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

This study has been terminated.
(Slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444911
First Posted: October 3, 2011
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose

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.


Condition Intervention Phase
Sexual Dysfunction, Physiological Device: Vaginal Renewal Program Device: Vaginal Dilator Phase 2

Study Type: Interventional
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

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

    1. = pain with intercourse that doesn't prevent the completion
    2. = pain with intercourse requiring interruption or discontinuance
    3. = 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.


Enrollment: 29
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444911


Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin, United States
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David M Kushner, MD University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01444911     History of Changes
Other Study ID Numbers: 2011-0217
OS10706 ( Other Identifier: UWCCC )
First Submitted: September 29, 2011
First Posted: October 3, 2011
Results First Submitted: January 24, 2017
Results First Posted: July 27, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017

Keywords provided by University of Wisconsin, Madison:
Sexual Dysfunction
Gynecologic cancer
Cancer survivor
Vaginal dilator

Additional relevant MeSH terms:
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female