Project 451143

Chronic vulvar pain is a highly prevalent and debilitating condition affecting up to 18% of women. The most common subtype of vulvar pain, provoked vestibulodynia (PVD), is characterized by a sharp pain at the entry of the vagina in response to the application of pressure or attempted vaginal penetration. Women with PVD not only present with psychological distress and significant disruption in all aspects of sexual function, but they are also confronted with limited effective treatment options. High-intensity laser could potentially fill this therapeutical void by providing a non-invasive treatment option. Judged by experts as a promising intervention, a recent rise in popularity has compelled leading societies to issue a warning statement to urgently examine the efficacy of laser for gynecological conditions. Therefore, our multidisciplinary team, working together for more than 15 years, has conducted novel research to prepare for the current proposal. For instance, our systematic review underscored the lack of studies and served as a strong basis to select the most optimal laser parameters. Moreover, our randomized pilot study confirmed that our state-of-the-art laser treatment protocol is feasible for treating PVD and the promising findings obtained provide support for conducting a large-scale study. The proposed double-blind randomized controlled trial aims to establish the efficacy of high-intensity laser therapy for reducing pain in women with PVD. Women will be randomized to receive either sham or active Nd:Yag laser treatment for 12 bi-weekly sessions. Validated outcome measures will be assessed at baseline, post-treatment and at 6-month follow-up. The current proposal addresses the urgent need to determine whether women with PVD could benefit from this non-invasive treatment. It will enable women with PVD to be directed to appropriate treatment options and, if proven effective, laser could be proposed as a first-line non-invasive treatment.