Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
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.
|Sexual Dysfunction, Physiological||Device: Vaginal Renewal Program Device: Vaginal Dilator||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial|
- FSFI score [ Time Frame: 6 months ]FSFI is the Female Sexual Function Index, which is a 19-item sexual functioning questionnaire.
- Marinoff scale [ Time Frame: 6 months ]The Marinoff dyspareunia scale measures pain with intercourse.
- FACT-G score [ Time Frame: 6 months ]The FACT-G questionnaire assess general functioning in cancer patients.
- Vaginal length [ Time Frame: 6 months ]
|Study Start Date:||August 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Vaginal Renewal Program||
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.
Active Comparator: Standard of care
This will consist of still vaginal dilator and/or lubricant.
Device: Vaginal Dilator
Still vaginal dilator with lubricant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444911
|United States, Wisconsin|
|University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||David M Kushner, MD||University of Wisconsin, Madison|