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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

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

Intervention / Treatment
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* Device: Viveve®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |