N/A
N=186
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
Vaginal Laxity Following Childbirth · Sexual Function Following Childbirth
Bottom Line
View on ClinicalTrials.gov: NCT02261974 ↗Enrolled (actual)
186
Serious AEs
0.6%
Results posted
Dec 2017
Primary outcome: Primary: Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score — 4.16; 2.36 Units on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Treatment Viveve (Device); Sham Treatment Viveve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Viveve Inc.
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Female Sexual Function Index (FSFI) Total Score |
4.16; 2.36 | — |
| PRIMARY Reporting Adverse Events (AEs) |
13; 7 | — |
| SECONDARY Mean Change From Baseline in Vaginal Introitus Laxity Inventory (VALI) Total Score |
7.28; 6.32 | — |
| SECONDARY Mean Change From Baseline in the VSQ Vaginal Laxity Question (VLQ) |
1.81; 1.07 | — |
| SECONDARY Mean Change From Baseline in Female Sexual Distress Scale - Revised (FSDS-R) |
-6.55; -4.13 | — |
Summary
Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design
The objective of this study is to determine the safety and effectiveness of the Viveve System to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving vaginal laxity.
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and voluntarily sign the informed consent form
- Pre-menopausal and ≥ 18 years of age
- At least one full term vaginal delivery (> 37 completed weeks gestation) at least 12 months prior to enrollment date
- Experiences vaginal looseness (laxity) during vaginal intercourse
- Subject must have a screening blood count and metabolic panel including FSH level of 14
- DSM-5 psychiatric diagnosis exhibiting clinically significant symptoms
- Taking SSNRI or SSRI drugs
- Not willing to abstain from vaginal intercourse or use of tampons until 10-day follow-up visit completed
- Evidence of active sexually transmitted disease upon vaginal exam that precludes treatment
- History of genital herpes
- Clinically significant abnormalities in clinical chemistry or hematology at the time of screening
- Currently taking prescribed medications, OTC products or supplements that may impact or enhance sexual function (e.g., antihypertensive, psychotropic, chemotherapeutic agent, PD5 Inhibitors) as assessed by the investigator
- Currently undergoing chemotherapy, radiation therapy, or pelvic floor physical therapy
- Has an implantable pacemaker, an automatic implantable cardioverter/defibrillator (AICD), or any other implantable electrical device, as these devices may be adversely affected by radiofrequency fields or current
- Has undergone the Viveve Procedure previously
- Has medical condition that in investigator's opinion may interfere with wound healing response
- Has an acute or a chronic vaginal or vulvar disorder (e.g., vaginal atrophy, pain including vulvodynia, vulvar vestibulitis dysethetic vulvodynia or vulvar dystrophy, current/chronic papulosquamous vulvar dermatoses (e.g., psoriasis lichen planus, tinea cruris, lichen sclerosis, seborrhea dermatitis, contact or irritant dermatitis, lichen simplex, eczema) or bullous dermatoses or systemic diseases with potential involvement of vulva)
- Has Irritable Bowel Syndrome or Crohn's Disease
- Has dyspareunia defined as recurrent or persistent painful intercourse that affects sexual activity
- Has been in another clinical study within four weeks of screening, or is not willing to abstain from enrolling in other clinical studies for duration of trial
Data sourced from ClinicalTrials.gov (NCT02261974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.