Re: Spontaneous Voiding is Surprisingly Recoverable via Outlet Procedure in Men with Underactive Bladder and Documented Detrusor Underactivity on Urodynamics
Abstract
available at https://pubmed.ncbi.nlm.nih.gov/31635815 Editorial Comment: This article analyzes pooled data from 10 phase 2 to 4, double-blind, 12-week mirabegron monotherapy studies in adults with overactive bladder who received 1 or more doses of study drug. Interventions also included solifenacin and tolterodine. There were no previously unreported safety concerns identified. Improvements in efficacy were observed in all treatment groups. The authors conclude that the data “reaffirm the safety and efficacy profiles of mirabegron, solifenacin and tolterodine in adults of different age groups and sexes.” The study included 11,261 patients (3,018 receiving placebo, 5,244 receiving mirabegron and 2,999 receiving antimuscarinics). The authors cite dry mouth as occurring in 8.7% of the antimuscarinic group, 2.7% of the mirabegron group and 2.4% of the placebo group (severity not specified). Constipation occurred in 2.4%, 2.1% and 1.7% of the patients, treatment emergent hypertension in 3.2%, 3.9% and 3.9%, and tachycardia in 0.5%, 0.9% and 0.5%, respectively. Although assessing combined big data without subdivisions and modifiers can be hazardous, one can get an idea of the relative efficacy by taking the absolute difference between baseline mean and end of treatment mean, and calculating percent change. Incontinence episodes were decreased in 39% of those taking placebo, 54% taking 25 mg mirabegron, 56% taking 50 mg mirabegron, 63% taking 5 mg solifenacin and 48% taking 4 mg…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 11,261 participants or records.
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