Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction

Study Overview
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Brief Summary
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This is a randomized controlled trial designed to evaluate the effect of the Vaginal Renewal™ Program (VRP), consisting of the use of a vibrating vaginal wand, manual massage and a water based lubricant, on sexual dysfunction, compared to the current standard care for women with no evidence of disease after treatment for gynecologic cancers. In the University of Wisconsin gynecologic oncology and radiation oncology clinics, patients are generally asked about sexual function. Those women who report sexual dysfunction will be given the option to enroll in the study. After enrollment, the Female Sexual Function Index (FSFI) and other quality of life surveys will be administered at baseline. The participants will be randomized to either the control arm, composed of standard of care therapy for the physical components of sexual dysfunction, or the experimental arm (VRP). Throughout the study, the participants will undergo physical exams to assess the rate of improvement in their comfort with pelvic exams and changes in vaginal length. They will also be evaluated with the FSFI, Marinoff Scale for Dyspareunia, and Functional Assessment of Cancer Therapy-General (FACT-G) surveys at the end of the study to assess the magnitude of improvement in sexual function and quality of life.

Official Title
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Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial

Conditions
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Sexual Dysfunction, Physiological

Intervention / Treatment
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* Device: Vaginal Renewal Program
* Device: Vaginal Dilator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 History of a gynecologic cancer No evidence of disease at time of inclusion in the study Postmenopausal (either surgical or natural menopause) Self report of sexual dysfunction that did not predate cancer diagnosis Suspected physical component to sexual dysfunction with the participant, not sexual partner Desire to improve sexual function ECOG Performance status score of 2 or better Six months or greater from last surgical and/or radiation treatment Exclusion Criteria: History of sexual reassignment Presence of vaginal fistula Does not desire to improve sexual function Already using the vaginal renewal program Not fluent in English Incarceration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Renewal Program<br> | Device: Vaginal Renewal Program<br>* The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.<br>|
| Active Comparator: Standard of care<br>This will consist of still vaginal dilator and/or lubricant. | Device: Vaginal Dilator<br>* Still vaginal dilator with lubricant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months | Female Sexual Function Index (FSFI), uses a 19-item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | At baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Marinoff Scale at 6 Months | The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse = pain with intercourse that doesn't prevent the completion = pain with intercourse requiring interruption or discontinuance = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline. | At baseline and 6 months | 
| FACT-G Score | The FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire assesses general cancer quality-of-life measure for evaluating patients receiving cancer treatment. Scores range from 0 to 108, where 0 is low well-being and 108 is the highest well-being possible. Difference in score from baseline to 6 months is reported. | At baseline and 6 months | 
| Vaginal Length | Change in vaginal length as measured from baseline to 6 months. | At baseline and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Dysfunction, Gynecologic cancer, Cancer survivor, Vaginal dilator