Viveve Medical, a company focused on women's health, has announced positive top-line results from the VIVEVE I clinical study. The VIveve Treatment of the Vaginal Introitus to EValuate Efficacy study is the first randomized, single-blinded and sham-controlled trial designed to demonstrate the efficacy and safety of the Viveve Treatment versus a sham control procedure for the treatment of vaginal introital laxity.
"We are extremely pleased with the final results of the study, which further validate the safety and efficacy of the Viveve Treatment. Equally as significant is the fact that Viveve is the first and only company to have undertaken, and successfully completed, a study of this magnitude for the treatment of vaginal laxity, further establishing us as a leader in this burgeoning area of women's sexual health," said Patricia Scheller, chief executive officer of Viveve. "The Viveve System has already demonstrated a favorable safety and efficacy profile in two previously completed single-arm clinical studies conducted in the U.S. and Japan."
The target population for this study was pre-menopausal females 18 years of age or older who experienced at least one full term vaginal delivery ( >37 completed weeks gestation). Subjects were randomized in a 2:1 ratio to either the active group or sham group. The active group received a target treatment dose of 90 J/cm2 and the sham group received a sub-treatment dose of 1 J/cm2. Subjects had follow-up office visits at 10 days; and 1, 3, and 6 months post-treatment. The efficacy results for the study are based on 155 per protocol subjects from 9 clinical sites in Europe, Canada and Japan. The per protocol population is defined as randomized subjects who received either an active (n=103) or sham treatment (n=52), completed the requisite six month follow-up and did not have a major protocol violation.
The primary endpoint of the study was a comparison of the proportion of women reporting no vaginal laxity in the Viveve treatment group versus the proportion of women reporting no vaginal laxity in the sham group at six months post-treatment. "No vaginal laxity" is defined as a score of greater than 4 on a proprietary, Viveve questionnaire (VSQ).
At 6 months, the proportion of subjects reporting no vaginal laxity in the active group was 41.7% versus the sham group of 19.2% with a Chi-Squared p-value of 0.005.
Subjects receiving the active treatment were three times more likely to report no vaginal laxity at 6 months versus the sham group with a p-value of 0.006 (based on logistic regression).
Mean change from baseline for the active group was 1.9 versus the sham group of 1.1 on the seven point VSQ scale with a p-value of 0.007.
In the population of 174 subjects (117 active, 57 sham) who underwent safety evaluation, the number of reported events was virtually identical between the active and sham groups.
There were zero (0.0%) subjects with a serious adverse event (SAE) in the active group and one (1.8%) in the sham group.