Home-use ultrasound a promising nonhormonal treatment option for vaginal dryness

A home-use, therapeutic ultrasound device appears to be safe and perform well for treating vaginal dryness, with efficacy maintained for up to 1 year, as shown in the results of a pilot study.

The double-blind study included postmenopausal women with self-reported vaginal dryness. They were randomly assigned to undergo either ultrasound  (n=21) or sham (n=21) treatment for 12 weeks. After 12 weeks, all participants received open-label ultrasound treatment to 1 year.

Changes in Vaginal Assessment Scale symptoms (dryness, soreness, irritation, dyspareunia) from baseline to week 12 were assessed as the primary efficacy endpoint. The secondary endpoint was scoring of clinician-reported Vaginal Health Index (elasticity, fluid, pH, mucosa, moisture). Safety was also assessed by recording treatment-emergent adverse events.

In the modified intent-to-treat population, the participants in the ultrasound group than in the sham group showed a slightly greater mean reduction in Vaginal Assessment Scale (n=15 in both groups; −0.5 vs −0.4; p=0.9) and a significant improvement in Vaginal Health Index (n=9 in both groups; 2.7 vs 0.6; p=0.3).

In the per-protocol analysis population, ultrasound treatment (n=9) was superior to sham (n=8) both in reducing symptoms score (−0.6 vs −0.0; p=0.4) and improving Vaginal Health Index (2.7 vs −0.4; p=0.03). The improvements in efficacy endpoints were sustained at the 1-year follow-up.

There were no differences observed in treatment-emergent adverse events between the ultrasound group and the sham group. Furthermore, none of the participants experienced serious adverse events.