Maintenance Laser Treatment for Vaginal Looseness and Sexual Dysfunction: A Double-blinded Randomized Controlled Trial

Abstract

ABSTRACT Background Vaginal looseness and decreased sensation during intercourse is prevalent in up to 30%–55% of premenopausal women. The efficacy and safety of CO2 laser have been demonstrated for these indications; however, the effect is temporary, up to 6–12 months. No studies regarding the efficacy and safety of adjuvant laser treatments have been conducted to date. Aim To evaluate the efficacy and safety of a single maintenance CO2 laser treatment in women with vaginal looseness and a concurrent decline in sexual sensation during intercourse. Methods This prospective double-blinded randomized controlled trial included premenopausal women who experienced significant temporary improvement in symptoms following previous treatment with CO2 laser due to the abovementioned indications. Participants were randomized to either a single CO2 laser treatment or a single sham treatment. Outcomes Treatment efficacy evaluated with the female sexual function index (FSFI) and the vaginal health index (VHI). Results Overall, 119 women were included in the study. Mean VHI and FSFI scores were significantly higher in the study group compared to the control group at three months post-treatment (17.34±1.39 vs 12.86±2.23, P = .023 and 30.93±1.79 vs 25.78±1.87, P = .044, respectively). In the study group, both VHI and FSFI returned to baseline at six months post-treatment. The median rate of sexual intercourse per month was increased in the study group at three months post-treatment (8 vs 4, P = .011), and returned to baseline at six months post-treatment. Clinical implications Maintenance laser treatment provides a temporary non-surgical alternative for women with vaginal looseness and associated sexual dysfunction, though treatment effect seems to be limited to less than 6 months, requiring additional maintenance sessions. Strengths and limitations The strengths of the current study include a randomized-sham controlled design. Furthermore, VHI was used as an objective evaluation tool, in addition to the FSFI, and assessment of the rate of sexual intercourse. The homogeneity and the relatively small sample size of the cohort is a limitation, and calls for caution in interpretation of the results, and the use of CO2 laser treatment in different age groups and populations. Conclusion A single maintenance laser treatment in women who previously underwent successful treatment with laser is an effective, well-tolerated, and safe procedure for treating symptoms of vaginal looseness and sexual dysfunction, though effects are temporary.