NCT01444911

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

July 27, 2017

Completed
Last Updated

December 9, 2019

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

September 29, 2011

Results QC Date

January 24, 2017

Last Update Submit

November 19, 2019

Conditions

Sexual Dysfunction, Physiological

Keywords

Sexual DysfunctionGynecologic cancerCancer survivorVaginal dilator

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Marinoff Scale at 6 Months

    At baseline and 6 months

  • FACT-G Score

    At baseline and 6 months

  • Vaginal Length

    At baseline and 6 months

Study Arms (2)

Vaginal Renewal Program

EXPERIMENTAL
Device: Vaginal Renewal Program

Standard of care

ACTIVE COMPARATOR

This will consist of still vaginal dilator and/or lubricant.

Device: Vaginal Dilator

Interventions

Vaginal Renewal ProgramDEVICE

The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.

Vaginal Renewal Program
Vaginal DilatorDEVICE

Still vaginal dilator with lubricant.

Standard of care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18
  • History of a gynecologic cancer
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Limitations and Caveats

The study was closed before completion due to a slowing accrual rate.

Results Point of Contact

Title
Dr. David Kushner
Organization
University of Wisconsin Carbone Cancer Center
dmkushner@facstaff.wisc.edu
608-263-1210

Study Officials

  • David M Kushner, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 3, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 9, 2019

Results First Posted

July 27, 2017

Record last verified: 2017-07

Locations

US(1)