VIVEVE IVIveve Treatment of the Vaginal Introitus to EValuate Effectiveness

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.