Reviews assessing mirabegron's safety and efficacy, synthesize data from both genders, without providing specific details for female patients with OAB. The aim of this study is to qualitatively and quantitatively synthesize data evaluating mirabegron's use on female patients with OAB. PubMed/Scopus/Cochrane library/Web of Knowledge were searched for full texted, published in English-language and in peer-reviewed journals, up to November 2019, using the keyword "mirabegron".Jadad score modified by adding allocation concealment, MINORS and RoB were used for the Methodological quality and risk of bias assessment. Twenty-one studies were included in this review;7 RCTs, 3 non-RCTs and 11 observational studies. Controlled trials were of unclear (75%), high (12.5%) or serious risk (12.5%) of bias. Twelve weeks of mirabegron use resulted in significant decrease of urgency, frequency, nocturia and UUI by 1.3-2.2,2.04-2.33,0.42-0.5 and 0.9-1.04 episodes/24 h, respectively. Quality of life and sexual health was improved significantly. Sexual dysfunction decreased from 98% (84/85) at baseline, to 60% (51/85) after 12-weeks of mirabegron (p-value < 0.001). Mirabegron had the same efficacy as anticholinergics in improving all OAB symptoms but with fewer adverse events. Hypertension and antimuscarinics' effects (i.e dry mouth, constipation) had an incidence of 2% (28/1221) and 1.9% (23/1221) when mirabegron was administered, respectively. Mirabegron is a safe and effective alternative therapy for females with OAB. However, there is a paucity of high-quality RCTs, with large sample sizes, long-term follow-up focusing on mirabegron's comparison to other therapies, quality of life and sexual health of female patients with OAB.
European journal of obstetrics, gynecology, and reproductive biology. 2020 May 15 [Epub ahead of print]
Stavros Athanasiou, Eleni Pitsouni, Themos Grigoriadis, Dimitris Zacharakis, Stefano Salvatore, Maurizio Serati
Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, "Alexandra" Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ., Urogynaecology Unit, 1st Department of Obstetrics and Gynecology, "Alexandra" Hospital, National and Kapodistrian University of Athens, Greece., Obstetrics and Gynecology Unit, Vita-Salute San Raffaele University, IRCCS San Raffaele Hospital, Milan, Italy., Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy.