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

This study has been terminated.
(Slow accrual)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01444911
First received: September 29, 2011
Last updated: July 10, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • FSFI score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    FSFI is the Female Sexual Function Index, which is a 19-item sexual functioning questionnaire.


Secondary Outcome Measures:
  • Marinoff scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The Marinoff dyspareunia scale measures pain with intercourse.

  • FACT-G score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The FACT-G questionnaire assess general functioning in cancer patients.

  • Vaginal length [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01444911     History of Changes
Other Study ID Numbers: 2011-0217, OS10706
Study First Received: September 29, 2011
Last Updated: July 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014