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Cover of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostaic Hyperplasia: A Review

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

Comparative Effectiveness Reviews, No. 178

Investigators: , PhD, MSPH, MLIS, , MS, , MD, MHSc, , MD, MS, , MSc, , MD, MPH, , MD, PhD, , MBChB, MPH, MHA, and , MD, MPH.

Author Information
Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 16-EHC024-EF

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.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1 . Contract No. 290-2012-00161-I. Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN

Suggested citation:

Brasure M, MacDonald R, Dahm P, Olson CM, Nelson VA, Fink HA, Risk M, Rwabasonga B, Wilt TJ. Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Review. Comparative Effectiveness Review No. 178. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00161-I.) AHRQ Publication No. 16-EHC024-EF. Rockville, MD: Agency for Healthcare Research and Quality; May 2016.

This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00161-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.

This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at Search on the title of the report.


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Bookshelf ID: NBK368444PMID: 27336104


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