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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2
Marina Plastic Surgery Associates
Marina del Rey, California, United States
Sexual dysfunction
Measurement of changes in sexual dysfunction using the Female Sexual Function Index (FSFI)
Time frame: Baseline, 1 month, 3 months, 6 months
Sexual distress
Measurement of changes in sexual distress using the Female Sexual Distress Scale-Revised (FSDS-R)
Time frame: 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
Time frame: Baseline, 1 month, 3 months, 6 months
Vaginal laxity
Measurement of changes in vaginal laxity using the Vaginal Laxity Questionnaire (VLQ)
Time frame: Baseline, 1 month, 3 months, 6 months
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