Sexual Function Following Childbirth Clinical Trial
Official title:
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
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.
A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is
planned. This study is designed to demonstrate that the active treatment (i.e., Viveve
Procedure) is superior to the sham treatment for the primary effectiveness and safety
endpoints.
Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active
treatment group or sham group. The active treatment group will receive a treatment dose of 90
J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.
Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post
treatment.
Final data will be reported at 6 months for active and sham treatments.
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