A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment Outcomes (BRAVO)

A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment

The focus of this study is to assess breast cancer survivors perspectives of Viveve® Treatment using patient reported outcome tools with a focus on symptoms associated with vulvovaginal atrophy/genitourinary syndrome of menopause (GSM). This will be assessed by the FSFI, FSDS-R and DIVA questionnaires.

Study Overview

• Status: Suspended
• Conditions: Sexual Dysfunction; Vaginal Atrophy; Vaginal Abnormality; Genitourinary System; Disorder, Female; Sexual Problem
• Intervention / Treatment: Device: Viveve®

Detailed Description

Breast cancers that are hormone sensitive require estrogen suppression as a part of multimodal treatment. Estrogen suppression also reduces the likelihood of a breast cancer recurrence. Therefore, breast cancer survivors with estrogen sensitive tumors are placed on hormone suppression therapy with either selective estrogen receptor modulators like tamoxifen or aromatase inhibitors like anastrazole. This therapy typically is administered for five years after a cancer diagnosis. Regardless of age or pre-existing menopausal status, the hormone suppression reduces estrogen levels and can either exacerbate existing menopausal symptoms or induce medical menopause in otherwise premenopausal women. This study will evaluate the patient's perspective of vaginal therapy using the Viveve® device in breast cancer patients.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Marina Del Rey, California, United States, 90292
      • Marina Plastic Surgery Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key Inclusion Criteria:

• 18 years or older
• Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on tamoxifen
• Self-reported vaginal laxity
• Meet diagnosis of sexual dysfunction
• Patients must be able to understand and willing to sign a written informed consent document and be willing to complete the patient reported outcome tools at the scheduled time points

Exclusion Criteria:

• Cognitive impairment
• Women currently on chemotherapy and/or radiation or who have had their last chemotherapy within 6 months of the intervention
• Women with active breast cancer disease
• Women currently on hormone therapy or who are pregnant
• Women who have had vaginal or pelvic surgery involving the genitalia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Viveve treatment; Group of women who receive Viveve treatment	Device: Viveve®; A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual dysfunction	Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)	Baseline, 1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual distress	Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)	Baseline, 1 month, 3 months, 6 months
Vaginal symptoms	Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire	Baseline, 1 month, 3 months, 6 months
Vaginal laxity	Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)	Baseline, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: W. Grant Stevens, MD
• Investigators: Principal Investigator: W G Stevens, MD, Marina Plastic Surgery; Study Director: Ali A Qureshi, MD, Marina Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: VI-ISRP-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No