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

Phase 2

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vaginal Renewal Program	Vaginal Renewal Program	-
Standard of care	Vaginal Dilator	This will consist of still vaginal dilator and/or lubricant.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months	At baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Vaginal Length	At baseline and 6 months	Change in vaginal length as measured from baseline to 6 months.
FACT-G Score	At baseline and 6 months	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.
Change in Marinoff Scale at 6 Months	At baseline and 6 months	The Marinoff dyspareunia scale measures pain with intercourse, measured from 0-3, according to the following scale: 0 = no pain with intercourse 1. = pain with intercourse that doesn't prevent the completion 2. = pain with intercourse requiring interruption or discontinuance 3. = pain with intercourse preventing any intercourse Difference in Marinoff scores reported, value at 6 months minus value at baseline.

Locations (1): University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
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Madison, Wisconsin, United States