Clinical trial NCT01444911: Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
Official title: Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sexual Dysfunction, Physiological
Keywords: Sexual Dysfunction
Gynecologic cancer
Cancer survivor
Vaginal dilator
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
timeFrame: At baseline and 6 months
Secondary outcomes:
measure: Change in Marinoff Scale at 6 Months
timeFrame: At baseline and 6 months
measure: FACT-G Score
timeFrame: At baseline and 6 months
measure: Vaginal Length
timeFrame: At baseline and 6 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: David M Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References: