related 
to sexuality. Each packet will be assembled into a large envelope and handed to 
the subject by the healthcare provider in the UIHC Gynecologic Oncology 
outpatient clinic.  The surveys will be completed by the subject in the clinic (in a 
private area) on the day of the visit and then collected by the research data 
managers. 
 
Each survey packet will contain: 
 
1.  Female Sexual Function Index:  A self-report measure of sexual 
functioning 
  
2.  Patient Health Questionnaire 9 (PHQ-9):  Instrument for screening, 
diagnosing, monitoring, and measuring the severity of depression.   
  


 
 
 
 
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3.  Generalized Anxiety Disorder 7-item scale (GAD-7):  A brief measure for 
assessing generalized anxiety disorder.  
  
4.  Social Provisions Scale (SPS):  Instrument to assess provisions of social 
relationships. 
  
5.  Rosenberg’s Body Self-Esteem Index:  Scale that measures global self-
worth by measuring both positive and negative feelings about the self.  
  
6.  Severity of Posttraumatic Stress Symptoms-Adult:  Assesses the severity 
of posttraumatic stress disorder following a particular event or experience. 
  
7.  Adverse Childhood Events Index:  A scale measuring types of physical, 
verbal, and emotional childhood trauma 
  
8.  SF-12:  A generic measure of health status 
  
9.  Dyadic Adjustment Scale:  A relationship adjustment self-report measure. 
 
5.2.4 Diary of Sexual Encounters 
 
A diary of sexual encounters during the 24 weeks of observation will be kept by 
participating subjects.  On the calendar, subjects will be asked to document date 
of sexual encounter and an accompanying successful or unsuccessful perineal 
application of the intervention.  For each encounter, subjects will also be asked to 
mark a visual pain scale. 
 
5.2.5  Adverse Events 
 
Study participants will be asked if there have been any reactions to the solution 
supplied for perineal application at each clinic visit.  They will be encouraged to 
contact their primary gynecologic oncologist or the study chair immediately 
should any adverse reactions be experienced with the perineal application. 
 
Each questionnaire packet will be reviewed immediately following collection for 
an immediate assessment to positive responses to the depression and suicidal 
ideation items of the PHQ-9.  If the PHQ-9 score reflects severe depression, the 
clinician overseeing the patient’s care for their gynecologic malignancy will be 
notified and asked to use their clinical discretion for intervention and appropriate 
referrals within the UIHC health system. 
 
6. Study Procedures 
 
6.1 Self-reported measures of physical, psychological and social stressors 
influencing sexual function  
 
Patient-completed surveys, measuring the different elements of sexual dysfunction, 
will be completed at their initial visit, following their assessment by a UIHC 


 
 
 
 
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gynecologic oncologist, and their decision to pursue a surgical intervention for their 
gynecologic cancer.   At the twelve week postoperative visit, and if a pathologic 
diagnosis of cancer is confirmed, subjects will be asked to complete the same 
survey packet.  At subsequent 3 and 6 month follow-up visits, subjects will be asked 
to complete the survey packet following the visit with their gynecologic oncology 
healthcare provider. 
 
6.2  Aqueous Lidocaine and Placebo Perineal Application 
 
Once subjects have a confirmed diagnosis of their gynecologic cancer, and they 
complete the survey packet at their 12-week follow-up visit, they will be randomized 
to receive a solution containing either aqueous lidocaine or a placebo.  They will also 
be given a package of cotton balls with instructions to put the solution on three 
cotton balls and apply them to the perineum/vaginal introitus for one minute prior to 
sexual intercourse.  Subjects will be asked to document in their diary successful or 
unsuccessful application of the perineal solution.  They will also be asked to 
complete a visual pain scale for each sexual encounter. Subjects will be reminded to 
bring the calendars to the return visit with a phone call. 
 
The aqueous lidocaine/placebo solution will be supplied by the Investigational Drug 
Service. It will be labeled in a manner that does not identify the presence of active 
ingredient.  
 
CALENDAR/SCHEDULE OF EVENTS 
   
 
 
 
Visit 1     
Pre-surgery 
 
 
 
Visit 2      
(12 weeks 
post-
surgery) 
 
 
Visit 3        
(24 weeks 
post-surgery) 
 
 
 
Visit 4        
(32 weeks 
post-surgery)   
 
 
 
Procedures 
 
Informed Consent 
 
x 
 
 
 
 
 
 
 
Inclusion / 
Exclusion Criteria 
 
x 
 
 
 
 
 
 
 
Performance 
Status 
 
x 
 
x 
 
x 
 
x 
 
Physical Exam 
 
x 
 
x 
 
x 
 
x 
 
Questionnaires 
 
x 
 
x 
 
x 
 
x 
Calendar 
Diary of Sexual 
encounters and 
lidocaine/placebo 
usage 
 
x 
x 
 
x 
 
x 
 
 
 
 
 
Randomization 
 
 
x 
 
 
 
 
 
 
 
 


 
 
 
 
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 7. Safety 
 
 
 
7.1  Possible Adverse events of lidocaine include:  
 
• Rare allergic reactions:  Itching; hives; edema of the face or hands; tingling in 
the mouth or throat or chest tightness (which can cause trouble breathing). 
• Other uncommon reactions:  Blurred or double vision; confusion; dizziness; 
lightheadedness; or drowsiness; chest pain or an uneven heartbeat; skin rash; 
swelling in the area where this medicine is applied; and trembling (shaking). 
 
7.2 Other risks of the study procedures include:  
 
• Embarrassment:  discomfort answering some of the questions of the surveys 
(subjects may skip any questions they choose). 
 
7.3  Stopping Rules: 
 
• Subject may stop participating at any time 
• Subject not following instructions  
• Gel becomes unavailable 
• Attending physician decision to withdraw subject 
• Breach of confidentiality 
 
8. Statistical Evaluation/Considerations 
 
The primary objective of this double-blinded, randomized, placebo-controlled study 
is to assess the relative efficacy of aqueous lidocaine solution in improving sexual 
functioning within the population of females undergoing a primary surgical procedure 
for the treatment of ovarian, endometrial, and cervical cancer. Sexual functioning will 
be assessed using the self-reported Female Sexual Function Index (FSFI; full scale 
score ranges from 2 to 36 where scores <26 are indicative of sexual dysfunction). 
Given the lack of existing literature pertaining to sexual functioning immediately 
following surgical intervention, this will be a pilot study aimed at obtaining estimates 
of relative efficacy as well as assessing feasibility. Existing literature on sexual 
functioning in gynecologic cancer survivors, assessed a year or more post-surgery, 
provide median and mean estimates ranging between 16.6-17.2 and 19.75-19.9 (SD 
7.0-9.8), respectively, on the FSFI full scale [6, 7, 8, 9]. We anticipate sexual 
functioning will be even lower in the 24 weeks immediately following surgery. A 
sample size of 15 patients per treatment group achieves 80% power to detect an 
increase of 9.3 between the null hypothesis that both group means are 17.0 and the 
alternative hypothesis that the mean of the aqueous lidocaine solution treatment 
group is 26.3 with estimated group standard deviations of 10.0 and a significance 
level of 0.05. Power calculations were based on using a one-sided two-sample t-test 
for a single point in time while assuming the actual distribution of the FSFI full scale 
is normal. Accordingly, 30 patients from each cancer type—ovarian, endometrial, 
and cervical—will be recruited for a total of 90 subjects. 
 


 
 
 
 
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To assess changes in sexual, physical, psychological, and social domains, linear 
mixed effects regressions models will be utilized. Random effects will be employed 
to account for the longitudinally correlated nature of repeated questionnaire 
measurements.  
 
9. Data Collection and Record Keeping  
 
9.1 Data will be collected primarily by paper forms that include reported information 
from each study participant. Information will be transferred to electronic database 
collection documents for use by the statisticians without any identifiable information.  
 
9.2 In order to protect confidentiality the subject will be assigned an identification 
number. This number will be used on all specimens from the subject and will be 
used for documentation purposes. Data management for the entry, processing, 
storage, and retrieval for this protocol's data will be managed by the principal 
investigator. The database will be located on a computer or in a locked cabinet in a 
locked office. This computer will be secured using UIHC standard protections and 
accessible only by the research team. For quality control, auditing, and data 
integrity, there will be a regular review of data performed periodically throughout the 
data collection phase. 
 
9.3 Study data will be maintained according to University of Iowa policies. Since this 
project includes protected health information, copies of all research records will be 
stored for at least six years following study closure. Study documents will be stored 
in a secure storage room of the department for the required amount of time. The 
space is only accessible to relevant study staff.  
 
 
10. References  
[1] Abbott-Anderson K, Kwekkeboom KL. A systematic review of sexual concerns 
reported by gynecological cancer survivors. Gynecol Oncol. 2012 Mar; 124(3):477-89. 
 
[2] U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2011 
Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and 
Human Services, Centers for Disease Control and Prevention and National Cancer 
Institute; 2014. Available at: www.cdc.gov/uscs. 
 
[3] Anderson BL, Anderson B, deProsse C. Controlled prospective longitudinal study of 
women with cancer: I. Sexual functioning outcomes. J Consult Clin Psychol. 1989 
Dec;57(6):683-91. 
 
[4] Anderson BL, Anderson B, deProsse C. Controlled prospective longitudinal study of 
women with cancer: II. Psychological outcomes. J Consult Clin Psychol. 1989 
Dec;57(6):692-7. 
 
[5] Goetsch MF, Lim JY, Caughey AB. Locating pain in breast cancer survivors 
experiencing dyspareunia: A randomized controlled trial. Obstetrics and Gynecology. 
2014 Jun;123(6):1231-1236. 


 
 
 
 
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[6]  Serati M, Salvatore S, Uccella S, Laterza RM, Cromi A, Ghezzi F, Bollis P.  Sexual 
function after radical hysterectomy for early-stage cervical cancer:  is there a difference 
between laparoscopy and laparotomy?  J Sex Med.  2009 Sep; 6(9):2516-22. 
 
[7]  Onujiogu N, Johnson T, Seo S, Mijal K, Rash J, Seaborne L, Rose S, Kushner DM.  
Survivors of endometrial cancer:  who is at risk for sexual dysfunction?  Gynecol Oncol.  
2011 Nov;123(2):356-9. 
 
[8]  Carter J, Chi DS, Brown CL, Abu-Rustum NR, Sonoda Y, Aghajanian C, Levine DA, 
Baser RE, Raviv L, Barakat RR.  Int J Gynecol Cancer.  Cancer-related infertility in 
survivorship.  2010 Jan;20(1):2-8. 
 
[9]  Kim SI, Lee Y, Lim MC, Joo J, Park K, Lee DO, Park SY. Quality of life and sexuality 
comparison between sexually active ovarian cancer survivors and healthy women.  J. 
Gynecol Oncol 2015 Apr;26(2):148-54.  
 
 

ICF_001.pdf: 
FOR IRB USE ONLY 
APPROVED BY: IRB-01 
IRB ID #: 201609770 
APPROVAL DATE: 05/29/19 
EXPIRATION DATE: 01/10/20 
 
 
 
Page 1 of 7 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Sexual Dysfunction in Gynecologic Oncology Patients 
 
Principal Investigator: 
David Bender, MD  
 
Research Team Contact: 
David Bender, MD  
Erika Holm-Brown 
 
(319) 356-2015 
 
(319) 384-6076 
 
 
 
 
 
 
 
 
erika-holm@uiowa.edu 
 
 
This consent form describes the research study to help you decide if you want to participate.  This form 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights as a research subject.   
• If you have any questions about or do not understand something in this form, you should ask 
the research team for more information.   
• You should discuss your participation with anyone you choose such as family or friends.   
• Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We are inviting you to participate in this research study because you may have 
gynecologic cancer. 
 
The purpose of this research study is to look at sexual functioning in cancer survivors and how it affects 
quality of life. Another purpose is to see if lidocaine can help with sexual-related discomfort and 
functioning in women who have had surgery for their cancer.  
 
Lidocaine is a medicine that helps relieve pain and is an ingredient in a lot of over-the-counter pain gels 
and ointments. We would like to see how it could affect any possible discomfort that a woman could 
experience after surgery for gynecologic cancer. 
  
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 120 people will take part in this study conducted by investigators at the University of 
Iowa.   
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for up to one year. You will complete 
questionnaires four times during your regular visits to the gynecologic oncology clinic. The 
questionnaires may add about 30 minutes to your regular clinic visit.  
 


FOR IRB USE ONLY 
APPROVED BY: IRB-01 
IRB ID #: 201609770 
APPROVAL DATE: 05/29/19 
EXPIRATION DATE: 01/10/20 
 
 
 
Page 2 of 7 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
Summary: 
If you agree to participate in the study, you will complete a set of questionnaires at four time points and 
use a solution supplied by the research team when you have sexual intercourse. You will also keep track 
of your sexual encounters and pain levels during sex while you are participating in the study. The 
questionnaires will take about 30 minutes to complete. 
 
Timeline: 
Before your planned surgery, you will complete a set of questionnaires about your health, daily living, 
sexual encounters, pain, and general questions about how you are feeling. This will happen at one of 
your visits to the doctor’s office. You will also have a physical exam that is part of your regular cancer 
care during these visits.  
 
Then you will have your surgery.   
 
Twelve weeks after your surgery, you will return to the doctor’s office for a routine exam and to 
complete the same set of surveys as before your surgery. You will then be given a solution to use when 
you have sexual encounters that you apply to the outside of your vagina.  
 
The solution will either contain lidocaine (a numbing medication) or it will be a placebo and 
contain no active ingredient. You will be randomly assigned to receive the lidocaine or placebo. 
This means that whichever study treatment you receive will be determined purely by chance, 
like flipping a coin.  You will have a 50/50 chance of receiving either of the study solutions. 
The placebo solution will look like the solution with the active lidocaine, so you won’t know if 
you have the lidocaine or the placebo. Neither you nor your doctor will know what type of 
solution you will have while you are using it in the study, but we will be able to get this 
information quickly if necessary.  
 
To use the solution, you will soak three cotton balls in about two teaspoons of the solution. You 
will then hold the cotton balls on the skin just outside of your vagina for a minute before you 
have intercourse. You will get further detailed instructions about how to use the solution from 
your study doctor or the study team.  
 
Please do NOT use any other lubricants or aids for sexual intercourse while you are participating in this 
study.  
 
Twelve weeks later, you will come back to the doctor’s office and complete the same set of surveys 
again and have a routine physical exam.  
 
You will continue to use the solution and record your pain level when you have sexual encounters.  
 
Finally, twelve weeks after this, you will return to the doctor’s office for a routine physical exam and 
complete the same set of surveys for a fourth time.  
 
After you have completed this portion of the study and about 9 months after your surgery, your doctor 


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EXPIRATION DATE: 01/10/20 
 
 
 
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can discuss with you any future recommendations about sexual health and pain management. However, 
you may not know which solution you received yet.  
 
All of these visits will occur at the same time as your regular cancer care follow-up visits to the doctor’s 
office, which include physical exams, so there won’t be any extra office visits necessary to be in the 
study.  
 
Information will be collected from your medical record to support the research study, such as your age 
and disease history and information from your physical examinations. We will not enter any information 
from the research study procedures or the questionnaires into your medical chart. 
 
Unblinding: 
You will be told which solution you were randomized to receive at the end of the study, which may be 
after your last study visit. You will receive a letter in the mail telling you which solution you received 
during the study.  
 
You will be told which solution you received during the study only if it is medically necessary (for 
example, if you are having a reaction and need to know which solution is used to treat you properly). 
 
If you are unblinded and told which solution you are getting during your participation in the study, you 
will not continue to participate.  
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks indicated below from being in this study. In addition to 
these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.  
 
The use of the numbing solution (lidocaine) can rarely cause the following allergic reaction: Itching or 
hives that can produce swelling in your face or hands, swelling or tingling in your mouth or throat or 
chest tightness (which can cause trouble breathing).   
 
Also very uncommon reactions can include: blurred or double vision; confusion, dizziness, 
lightheadedness, or drowsiness; chest pain, or an uneven heartbeat; skin rash; swelling in the area where 
this medicine is applied; and trembling (shaking). 
 
These risks could also affect your sexual partner since they may have contact with the solution.  
 
You may feel uncomfortable answering some of the questions on the surveys. You are free to skip any 
questions you do not want to answer.  
 
The study staff will notify appropriate personnel/authorities if you indicate thoughts of harming yourself 
or others. 
 


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EXPIRATION DATE: 01/10/20 
 
 
 
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WHAT ARE THE BENEFITS OF THIS STUDY? 
 
We don’t know if you will benefit from being in this study. 
 
However, we hope that, in the future, other people might benefit from this study because we can learn 
about sexual function in cancer survivors and know if something like a numbing solution might help 
these women have better sexual health and overall life satisfaction.  
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
You will not have any costs for being in this research study. 
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will not be paid for being in this research study.   
 
WHO IS FUNDING THIS STUDY? 
 
The Iowa Cancer Consortium is funding this research study.  This means that the University of Iowa is 
receiving payments from the Iowa Cancer Consortium to support the activities that are required to 
conduct the study.  No one on the research team will receive a direct payment or increase in salary from 
Iowa Cancer Consortium for conducting this study. 
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
• If you are injured or become ill from taking part in this study, medical treatment is available at the 
University of Iowa Hospitals and Clinics. 
• The University of Iowa does not plan to provide free medical care or payment for treatment of any 
illness or injury resulting from this study unless it is the direct result of proven negligence by a 
University employee.  
• If you experience a research-related illness or injury, you and/or your medical or hospital insurance 
carrier will be responsible for the cost of treatment. 
 
 
WHAT ABOUT CONFIDENTIALITY? 
 
We will keep your participation in this research study confidential to the extent permitted by law.  
However, it is possible that other people such as those indicated below may become aware of your 
participation in this study and may inspect and copy records pertaining to this research.  Some of these 
records could contain information that personally identifies you.  
• federal government regulatory agencies,  
• The Iowa Cancer Consortium  
• auditing departments of the University of Iowa, and  
• the University of Iowa Institutional Review Board (a committee that reviews and approves 
research studies)  


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To help protect your confidentiality, we will only use random study ID numbers to identify you when 
possible and keep any information in locked offices or secure computer systems. The ID number will 
not include anything that will identify you personally.  If we write a report or article about this study or 
share the study data set with others, we will do so in such a way that you cannot be directly identified. 
 
The University of Iowa Hospitals and Clinics generally requires that we document in your medical 
record chart that you are participating in this study. The information included in the chart will provide 
contact information for the research team as well as information about the risks associated with this 
study. We will keep this Informed Consent Document in our research files; it will not be placed in your 
medical record chart.  
 
WILL MY HEALTH INFORMATION BE USED DURING THIS STUDY? 
 
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires University of Iowa 
Health Care to obtain your permission for the research team to access or create “protected health 
information” about you for purposes of this research study.  Protected health information is information 
that personally identifies you and relates to your past, present, or future physical or mental health 
condition or care.  We will access or create health information about you, as described in this document, 
for purposes of this research study.  Once University of Iowa Health Care has disclosed your protected 
health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but 
we will continue to protect your confidentiality as described under “Confidentiality.” 
 
We may share your health information related to this study with other parties including federal 
government regulatory agencies and the University of Iowa Institutional Review Boards and support 
staff. The sponsor, the Iowa Cancer Consortium, may also inspect any part of your medical record for 
the purposes of auditing the conduct of the study. 
 
You cannot participate in this study unless you permit us to use your protected health information.  If 
you choose not to allow us to use your protected health information, we will discuss any non-research 
alternatives available to you.  Your decision will not affect your right to medical care that is not 
research-related.  Your signature on this Consent Document authorizes University of Iowa Health Care 
to give us permission to use or create health information about you. 
 
Although you may not be allowed to see study information until after this study is over, you may be 
given access to your health care records by contacting University of Iowa Health Care. Your permission 
for us to access or create protected health information about you for purposes of this study has no 
expiration date. You may withdraw your permission for us to use your health information for this 
research study by sending a written notice to Dr. David Bender at University of Iowa Hospitals and 
Clinics, Department of Obstetrics and Gynecology, 200 Hawkins Drive, 31506 PFP, Iowa City, IA 
52242.   However, we may still use your health information that was collected before withdrawing your 
permission.  Also, if we have sent your health information to a third party, such as the study sponsor, or 
we have removed your identifying information, it may not be possible to prevent its future use.  You will 
receive a copy of this signed document. 
 


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IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time.  If you decide not to be in this 
study, or if you stop participating at any time, you won’t be penalized or lose any benefits for which you 
otherwise qualify. 
 
Can Someone Else End my Participation in this Study? 
 
Under certain circumstances, the researchers might decide to end your participation in this research 
study earlier than planned.  This might happen because you aren’t following the instructions or if the 
solution becomes unavailable or if the study doctor feels it is best for you to discontinue.   
 


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EXPIRATION DATE: 01/10/20 
 
 
 
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WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself or 
experience a research-related injury, please contact: Dr. David Bender at (319) 356-2015.  
 
If you have questions, concerns, or complaints about your rights as a research subject or about research 
related injury, please contact the Human Subjects Office, 105 Hardin Library for the Health Sciences, 
600 Newton Rd, The University of Iowa, Iowa City, IA  52242-1098, (319) 335-6564, or e-mail 
irb@uiowa.edu.  General information about being a research subject can be found by clicking “Info for 
Public” on the Human Subjects Office web site, http://hso.research.uiowa.edu/. To offer input about 
your experiences as a research subject or to speak to someone other than the research staff, call the 
Human Subjects Office at the number above. 
 
 
This Informed Consent Document is not a contract. It is a written explanation of what will happen 
during the study if you decide to participate. You are not waiving any legal rights by signing this 
Informed Consent Document. Your signature indicates that this research study has been explained to 
you, that your questions have been answered, and that you agree to take part in this study.  You will 
receive a copy of this form. 
 
Subject's Name (printed):  __________________________________________________________ 
 
 
Do not sign this form if today’s date is on or after EXPIRATION DATE: 01/10/20. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Subject)  
 
 
 
 
(Date) 
 
 
Statement of Person Who Obtained Consent 
 
I have discussed the above points with the subject or, where appropriate, with the subject’s legally 
authorized representative.  It is my opinion that the subject understands the risks, benefits, and 
procedures involved with participation in this research study. 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date)