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

NCT03547089 | Suspended DMC FDA Device

• 1 other identifier: VI-ISRP-026
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Atrophy; Genitourinary System; Disorder, Female; Vaginal Abnormality; Sexual Dysfunction; Sexual Problem

Outcome Measures

Primary Outcomes (1)

• Sexual dysfunction

  Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)

  Baseline, 1 month, 3 months, 6 months

Secondary Outcomes (3)

• Sexual distress

  Baseline, 1 month, 3 months, 6 months

• Vaginal symptoms

  Baseline, 1 month, 3 months, 6 months

• Vaginal laxity

  Baseline, 1 month, 3 months, 6 months

Study Arms (1)

Viveve treatment

EXPERIMENTAL

Group of women who receive Viveve treatment

Device: Viveve®

Interventions

Viveve® DEVICE

A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2

Viveve treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W. Grant Stevens, MD: lead

Study Sites (1)

Marina Plastic Surgery Associates

Marina del Rey, California, 90292, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• W G Stevens, MD

  Marina Plastic Surgery

  PRINCIPAL INVESTIGATOR

• Ali A Qureshi, MD

  Marina Plastic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 6, 2018
• Study Start: August 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

US (1)