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

NCT01444911 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2019-12-09

Study results available
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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.

Conditions

  • Sexual Dysfunction, Physiological

Interventions

DEVICE

Vaginal Renewal Program

The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

DEVICE

Vaginal Dilator

Still vaginal dilator with lubricant.

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • David M Kushner, MD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01444911 on ClinicalTrials.gov