Is the Addition of CO2 Laser to β3-Adrenoceptor Agonist Mirabegron Effective in the Management of Overactive Bladder? Results of a Randomized Controlled Trial

<i>Background and Objectives</i>: 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. <i>Materials and Methods</i>: 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). <i>Results</i>: 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. <i>Conclusions</i>: 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.