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

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2

Conditions: Sexual Dysfunction, Physiological

Treatments: Device: Vaginal Renewal Program; Device: Vaginal Dilator

Study type: Interventional

Funder types: Other

Identifiers

NCT01444911

NCI-2011-03674 (Registry Identifier)

SMPH\OBSTET & GYNEC\GYNEC ONC (Other Identifier)

2011-0217

A532820 (Other Identifier)

OS10706 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Vaginal Renewal Program

Experimental group

Treatment:

Device: Vaginal Renewal Program

Standard of care

Active Comparator group

Description:

This will consist of still vaginal dilator and/or lubricant.

Treatment:

Device: Vaginal Dilator