Background and Objectives: This study aimed to assess whether the addition of fractional CO2 laser therapy to standard pharmacologic treatment with Mirabegron, a β3-adrenoceptor agonist, enhances the clinical outcomes in the management of overactive bladder syndrome (OAB) in postmenopausal women. Materials and Methods: Τhis was a prospective, randomized, double-blind, sham-controlled trial including 50 postmenopausal women with moderate-to-severe OAB symptoms. Participants were randomized (1:1) to receive mirabegron 50 mg daily in combination with either active fractional CO2 laser therapy (Group A) or sham laser treatment (Group B). Both groups underwent three monthly sessions of vaginal laser treatment and were followed for a total of four months. Clinical assessments were performed at baseline and monthly visits (T0-T3), using validated instruments including the Overactive Bladder Questionnaire (OAB-q), King's Health Questionnaire (KHQ), Urinary Distress Inventory (UDI-6), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), and 3-day voiding diaries. The trial was registered at ClinicalTrials.gov (Identifier: NCT03846895). Results: Significant symptom improvement was observed within both groups over time, with reductions in urinary frequency, urgency, nocturia, and incontinence episodes, as well as improvements in quality-of-life scores. However, intergroup comparisons revealed no statistically significant differences in any primary or secondary outcomes. Both treatment modalities demonstrated similar effectiveness across all measured parameters. Conclusions: In this randomized controlled trial, the adjunctive use of fractional CO2 laser therapy did not offer additional clinical benefit beyond mirabegron monotherapy in the short-term management of OAB. These findings underscore the need for further investigation into tailored therapeutic strategies, particularly in populations with overlapping genitourinary syndrome of menopause or more refractory OAB symptoms.
Medicina (Kaunas, Lithuania). 2025 Jun 30*** epublish ***
Konstantinos Kypriotis, Anastasia Prodromidou, Stavros Athanasiou, Dimitrios Zacharakis, Nikolaos Kathopoulis, Athanasios Douligeris, Veatriki Athanasiou, Lina Michala, Themos Grigoriadis
Urogynecology Unit, 1st Department of Obstetrics and Gynaecology, "Alexandra" General Hospital, National and Kapodistrian University of Athens, 11528 Athens, Greece., Medicine, Brighton and Sussex Medical School, Brighton BN1 9PX, UK.