Effect of Oral Mirabegron on Catheter-Related Bladder Dysfunction After Elective Gynecological Surgery Under General Anesthesia: A Randomized, Placebo-Controlled, Double-Blind Study.

Abstract

Introduction and hypothesis: Mirabegron, an oral β-3 adrenoreceptor agonist, is used to treat overactive bladder symptoms. We investigated the effect of preoperative oral mirabegron on postoperative catheter-related bladder dysfunction (CRBD) in elective gynecological surgeries.

Methods: Eighty-eight women aged 18-65 years with American Society of Anesthesiologists physical status I-III were randomly assigned to receive either oral mirabegron (50-mg tablets) or a placebo 24 h and 1 h before surgery. The primary objective was the difference in the incidence of CRBD on a four-point scale at 1 h. Secondary objectives included differences in CRBD incidence at 0 h, 2 h, and 6 h; severity of CRBD at all time points; postoperative pain; analgesic usage; patient satisfaction; and adverse events.

Results: The mirabegron group had a significantly lower incidence of CRBD (grades 2-4) at 1 h (43.2% vs 72.7%; p 0.009). CRBD incidence was also lower at 0 h (34.1% vs 61.4%; p 0.01) and 2 h (45.5% vs 75%; p 0.005), but comparable at 6 h. Severity of CRBD (grades 3-4) was lower in the mirabegron group at 1 h (6.8% vs 22.7%; p 0.035) and 2 h (0% vs 13.6%; p 0.04), but comparable at 0 h and 6 h. Rescue tramadol was lower in the mirabegron group (p 0.04). Mirabegron did not cause any significant adverse effects such as tachycardia or hypertension. There were no differences in other secondary outcomes.

Conclusions: Two doses of oral mirabegron 50-mg tablets administered 24 h and 1 h before elective gynecological surgery reduced the incidence and severity of early CRBD.