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: None (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|
- Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months [ Time Frame: 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.
- Change in Marinoff Scale at 6 Months [ Time Frame: 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
- = pain with intercourse that doesn't prevent the completion
- = pain with intercourse requiring interruption or discontinuance
- = pain with intercourse preventing any intercourse
Difference in Marinoff scores reported, value at 6 months minus value at baseline.
- FACT-G Score [ Time Frame: 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.
- Vaginal Length [ Time Frame: At baseline and 6 months ]Change in vaginal length as measured from baseline to 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|