A Study Protocol of Micro-Ablative Fractional CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome.

INTRODUCTION: This is a presentation of a study protocol in order to evaluate whether the application of CO2 laser can additionally benefit the improvement of the symptoms of overactive bladder in postmenopausal women who have just started mirabegron as a treatment. MATERIALS AND METHODS: This is a study protocol of a randomized double-blind placebo-controlled trial. A total of 50 menopausal women will participate in the study. All patients will start treatment with mirabegron 50 mg and will be randomized into two groups. Women in group A (control) will undergo CO2 laser treatments while those in group B (placebo group) will receive placebo CO2 laser treatments. In total, three monthly sessions will be held in both groups. The monitoring and evaluation of the results will be carried out by completing a three-day urination diary, as well as by completing the Female Lower Urinary Tract Symptoms, Overactive Bladder Questionnaire, King's Health Questionnaire, Urinary Distress Inventory, Pelvic Floor Impact Questionnaire, Patient Global Impression of Improvement, before each session and a month after the last one. Differences between groups will be assessed at baseline and every month following the three laser therapies. RESULTS: This is an ongoing study protocol, and we are expecting the analysis of the results in 2024. CONCLUSIONS: The use of laser CO2 in postmenopausal women with overactive bladder syndrome may be a well-tolerated alternative treatment. The goal of our study is to evaluate the efficacy of laser treatment in combination with b3-adrenoreceptor agonist therapy.