Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
Primary Purpose
Sexual Dysfunction, Physiological
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vaginal Renewal Program
Vaginal Dilator
Sponsored by
About this trial
This is an interventional supportive care trial for Sexual Dysfunction, Physiological focused on measuring Sexual Dysfunction, Gynecologic cancer, Cancer survivor, Vaginal dilator
Eligibility Criteria
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
Sites / Locations
- University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vaginal Renewal Program
Standard of care
Arm Description
This will consist of still vaginal dilator and/or lubricant.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Vaginal Length
Change in vaginal length as measured from baseline to 6 months.
Full Information
NCT ID
NCT01444911
First Posted
September 29, 2011
Last Updated
November 19, 2019
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01444911
Brief Title
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
Official Title
Evaluation of a Multifaceted Vaginal Renewal™ Program Utilizing Vibrating Wands in Gynecologic Cancer Patients Experiencing Sexual Dysfunction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
August 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Physiological
Keywords
Sexual Dysfunction, Gynecologic cancer, Cancer survivor, Vaginal dilator
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaginal Renewal Program
Arm Type
Experimental
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
This will consist of still vaginal dilator and/or lubricant.
Intervention Type
Device
Intervention Name(s)
Vaginal Renewal Program
Intervention Description
The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
Intervention Type
Device
Intervention Name(s)
Vaginal Dilator
Intervention Description
Still vaginal dilator with lubricant.
Primary Outcome Measure Information:
Title
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
Description
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.
Time Frame
At baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Marinoff Scale at 6 Months
Description
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.
Time Frame
At baseline and 6 months
Title
FACT-G Score
Description
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.
Time Frame
At baseline and 6 months
Title
Vaginal Length
Description
Change in vaginal length as measured from baseline to 6 months.
Time Frame
At baseline and 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Kushner, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center
Learn more about this trial
Evaluation of The Vaginal Renewal™ Program in Gynecologic Cancer Patients Experiencing Sexual Dysfunction
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