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



Status:Completed
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:August 2011
End Date:September 2013
Contact:Cancer Connect
Email:cancerconnect@uwcarbone.wisc.edu
Phone:800-622-8922

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


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.


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
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