The role of overactive bladder (OAB) treatment in women beyond antimuscarinics has been evaluated extensively. Beta-3 agonists, botulinum toxin-A (BTX-A), and nerve stimulation are indicated in these patients. However, data on male patients in this clinical scenario are scarce.
The aim of this systematic review was to evaluate the evidence on treatment options beyond antimuscarinics in men with OAB.
A search of PubMed, EMBASE, Scopus, Web of science, Cochrane Central Register of Controlled Trials, and Cochrane Central Database of Systematic Reviews databases was performed for relevant articles published between January 2000 and October 2020, using the following Medical Subject Headings: "male/man," "LUTS," "overactive bladder," "storage symptoms," "urgency," "nocturia," "incontinence," "beta-3 agonist," "PDE-5 inhibitors," "botulinum toxin," "sacral nerve stimulation/neurostimulation," "percutaneous/transcutaneous tibial nerve stimulation," "PTENS," and "combination therapy." Evidence acquisition was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. PROSPERO registration number is CRD42020201223.
Overall, 24 studies were retrieved. In male OAB, mirabegron (MIRA) is the most intensively investigated pharmacological option. A pooled analysis of five randomized clinical trials (RCTs), including 1187 patients, concluded that MIRA 50 mg was associated with a greater reduction in frequency versus placebo (-0.37, 95% confidence interval [CI]: -0.74, -0.01, p < 0.05). A pooled analysis of three RCTs, including 1317 male patients, has also shown that the addition of MIRA 50 mg in men receiving the α1-blocker tamsulosin improved the mean number of micturitions per day (-0.27, 95% CI: -0.46 to -0.09, p < 0.05), urgency episodes (-0.50, 95% CI: -0.77 to -0.22, p < 0.05), total OAB symptom score (-0.66, 95% CI: -1.00 to -0.38, p < 0.05), and mean volume voided (+10.76 ml, 95% CI: 4.87-16.64, p < 0.05). MIRA treatment is well tolerated in men. Other pharmacological treatment options, such as phosphodiesterase-5 (PDE-5) inhibitors, should be considered investigational. BTX-A seems to be effective as third-line treatment in male OAB patients. A higher rate of intermittent self-catheterization (5-42%) is observed in male than in female patients. Data on nerve stimulation are scarce.
MIRA has the most robust data in terms of safety and efficacy in this patient population. Preliminary data in men suggest that BTX-A is indicated as an interventional treatment. Evidence for PDE-5 inhibitors and nerve stimulation is too limited to provide recommendations. Future studies in this population should aim to better define the best treatment sequence and to identify predictors for treatment response and failure, to determine a therapeutic approach tailored to patients' characteristics.
Overactive bladder is highly prevalent in men. Mirabegron 50 mg is the treatment option supported by the highest level of evidence when antimuscarinics failed. Botulinum toxin A injections seems to be an effective treatment as interventional option. Roles of nerve stimulation and phosphodiesterase inhibitors in male OAB patients are still to be defined.
European urology. 2021 Jan 02 [Epub ahead of print]
Cosimo De Nunzio, Benjamin Brucker, Thomas Bschleipfer, Jean-Nicolas Cornu, Marcus J Drake, Ferdinando Fusco, Stavros Gravas, Matthias Oelke, Benoit Peyronnet, Manuela Tutolo, Gommert van Koeveringe, Stephan Madersbacher
Urology Unit, Ospedale Sant'Andrea, Sapienza University of Rome, Rome, Italy. Electronic address: ., New York University Langone Health, New York, NY, USA., Clinic for Urology, Andrology and Pediatric Urology, Clinics of Nordoberpfalz AG, Weiden, Germany., Urology Department, Charles Nicolle University Hospital, University of Rouen F-76000, Rouen, France., Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK., Urology Unit, University of Campania L. Vanvitelli, Naples, Italy., Department of Urology, Faculty of Medicine, School of Health Sciences, University of Thessaly, Larissa, Greece., Department of Urology, Pediatric Urology & Urological Oncology, St. Antonius Hospital, Gronau, Germany., Department of Urology, University of Rennes, Rennes, France., Division of Oncology, Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy., Department of Urology, Maastricht University Medical Center, Maastricht, The Netherlands., Department of Urology, Clinic Favoriten and Sigmund Freud Private University, Vienna, Austria.