The beta-3 agonist mirabegron has the most evidence for treating overactive bladder (OAB) in men after inefficacy or intolerability of antimuscarinic therapy at 8 to 12 weeks, according to the authors of a new systematic review published in European Urology. But more research on treatment options for men is clearly needed.
Cosimo De Nunzio, MD, PhD, of Sapienza, University of Rome in Rome, Italy, and colleagues conducted a review of 24 studies focusing on male patients with OAB. In an analysis of 5 randomized clinical trials (RCTs) including 1187 men, mirabegron 50 mg was associated with a significant 0.37 greater reduction in urinary frequency compared with placebo. In 3 RCTs of 1317 men with OAB and benign prostatic hyperplasia taking the alpha 1-blocker tamsulosin, the addition of mirabegron 50 mg significantly reduced the mean number of daily micturitions per day by 0.27, urgency episodes by 0.50, and total OAB symptom score by 0.66 and significantly increased mean volume voided by 10.76 mL. Mirabegron was generally well-tolerated.
Limited data existed on other pharmacological treatment options. According to Dr De Nunzio’s team, use of phosphodiesterase-5 inhibitors has yielded “encouraging” results but use of these medications for OAB is still investigational.
Intradetrusor onabotulinumtoxinA appears effective as third-line treatment, according to 3 retrospective and 1 prospective studies of men as well as other research, the investigators reported. The authors noted that risks for acute urinary retention and requiring clean intermittent self-catheterization remain a concern, and the risks are greater in men, especially those without prior prostatic surgery. Bladder voiding efficiency should be taken into account when considering dosage and use, they stated. The team suggested that future studies investigate predictors of successful treatment, risk factors for complications, and efficacy in patients with concomitant benign prostatic obstruction.
In trials of posterior tibial nerve stimulation and sacral nerve stimulation, men made up only 10% of the total study population, precluding assessment of the therapies’ relative risks and benefits.
“Few possible targets for medical therapy in male OAB patients are currently under investigation,” Dr De Nunzio’s team pointed out. Data on urodynamic patterns and combinations of pharmacological or interventional treatment are lacking.
“Long-term data are needed for all options,” the investigators wrote. “Identifying possible prognostic factors for efficacy and treatment failure, cost analysis, and comparative/head-to-head evaluation should be investigated. Data on patients’ ‘impression of improvement’ and patients’ reported outcomes are lacking in men, and these could play an important role in clinical practice.”
In an accompanying editorial, Adrian Wagg, MB BS, of the University of Alberta in Edmonton, Canada, commented that the review “is not only of immediate utility, in that available data are brought together, allowing clinicians to consider ‘next steps’ for eligible men, but also serves as a call to action. We cannot assume that men respond to OAB treatments in a similar fashion to women and we see here that the data on which clinical decisions are made are sadly deficient. More targeted research, such as what we have recently seen concentrating on older adults, is clearly needed.”
With respect to patient preferences, investigators led by Kari A.O. Tikkinen, MD, PhD, of the University of Helsinki in Helsinki, Finland, conducted a separate review of 29 studies, published in European Urology, including 9235 men with lower urinary tract symptoms. Dr Tikkinen’s team found that most men accepted urodynamic testing and preferred less risky treatment options as long as their symptoms were not severe. In addition, men preferred pharmacological treatments with low risks for erectile dysfunction, acute urinary retention, or surgery, and treatments improving urgency incontinence and nocturia.
Disclosure: Several study and editorial authors declared affiliations with the pharmaceutical industry. Please see the original references for a full list of authors’ disclosures.
De Nunzio C, Brucker B, Bschleipfer T, et al. Beyond antimuscarinics: a review of pharmacological and interventional options for overactive bladder management in men. Published online January 2, 2021. Eur Urol. doi:10.1016/j.eururo.2020.12.032
Wagg A. Male overactive bladder: underappreciated, under-researched. More please? Published online January 19, 2021. Eur Urol. doi:10.1016/j.eururo.2021.01.004
Malde S, Umbach R, Wheeler JR, et al. A systematic review of patients’ values, preferences, and expectations for the diagnosis and treatment of male lower urinary tract symptoms. Published online January 15, 2021. Eur Urol. doi:10.1016/j.eururo.2020.12.019