Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia [entered retrospectively]

Project Summary Title and Description

Title
Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia [entered retrospectively]
Description
Objective. To assess the efficacy, comparative effectiveness, and adverse effects of drugs newly used (last 10 years) within several drug classes (i.e., alpha blockers – silodosin; antimuscarinics - tolterodine, solifenacin, fesoterodine; beta-3 adrenoceptor agonists – mirabegron; phosphodiesterase type 5 (PDE-5) inhibitors - tadalafil, sildenafil) to treat lower urinary tract symptoms attributed to 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 from earliest electronic indexing through March 2015. Two investigators screened titles and abstracts of search results and full-text of relevant references for eligibility. Eligible studies included randomized controlled trials (RCTs) and long-term (>1 year duration) observational studies for long-term adverse effects. We assessed risk of bias for RCTs, extracted data, pooled data for analysis when appropriate and feasible and evaluated strength of evidence for comparisons and outcomes. Results. We searched bibliographic databases through July 2015 for studies testing specific drugs or combinations that included newly used drugs. We synthesized evidence from 57 unique trials and 7 observational studies. All trials lasted less than 3 months. Silodosin was more effective than placebo in improving LUTS, but was similar to tamsulosin, and there were more adverse effects with silodosin, including abnormal ejaculation. Solifenacin/alpha blocker (AB) combination therapy was better than placebo, but tolterodine/AB, solifenacin/AB, and fesoterodine/AB combination therapy were similar to AB monotherapy, and there was often evidence of higher adverse effects with combination therapy. Tadalafil improved LUTS more than placebo but had more adverse effects. Traditional ABs achieved better or similar outcomes than tadalafil; most evidence on comparative adverse effects was insufficient. 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 on long-term effectiveness, other relevant outcomes (prevention of symptom progression, acute urinary retention or need for surgical intervention) or adverse effects. Conclusions. Several drugs newly used, along or in combination with traditional drugs, to treat LUTS attributed to BPH show some evidence of short-term symptom efficacy when compared to placebo. However, outcomes are similar to traditional alpha-blocker therapy and adverse effects are often higher with the newly used drugs or combination therapies. Data were not available to assess long-term maintenance, prevention of disease progression (including acute urinary retention or need for surgical intervention), and adverse effects.
Attribution
N/A
Authors of Report
N/A
Methodology description
N/A
PROSPERO
N/A
DOI
10.7301/Z0ZW1HVH
Notes
Web address not yet available. Data entered retrospectively. Word tables contain basic study information, population characteristics, and risk of bias assessments for included studies.
Funding Source
AHRQ

Key Questions

1. What is the efficacy and comparative effectiveness of newer medications alone or in combination for LUTS attributed to BPH?
2. What are the harms and comparative harms of newer medications for LUTS attributed to BPH?
3. Do the comparative benefits and harms of newer medications for LUTS attributed to BPH differ according to demographic or clinical characteristics?

Associated Extraction Forms

Associated Studies (each link opens a new tab)

TitleAuthorsYear
Non-inferiority of silodosin 4 mg once daily to twice daily for storage symptoms score evaluated by the International Prostate Symptom Score in Japanese patients with benign prostatic hyperplasia: a multicenter, randomized, parallel-group study.2015
Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: a randomized controlled trial.-- Not Found --
Safety and efficacy of 8-mg once-daily vs 4-mg twice-daily silodosin in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (SILVER Study): a 12-week, double-blind, randomized, parallel, multicenter study.2014
Non-inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).2011
Effects of three types of alpha-1 adrenoceptor blocker on lower urinary tract symptoms and sexual function in males with benign prostatic hyperplasia.2011
A randomized crossover study comparing patient preference for tamsulosin and silodosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.
Silodosin therapy for lower urinary tract symptoms in men with suspected benign prostatic hyperplasia: results of an international, randomized, double-blind, placebo- and active-controlled clinical trial performed in Europe.2011
Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia.2010
Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies.2009
Silodosin, a new alpha1A-adrenoceptor-selective antagonist for treating benign prostatic hyperplasia: results of a phase III randomized, placebo-controlled, double-blind study in Japanese men.2006
'Tamsulosin and Darifenacin' Versus 'Tamsulosin Monotherapy' for 'BPH with Accompanying Overactive Bladder'.2015
How to choose first-line treatment for men with predominant storage lower urinary tract symptoms: a prospective randomised comparative study.2015
Effects of initial combined tamsulosin and solifenacin therapy for overactive bladder and bladder outlet obstruction secondary to benign prostatic hyperplasia: a prospective, randomized, multicenter study.2014
Effect of improvement in lower urinary tract symptoms on sexual function in men: tamsulosin monotherapy vs. combination therapy of tamsulosin and solifenacin.2014
Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN).2013
Combination therapy with solifenacin and tamsulosin oral controlled absorption system in a single tablet for lower urinary tract symptoms in men: efficacy and safety results from the randomised controlled NEPTUNE trial.2013
Lower urinary tract symptoms associated with benign prostatic hyperplasia: combined treatment with fesoterodine fumarate extended-release and tamsulosin--a prospective study.2013
Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial.2013
Solifenacin as add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms--ASSIST, randomized controlled study.2011
Impact of lower urinary tract symptoms/benign prostatic hyperplasia treatment with tamsulosin and solifenacin combination therapy on erectile function.2011
Initial combined treatment with anticholinergics and α-blockers for men with lower urinary tract symptoms related to BPH and overactive bladder: a prospective, randomized, multi-center, double-blind, placebo-controlled study.2011
Add-on fesoterodine for residual storage symptoms suggestive of overactive bladder in men receiving α-blocker treatment for lower urinary tract symptoms.2012
The efficacy of additive tolterodine extended release for 1-year in older men with storage symptoms and clinical benign proastatic hyperplasia.
Safety and tolerability of solifenacin add-on therapy to alpha-blocker treated men with residual urgency and frequency.2009
Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers.2009
Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: randomized, double-blind, placebo-controlled study.2008
Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial.2006
A randomized controlled study of the efficacy of tamsulosin monotherapy and its combination with mirabegron for overactive bladder induced by benign prostatic obstruction.2015
Urodynamics and safety of the β₃-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction.2013
Tadalafil 5 mg once-daily therapy for men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results from a randomized, double-blind, placebo-controlled trial carried out in Japan and Korea.2014
A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia.2014
Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia.2014
Tadalafil once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a randomized placebo- and tamsulosin-controlled 12-week study in Asian men.2013
Urodynamic effects of the combination of tamsulosin and daily tadalafil in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, placebo-controlled clinical trial.2013
Evaluation of the effect of sildenafil and/or doxazosin on Benign prostatic hyperplasia-related lower urinary tract symptoms and erectile dysfunction.2013
Efficacy of alfuzosin and sildenafil combination in male patients with lower urinary tract symptoms.2012
Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial.2012
Evaluation of Tadalafil effect on lower urinary tract symptoms of benign prostatic hyperplasia in patients treated with standard medication.-- Not Found --
Hemodynamic effects of once-daily tadalafil in men with signs and symptoms of benign prostatic hyperplasia on concomitant α1-adrenergic antagonist therapy: results of a multicenter randomized, double-blind, placebo-controlled trial.2012
A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.2012
Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study.2012
Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial.2011
Sildenafil citrate and tamsulosin combination is not superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction.2010
Urodynamic effects of once daily tadalafil in men with lower urinary tract symptoms secondary to clinical benign prostatic hyperplasia: a randomized, placebo controlled 12-week clinical trial.2010
Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: an integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report.2009
A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.2008
Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study.2008
Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia.2007
Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial.2007
Combination of alfuzosin and sildenafil is superior to monotherapy in treating lower urinary tract symptoms and erectile dysfunction.2007
Comparison of Two Different α1-Adrenoceptor Antagonists, Tamsulosin and Silodosin, in the Treatment of Male Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A Prospective Randomized Crossover Study2012
Efficacy of Alfuzosin with or without Tolterodine, in men with Benign Prostatic Hyperplasia (BPH) having irritative (overactive bladder) symptoms.2014
Additive role of trospium chloride in the management of men with voiding and storage symptoms.2012
The Comparison α-Blocker+M3 Selective Anti-Muscarinic Combined Therapy and α-Blocker Monotherapy 2012
Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia2014
Tadalafil for the Treatment of Lower Urinary Tract Symptoms in Japanese Men with Benign Prostatic Hyperplasia: Results from a 12-week Placebo-controlled Dose-finding Study with a 42-week Open-label Extension2012
Tadalafil Administered Once Daily for Treatment of Lower Urinary Tract Symptoms in Korean men with Benign Prostatic Hyperplasia: Results from a Placebo-Controlled Pilot Study Using Tamsulosin as an Active Control2011

Downloadable Data Content

Files
  • XLSX Project Data