NCT01444911 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: TERMINATED
Registry last update: 2019-12-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months

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outcome · POSTED

Change in Marinoff Scale at 6 Months

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outcome · POSTED

FACT-G Score

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outcome · POSTED

Vaginal Length

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Device: Vaginal Renewal Program
label
Vaginal Renewal Program
type
EXPERIMENTAL
description
This will consist of still vaginal dilator and/or lubricant.
intervention Names
Device: Vaginal Dilator
label
Standard of care
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Vaginal Renewal Program
description
The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
name
Vaginal Renewal Program
type
DEVICE
arm Group Labels
Standard of care
description
Still vaginal dilator with lubricant.
name
Vaginal Dilator
type
DEVICE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 29
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Change From Baseline in Female Sexual Function Index (FSFI) Score at 6 Months
time Frame
At baseline and 6 months

secondary Outcomes

description
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.
measure
Change in Marinoff Scale at 6 Months
time Frame
At baseline and 6 months
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.
measure
FACT-G Score
time Frame
At baseline and 6 months
description
Change in vaginal length as measured from baseline to 6 months.
measure
Vaginal Length
time Frame
At baseline and 6 months

Full 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.

Source references