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

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ClinicalTrials.gov Identifier: NCT03547089
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
W. Grant Stevens, MD, Marina Plastic Surgery

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy Genitourinary System; Disorder, Female Vaginal Abnormality Sexual Dysfunction Sexual Problem Device: Viveve® Not Applicable

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 nonsurgical vulvovaginal rejuvenation (NVR) using the Viveve® device in breast cancer patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial to Assess Breast Cancer Survivors and Vaginal Atrophy Treatment
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Sexual dysfunction [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)


Secondary Outcome Measures :
  1. Sexual distress [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)

  2. Vaginal symptoms [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Measurement of changes in vaginal symptoms using the Day-to-Day Impact of Vaginal Aging (DIVA) Questionnaire

  3. Vaginal laxity [ Time Frame: Baseline, 1 month, 3 months, 6 months ]
    Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 18 years or older
  • Breast cancer survivors defined as women with a history of hormone sensitive breast cancer on aromatase inhibitor
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547089


Contacts
Contact: Ali A Qureshi, MD (877) 298-9915 qureshiaa4@gmail.com

Locations
United States, California
Marina Plastic Surgery Associates Recruiting
Marina Del Rey, California, United States, 90292
Contact: Ali Qureshi, MD    877-298-9915    qureshiaa4@gmail.com   
Sponsors and Collaborators
W. Grant Stevens, MD
Investigators
Principal Investigator: W G Stevens, MD Marina Plastic Surgery
Study Director: Ali A Qureshi, MD Marina Plastic Surgery

Responsible Party: W. Grant Stevens, MD, Director, Marina Plastic Surgery
ClinicalTrials.gov Identifier: NCT03547089     History of Changes
Other Study ID Numbers: VI-ISRP-026
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical