Study: Viveve® Improves Vaginal Laxity

The Viveve System improves vaginal laxity when compared with a sham procedure, a new study suggests. 

Top-line results from the VIveve Treatment of the Vaginal Introitus to EValuate Efficacy (VIVEVE 1) show that the procedure is both safe and effective.

Non-invasive vaginal rejuvenation devices represent a growing category, and these procedures continue to increase in popularity.

The Viveve System uses radiofrequency energy to stimulate the body’s collagen formation processes, which leads to increased vaginal tightness and can improve sexual satisfaction, the company states. Vivive is not for sale in the US yet. The system has received regulatory approval in Canada, Europe, Hong Kong, and select countries in Asia; it is available through physician import license in Japan.

The target population for this study was pre-menopausal females aged 18 years 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 6 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 3 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 7 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 0 (0.0%) subjects with a serious adverse event (SAE) in the active group and 1 (1.8%) in the sham group.