Laser Treatment Study for Women with Vulvodynia Evaluating Effectiveness and Safety of Vulvovaginal Laser Therapy

What this Trial Is About

This research aims to evaluate the effectiveness, acceptance, and safety of vulvovaginal laser therapy in women diagnosed with vulvodynia. The study is a randomized, double-blinded, sham-controlled clinical trial designed to compare laser therapy with sham laser therapy in reducing vulvar pain, assessed by tests such as the Q-tip and tampon tests. Secondary goals include measuring improvements in sexual health, quality of life, and side effect rates between the two groups. Participants are randomly assigned to one of two groups the active laser therapy group or the sham laser therapy group. Those in the laser therapy group will receive two treatments over three months using a non-ablative 2940 nm ErYAG laser according to a standardized protocol. The control group will receive two sham treatments using the same procedures but with a placebo probe that blocks laser emission, ensuring no therapeutic radiation is delivered. During the study, participants will undergo assessments at baseline and after three months to measure changes in vestibular pain, pelvic floor muscle function, levator hiatal dimensions, vaginal health, sexual activity and function, and various health and pain questionnaires. Treatment discomfort and pain will also be evaluated twice after treatment. The study includes safety monitoring and patient satisfaction evaluations throughout the treatment period.

Lasertherapy for Vulvodynia