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Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Review

Systematic Review ARCHIVED May 26, 2016
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Archived: This report is greater than 3 years old. Findings may be used for research purposes, but should not be considered current.


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Structured Abstract


To assess the efficacy, comparative effectiveness, and adverse effects of newer drugs to treat lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).

Data sources

Ovid MEDLINE®, the Cochrane Central Register of Controlled Trials, and Ovid Embase® bibliographic databases; hand searches of references of relevant studies.

Review methods

We searched bibliographic databases through July 2015. Two investigators screened titles and abstracts of search results and full text of relevant references for eligibility. Eligible studies evaluated efficacy and/or harms of one alpha blocker (AB) (silodosin), several antimuscarinics (tolterodine, solifenacin, fesoterodine), one beta-3 adrenoceptor agonist (mirabegron), and several phosphodiesterase type 5 (PDE-5) inhibitors (tadalafil, sildenafil) or combination therapy with one of these medications. They included randomized controlled trials (RCTs) with duration of at least1 month and observational studies for long-term (≥1 year) adverse events. We assessed risk of bias for RCTs, extracted data, pooled data for analysis when appropriate and feasible, and evaluated strength of evidence for comparisons on an outcome-specific basis.


We synthesized evidence from 57 unique RCTs and 5 observational studies. Trials were generally short term (e.g., 12 weeks). Silodosin was more effective than placebo in improving LUTS but was similar to tamsulosin and had more adverse effects, including abnormal ejaculation. Solifenacin/AB combination therapy was better than placebo, but tolterodine/AB, solifenacin/AB, and fesoterodine/AB combination therapy were similar to AB monotherapy, and combination therapy often had more adverse effects. Tadalafil improved LUTS more than placebo but had more adverse effects. Tadalafil and tamsulosin were similar in improving LUTS. We identified trials testing other drugs (mirabegron, oxybutynin, darifenacin, sildenafil, and vardenafil) but found the evidence insufficient to draw conclusions about efficacy, comparative effectiveness, or adverse effects. Evidence was insufficient to assess long-term efficacy, prevention of symptom progression (e.g., acute urinary retention or need for surgical intervention), or adverse effects.


Several drugs newly used for LUTS attributed to BPH, alone or in combination with older AB, showed evidence of efficacy in short-term studies; however, comparative effectiveness for silodosin, fesoterodine/AB combination, and tadalafil showed that outcomes were similar to older AB monotherapy and adverse effects were often higher with the newly used drugs or combination therapies. Evidence on long-term efficacy and adverse effects was insufficient.

Project Timeline

Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Review

Jan 5, 2015
Apr 24, 2015
May 26, 2016
Systematic Review Archived
Page last reviewed December 2019
Page originally created November 2017

Internet Citation: Systematic Review: Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Review. Content last reviewed December 2019. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.

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