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

Sexual Dysfunction, Physiological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01444911
• Other study ID #: 2011-0217
• Secondary ID: OS10706NCI-2011-
• Status: Terminated
• Phase: Phase 2
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sexual Dysfunction, Physiological

Intervention

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.
• Vaginal Dilator
Still vaginal dilator with lubricant.

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Vaginal Length	Change in vaginal length as measured from baseline to 6 months.	At baseline and 6 months

External Links

•   University of Wisconsin Carbone Cancer Center