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

Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Sexual Dysfunction, Physiological
• Intervention / Treatment: Device: Vaginal Renewal Program; Device: Vaginal Dilator

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Female Sexual Function Index (FSFI) Score at 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.	At baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Marinoff Scale at 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.	At baseline and 6 months
FACT-G Score	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.	At baseline and 6 months
Vaginal Length	Change in vaginal length as measured from baseline to 6 months.	At baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): October 3, 2011

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Cancer survivor; Sexual Dysfunction; Gynecologic cancer; Vaginal dilator
• Additional Relevant MeSH Terms: Sexual Dysfunction, Physiological
• Other Study ID Numbers: 2011-0217; A532820 (Other Identifier: UW Madison); SMPH\OBSTET & GYNEC\GYNEC ONC (Other Identifier: UW Madison); OS10706 (Other Identifier: University of Wisconsin Carbone Cancer Center); NCI-2011-03674 (Registry Identifier: NCI Trial ID)