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Meta-Analysis
. 2017 Nov 22;11(11):CD012615.
doi: 10.1002/14651858.CD012615.pub2.

Silodosin for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia

Jae Hung Jung  1 , Jiye Kim, Roderick MacDonald, Balaji Reddy, Myung Ha Kim, Philipp Dahm
Affiliations
Meta-Analysis

Silodosin for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia

Jae Hung Jung et al. Cochrane Database Syst Rev. .

Abstract

Background: A variety of alpha-blockers are used for treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Silodosin is a novel, more selective alpha-blocker, which is specific to the lower urinary tract and may have fewer side effects than other alpha-blockers.

Objectives: To assess the effects of silodosin for the treatment of LUTS in men with BPH.

Search methods: We performed a comprehensive search using multiple databases (Cochrane Library, MEDLINE, EMBASE, Scopus, Google Scholar, and Web of Science), trials registries, other sources of grey literature, and conference proceedings with no restrictions on the language of publication or publication status up until 13 June 2017.

Selection criteria: We included all parallel, randomized controlled trials. We also included cross-over designs.

Data collection and analysis: Two review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We rated the quality of evidence according to the GRADE approach.

Main results: We included 19 unique studies with 4295 randomized participants across four comparisons for short-term follow-up. The mean age, prostate volume, and International Prostate Symptom Score were 66.5 years, 38.2 mL, and 19.1, respectively. Silodosin versus placeboBased on four studies with a total of 1968 randomized participants, silodosin may reduce urologic symptom scores in an appreciable number of men (mean difference (MD) -2.65, 95% confidence interval (CI) -3.23 to -2.08; low-quality evidence). Silodosin likely does not result in a clinically important reduction in quality of life (MD -0.42, 95% CI -0.71 to -0.13; moderate-quality evidence). It may not increase rates of treatment withdrawal for any reason (relative risk (RR) 1.08, 95% CI 0.70 to 1.66; low-quality evidence). We are uncertain about the effect of silodosin on cardiovascular adverse events (RR 1.28, 95% CI 0.67 to 2.45; very low-quality evidence). Silodosin likely increases sexual adverse events (RR 26.07, 95% CI 12.36 to 54.97; moderate-quality evidence); this would result in 180 more sexual adverse events per 1000 men (95% CI 82 more to 388 more). Silodosin versus tamsulosinBased on 13 studies with a total of 2129 randomized participants, silodosin may result in little to no difference in urologic symptom scores (MD -0.04, 95% CI -1.31 to 1.24; low-quality evidence) and quality of life (MD -0.15, 95% CI -0.53 to 0.22; low-quality evidence). We are uncertain about treatment withdrawals for any reason (RR 1.02, 95% CI 0.62 to 1.69; very low-quality evidence). Silodosin may result in little to no difference in cardiovascular adverse events (RR 0.77, 95% CI 0.53 to 1.12; low-quality evidence). Silodosin likely increases sexual adverse events (RR 6.05, 95% CI 3.55 to 10.31; moderate-quality evidence); this would result in 141 more sexual adverse events per 1000 men (95% CI 71 more to 261 more). Silodosin versus naftopidilBased on five studies with a total of 763 randomized participants, silodosin may result in little to no differences in urologic symptom scores (MD -0.85, 95% CI -2.57 to 0.87; low-quality evidence), quality of life (MD -0.17, 95% CI -0.60 to 0.27; low-quality evidence), treatment withdrawal for any reason (RR 1.25, 95% CI 0.81 to 1.93; low-quality evidence), and cardiovascular adverse events (RR 1.02, 95% CI 0.41 to 2.56; low-quality evidence). Silodosin likely increases sexual adverse events (RR 5.93, 95% CI 2.16 to 16.29; moderate-quality evidence); this would result in 74 more sexual adverse events per 1000 men (95% CI 17 more to 231 more). Silodosin versus alfuzosinBased on two studies with a total of 155 randomized participants, silodosin may or may not result in a clinically important increase in urologic symptom scores (MD 3.83, 95% CI 0.12 to 7.54; low-quality evidence). Silodosin likely results in little to no difference in quality of life (MD 0.14, 95% CI -0.46 to 0.74; moderate-quality evidence). We found no event of treatment withdrawal for any reason. Silodosin may not reduce cardiovascular adverse events (RR 0.67, 95% CI 0.36 to 1.24; low-quality evidence) but likely increases sexual adverse events (RR 37.21, 95% CI 5.32 to 260.07; moderate-quality evidence); this would result in 217 more sexual adverse events per 1000 men (95% CI 26 more to 1000 more).

Authors' conclusions: Silodosin may reduce urologic symptom scores in an appreciable number of men compared to placebo. Quality of life and treatment withdrawals for any reason appears similar. Its efficacy appears similar to that of other alpha blockers (tamsulosin, naftopidil and alfuzosin) but the rate of sexual side effects is likely higher. Our certainty in the estimates of effect was lowered due to study limitations, inconsistency and imprecision.

PubMed Disclaimer

Conflict of interest statement

JHJ: none known

JK: none known

RM: none known

BR: none known

MHK: none known

PD: PD serves as Co‐ordinating Editor of Cochrane Urology. However, he was not involved in the editorial processing or decision‐making for this review. Other editors of Cochrane Urology managed the editorial process, including final sign‐off for this review.

Figures

1
1
Flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1 Silodosin versus placebo, Outcome 1 Urologic symptom scores (short term).
1.2
1.2. Analysis
Comparison 1 Silodosin versus placebo, Outcome 2 Quality of life (short term).
1.3
1.3. Analysis
Comparison 1 Silodosin versus placebo, Outcome 3 Treatment withdrawal due to any reason (short term).
1.4
1.4. Analysis
Comparison 1 Silodosin versus placebo, Outcome 4 Treatment withdrawal due to adverse events (short term).
1.5
1.5. Analysis
Comparison 1 Silodosin versus placebo, Outcome 5 Cardiovascular adverse events (short term).
1.6
1.6. Analysis
Comparison 1 Silodosin versus placebo, Outcome 6 Sexual adverse events (short term).
2.1
2.1. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 1 Urologic symptom scores (short term).
2.2
2.2. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 2 Quality of life (short term).
2.3
2.3. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 3 Treatment withdrawal due to any reason (short term).
2.4
2.4. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 4 Treatment withdrawal due to adverse events (short term).
2.5
2.5. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 5 Cardiovascular adverse events (short term).
2.6
2.6. Analysis
Comparison 2 Silodosin versus tamsulosin, Outcome 6 Sexual adverse events (short term).
3.1
3.1. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 1 Urologic symptom scores (short term).
3.2
3.2. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 2 Quality of life (short term).
3.3
3.3. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 3 Treatment withdrawal due to any reason (short term).
3.4
3.4. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 4 Treatment withdrawal due to adverse events (short term).
3.5
3.5. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 5 Cardiovascular adverse events (short term).
3.6
3.6. Analysis
Comparison 3 Silodosin versus naftopidil, Outcome 6 Sexual adverse events (short term).
4.1
4.1. Analysis
Comparison 4 Silodosin versus alfuzosin, Outcome 1 Urologic symptom scores (short term).
4.2
4.2. Analysis
Comparison 4 Silodosin versus alfuzosin, Outcome 2 Quality of life (short term).
4.3
4.3. Analysis
Comparison 4 Silodosin versus alfuzosin, Outcome 3 Cardiovascular adverse events (short term).
4.4
4.4. Analysis
Comparison 4 Silodosin versus alfuzosin, Outcome 4 Sexual adverse events (short term).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Chapple 2011 {published data only}
    1. Chapple CR, Montorsi F, Desgrandchamps F, Silodosin European Study Group. Efficacy of silodosin as compared with tamsulosin and placebo for the treatment of the signs and symptoms of benign prostatic hyperplasia. a multicentre, randomised, double‐blind, controlled trial. European Urology Supplements 2010;9(2):313. [DOI: ]
    1. Chapple CR, Montorsi F, Tammela TL, Wirth M, Koldewijn E, Fernandez Fernandez E, et al. 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. European Urology 2011;59(3):342‐52. [DOI: 10.1016/j.eururo.2010.10.046; PUBMED: 21109344] - DOI - PubMed
    1. Chapple CR, Montorsi F, Tammela Tl, Wirth M, Koldewijn E, Fernandez Fernandez E. 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. Urologia 2012;5:38‐42, 44‐5. [PUBMED: 23342615] - PubMed
    1. EUCTR2005‐005665‐11‐GB. Evaluation of the efficacy and safety of silodosin vs. Tamsulosin and placebo in the treatment of the signs and symptoms of benign prostatic hyperplasia. Multicentre, randomised, double‐blind, controlled trial with an optional long‐term open‐label extension phase. apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2005‐005665‐11‐GB (date first received 10 October 2017).
    1. NCT00359905. Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH. https://clinicaltrials.gov/ct2/show/NCT00359905?term=NCT00359905&rank=1 (date first received 10 October 2017).
Jung 2012 {published data only}
    1. Jung GW, Park SJ, Seo J. Effect of short‐term treatment with silodosin on ejaculatory function in sexually active men with benign prostate hyperplasia. Journal of Urology 2012; Vol. 187, issue 4 Supplement:e511. [DOI: ]
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Kawabe 2006a {published data only}
    1. Kawabe K, Yoshida M, Homma Y, Silodosin Clinical Study Group. 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. BJU International 2006;98(5):1019‐24. [DOI: 10.1111/j.1464-410X.2006.06448.x; PUBMED: 16945121] - DOI - PubMed
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Manjunatha 2016a {published data only}
    1. CTRI/2013/07/003805. A clinical study of the effects of the three licensed drugs alfuzosin, tamsulosin and silodosin in patients with benign prostatic hyperplasia, a disease predominantly causing urinary problems in aging men. apps.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2013/07/003805 (date first received 01 September 2017).
    1. Manjunatha R, Pundarikaksha HP, Madhusudhana HR, Amarkumar J, Hanumantharaju BK. A randomized, comparative, open‐label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia. Indian Journal of Pharmacology 2016; Vol. 48, issue 2:134‐40. [DOI: 10.4103/0253-7613.178825; PUBMED: 27127315] - DOI - PMC - PubMed
Marks 2009 {published data only}
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    1. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α1A‐adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. Journal of Urology 2009;181(6):2634‐40. [DOI: 10.1016/j.juro.2009.02.034; PUBMED: 19371887] - DOI - PubMed
    1. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α1A‐adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. Journal of Urology 2013;189(1 Suppl):S122‐8. [DOI: http://dx.doi.org/10.1016/j.juro.2012.11.020] - PubMed
    1. Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid response of irritative and obstructive urinary symptoms of benign prostatic hyperplasia to treatment with silodosin in 2 randomized studies. Journal of Urology 2009;181(4):694. [DOI: ]
    1. NCT00224107. A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo. clinicaltrials.gov/ct2/show/NCT00224107?term=NCT00224107&rank=1 (date first received 10 October 2017).
Masuda 2012 {published data only}
    1. Masuda M, Jinza S, Masuko H, Asakura T, Hashiba T. Comparison of naftopidil and silodosin in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, crossover study. Acta Urologica Japonica 2012;58(12):671‐8. [PUBMED: 23328162] - PubMed
Matsukawa 2016 {published data only}
    1. Matsukawa Y, Funahashi Y, Takai S, Majima T, Ogawa T, Narita H, et al. Comparison of silodosin and naftopidil for efficacy in the treatment of benign prostatic enlargement complicated by overactive bladder: a randomized, prospective study (SNIPER study). Journal of Urology 2017;197(2):452‐8. [DOI: 10.1016/j.juro.2016.08.111; PUBMED: 27615436] - DOI - PubMed
Miyakita 2010 {published data only}
    1. Miyakita H, Yokoyama E, Onodera Y, Utsunomiya T, Tokunaga M, Tojo T, et al. Short‐term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia. International Journal of Urology 2010;17(10):869‐75. [DOI: ] - PubMed
Natarajan 2015 {published data only}
    1. Natarajan B, Kalra Y. Silodosin versus tamsulosin in symptomatic benign prostatic hyperplasia‐Our experience. Journal Of Pharmacy 2015;5(6):8‐10. [DOI: 10.9790/XXXXXXXXX] - DOI
NCT00793819 {unpublished data only}
    1. NCT00793819. A double‐blind, placebo‐controlled phase 2 study of silodosin 8 mg daily for the treatment of nocturia in men with benign prostatic hyperplasia. clinicaltrials.gov/ct2/show/NCT00793819?term=NCT00793819&rank=1 (date first received 01 September 2017).
Pande 2014 {published data only}
    1. CTRI/2014/01/004366. Evaluation of the effectiveness and safety of silodosin in comparison to tamsulosin in benign prostatic hyperplasia. ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=7666&EncHid=&amp... (date first received 10 October 2017).
    1. Pande S, Hazra A, Kundu AK. Evaluation of silodosin in comparison to tamsulosin in benign prostatic hyperplasia: a randomized controlled trial. Indian Journal of Pharmacology 2014;46(6):601‐7. [DOI: 10.4103/0253-7613.144912] - DOI - PMC - PubMed
Shirakawa 2013 {published data only}
    1. JPRN‐UMIN000008331. A comparative study on the clinical effects of silodosin and naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000008331 (date first received 10 October 2017).
    1. Shirakawa T, Haraguchi T, Matsumoto M, Morishita S, Minayoshi K, Miyazaki J, et al. A comparative study on the clinical effects of silodosin and naftopidil in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. Urology 2010;76(3 Supplement):S106.
    1. Shirakawa T, Haraguchi T, Matsumoto Y, Takeda M, Morishita S, Minayoshi K, et al. A comparative study on the clinical effects of silodosin and naftopidil in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. International Urogynecology Journal and Pelvic Floor Dysfunction 2011;22:S1209.
    1. Shirakawa T, Haraguchi T, Matsumoto Y, Takeda M, Morishita S, Minayoshi K, et al. A comparative study on the clinical effects of silodosin and naftopidil in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (abstract number 887). Joint Meeting of the International Continence Society (ICS) and the International Urogynecological Association. 2010:23‐27.
    1. Shirakawa T, Haraguchi T, Shigemura K, Morishita S, Minayoshi K, Miyazaki J, et al. Silodosin versus naftopidil in Japanese patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized multicenter study. International Journal of Urology 2013; Vol. 20, issue 9:903‐10. [DOI: 10.1111/iju.12055; PUBMED: 23252453] - DOI - PubMed
Takeshita 2016 {published data only}
    1. JPRN‐UMIN000004918. Silodosin 4mg versus tamsulosin 0.2mg once daily; randomized crossover study. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000004918 (date first received 25 October 2017).
    1. Takeshita H, Moriyama S, Arai Y, Washino S, Saito K, Chiba K, et al. Randomized crossover comparison of the short‐term efficacy and safety of single half‐dose silodosin and tamsulosin hydrochloride in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. LUTS: Lower Urinary Tract Symptoms 2016;8(1):38‐43. [DOI: 10.1111/luts.12106] - DOI - PubMed
Watanabe 2011 {published data only}
    1. Watanabe T, Ozono S, Kageyama S. A randomized crossover study comparing patient preference for tamsulosin and silodosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. Journal of International Medical Research 2011;39(1):129‐42. [PUBMED: 21672315 ] - PubMed
    1. Watanabe T, Ozono S, Kageyama S. Erratum to A randomized crossover study comparing patient preference for tamsulosin and silodosin in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (J Int Med Res 2011;39:129‐42). Journal of International Medical Research 2011;39(3):1122. - PubMed
Yamaguchi 2013 {published data only}
    1. Takahashi S, Yamaguchi K. Treatment of benign prostatic hyperplasia and aging: impacts of alpha‐1 blockers on sexual function. Journal of Men's Health 2011;8(Supplement 1):S25‐8.
    1. Yamaguchi K, Aoki Y, Yoshikawa T, Hachiya T, Saito T, Takahashi S. Silodosin versus naftopidil for the treatment of benign prostatic hyperplasia: a multicenter randomized trial. International Journal of Urology 2013;20(12):1234‐8. [DOI: 10.1111/iju.12160; PUBMED: 23731168] - DOI - PubMed
Yamanishi 2011 {published data only}
    1. Yamanishi T, Sakakibara R, Uchiyama T. Comparison of the effects of silodosin and tamsulosin for the treatment of benign prostatic hyperplasia (Abstract number 290). 41st Annual Meeting of the International Continence Society. 2011.
Yokoyama 2011 {published data only}
    1. Yokoyama T, Hara R, Fukumoto K, Fujii T, Jo Y, Miyaji Y, et al. Effects of three types of alpha‐1 adrenoceptor blocker on lower urinary tract symptoms and sexual function in males with benign prostatic hyperplasia. International Journal of Urology 2011;18(3):225‐30. [DOI: 10.1111/j.1442-2042.2010.02708.x; PUBMED: 21272091] - DOI - PubMed
Yokoyama 2012 {published data only}
    1. Yokoyama T, Fukumoto K, Hara R, Fujii T, Jo Y, Miyaji Y, et al. Comparison of different a1‐adrenoceptor antagonists, tamsulosin hydrochloride and silodosin for treatment of male lower urinary tract symptoms: a prospective randomized crossover study. International Journal of Urology 2011;18(5):404. [DOI: 10.1111/j.1442-2042.2011.02758.x] - DOI
    1. Yokoyama T, Hara R, Fujii T, Jo Y, Miyaji Y, Nagai A. 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 study. LUTS: Lower Urinary Tract Symptoms 2012;4(1):14‐8. [DOI: 10.1111/j.1757-5672.2011.00099.x; PUBMED: 26676453] - DOI - PubMed
Yu 2011 {published data only}
    1. Yu HJ, Lin AT, Yang SS, Tsui KH, Wu HC, Cheng CL, et al. Non‐inferiority of silodosin to tamsulosin in treating patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). BJU International 2011;108(11):1843‐8. [DOI: 10.1111/j.1464-410X.2011.10233.x; PUBMED: 21592295 ] - DOI - PubMed

References to studies excluded from this review

Abramowicz 2009 {published data only}
    1. Abramowicz M, Zuccotti G, Pflomm JM, Daron SM, Houst BM, Zanone CE, et al. Silodosin (Rapaflo) for benign prostatic hyperplasia. Medical Letter on Drugs and Therapeutics 2009;51(1303):3‐4. - PubMed
Alcántara Montero 2016 {published data only}
    1. Alcántara Montero A. Silodosin in the treatment of lower urinary tract symptoms due to benign prostatic hyperplasia: The standard approach and «real life» use [Silodosina en el tratamiento de los síntomas del tracto urinario inferior en el varón por hiperplasia benigna de próstata: enfoque estándar y uso en la «vida real»]. Revista Mexicana de Urología 2016;76(6):352‐9. [DOI: 10.1016/j.uromx.2016.09.005] - DOI
    1. Alcántara Montero A. The role of alpha blockers in the treatment of lower urinary tract symptoms/benign prostatic hyperplasia: are all the same? Silodosin in "real life". Semergen 2016;42 Suppl 2:1‐9. [DOI: 10.1016/S1138-3593(16)30245-3; PUBMED: 27889014 ] - DOI - PubMed
Araki 2013 {published data only}
    1. Araki T, Monden K, Araki M. Comparison of 7 α1‐adrenoceptor antagonists in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a short‐term crossover study. Acta Medica Okayama 2013;67(4):245‐51. [PUBMED: 23970323] - PubMed
Boeri 2016 {published data only}
    1. Boeri L, Capogrosso P, Ventimiglia E, Croce G, Moretti D, Scano R, et al. Clinically meaningful improvements in LUTS/BPH severity in men treated with silodosin plus Serenoa repens or silodosin alone. Journal of Urology 2016;195(4):e464. [DOI: ] - PMC - PubMed
Cakiroglu 2016 {published data only}
    1. Cakiroglu B, Hazar İ, Sinanoglu O, Arda E, Ekici S. Comparison of transurethral incision and silodosin in LUTS patients in terms of retrograde ejaculation. European Urology Supplements 2016;5(15):e1236. [DOI: 10.1016/S1569-9056(16)15063-8] - DOI
Chapple 2009 {published data only}
    1. Chapple CR, Silodosin European Study Group. Silodosin: a new α‐adrenoceptor antagonist highly selective for the lower urinary tract. European Urology Supplements 2009;8(4):238. [DOI: ]
Curran 2011 {published data only}
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JPRN‐UMIN000007917 {unpublished data only}
    1. JPRN‐UMIN000007917. Efficacy of silodosin in benign prostatic hyperplasia with overactive bladder. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000007917 (date first received 01 September 2017).
Kawabe 2006b {published data only}
    1. Kawabe K, Yoshida M, Arakawa S, Takeuchi H. Long‐term evaluation of silodosin, a new α1A‐adrenoceptor selective antagonist for the treatment of benign prostatic hyperplasia: phase III long‐term study. Japanese Journal of Urological Surgery 2006;19:153‐64.
Kobayashi 2008 {published data only}
    1. Kobayashi K, Masumori N, Hisasue SI, Kato R, Hashimoto K, Itoh N, et al. Inhibition of seminal emission Is the main cause of anejaculation induced by a new highly selective α1A‐Blocker in normal volunteers. Journal of Sexual Medicine 2008;5(9):2185‐90. [DOI: 10.1111/j.1743-6109.2008.00779.x] - DOI - PubMed
Kobayashi 2009 {published data only}
    1. Kobayashi K, Masumori N, Kato R, Hisasue S, Furuya R, Tsukamoto T. Orgasm is preserved regardless of ejaculatory dysfunction with selective alpha 1A‐blocker administration. International Journal of Impotence Research 2009;21(5):306‐10. [DOI: 10.1038/ijir.2009.27] - DOI - PMC - PubMed
Manjunatha 2016b {published data only}
    1. Manjunatha R, Pundarikaksha HP, Madhusudhana HR. A prospective analysis of the cost‐effectiveness of alfuzosin, tamsulosin and silodosin for 12 weeks in benign prostatic hyperplasia. International Journal of Basic & Clinical Pharmacology 2016;5(6):2481‐7. [DOI: 10.18203/2319-2003.ijbcp20164109] - DOI
Matsukawa 2012 {published data only}
    1. Matsukawa Y, Hattori R, Mazima T, Yamamoto T, Yoshino Y, Gotoh M. Is combination therapy with an anticholinergic agent and an alpha1‐adrenoceptor antagonist useful as first‐line treatment in patients with benign prostatic hyperplasia complicated by overactive bladder? A randomized, prospective, comparative study using a urodynamic study. European Urology Supplements 2012;11(1):e753. [DOI: ]
Matsukawa 2017 {published data only}
    1. Matsukawa Y, Takai S, Funahashi Y, Majima T, Kato M, Yamamoto T, et al. Effects of withdrawing alpha‐1 blocker from the combination therapy with alpha‐1 blocker and 5‐alpha‐reductase inhibitor in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective and comparative trial using urodynamics. Journal of Urology 2017 [Epub ahead of print]; Vol. May. [DOI: 10.1016/j.juro.2017.05.031; PUBMED: 28499730 ] - DOI - PubMed
Michel 2011 {published data only}
    1. Michel MC, Casi M, Antonellini A. Silodosin consistently improves nocturia in men with LUTS suggestive of BPH. Analysis of three phase III placebo‐controlled studies. European Urology Supplements 2011;10(2):121‐2. [DOI: ]
Montorsi 2010 {published data only}
    1. Montorsi F. Profile of silodosin. European Urology Supplements 2010;9(4):491‐5. [DOI: 10.1016/j.eursup.2010.04.001] - DOI - PubMed
Montorsi 2013 {published data only}
    1. Montorsi F. Profile of silodosin. Urologiia 2013;2:112‐4, 116‐7. [PUBMED: 23789376 ] - PubMed
Prescrire Int 2011 {published data only}
    1. Prescribe International. Silodosin. Prescrire International 2011;20(118):180. - PubMed
Prescrire Int 2012 {published data only}
    1. Prescribe International. Silodosin: erectile and ejaculatory disorders. Prescrire International 2012; Vol. 21, issue 127:129. - PubMed
Roehrborn 2009 {published data only}
    1. Roehrborn CG, Lepor H, Kaplan SA. Retrograde ejaculation induced by silodosin is the result of relaxation of smooth musculature in the male uro‐genital tracts and is associated with greater urodynamic and symptomatic improvements in men LUTS secondary to BPH. Journal of Urology 2009;181(4):694‐5. [DOI: ]
Yoshida 2017 {published data only}
    1. Yoshida M, Origasa H, Seki N. Comparison of silodosin versus tadalafil in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia. Lower Urinary Tract Symptoms 2017 [Epub ahead of print]; Vol. April. [DOI: 10.1111/luts.12177; 28439987] - DOI - PubMed
Yoshihisa 2012 {published data only}
    1. Yoshihisa M, Ryohei H, Shun T, Tokunori Y, Momokazu G. The effect of combination therapy with an anticholinergic agent and an + 1‐adrenoceptor antagonist in patients with benign prostatic hyperplasia complicated by an overactive bladder: a randomized, prospective, comparative, urodynamic study. International Journal of Urology 2012;19:180. [DOI: 10.1111/j.1442-2042.2012.03167.x] - DOI
Zhou 2011 {published data only}
    1. Zhou Y, Sun PH, Liu YW, Zhao X, Meng L, Cui YM. Safety and pharmacokinetic studies of silodosin, a new alpha(1A)‐adrenoceptor selective antagonist, in healthy Chinese male subjects. Biological and Pharmaceutical Bulletin 2011;34(8):1240‐5. [PUBMED: 21804212 ] - PubMed

References to studies awaiting assessment

CTRI/2010/091/000526 {unpublished data only}
    1. CTRI/2010/091/000526. A clinical trial to study the effects of silodosin in patients with benign prostatic hyperplasia. apps.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2010/091/000526 (date first received 01 September 2017).
Devana 2014 {published data only}
    1. Devana SK, Singh SK, Ravi Mohan SM, Mandal AK. A prospective randomized study on the short term efficacy of three alpha 1 adrenergic blockers in patients with symptomatic benign prostatic hyperplasia. Indian Journal of Urology 2014; Vol. 30:S96.
Jha 2015 {published data only}
    1. Jha SK, Kumar A, Vasudeva P, Kumar R, Singh H, Kumar G. Prospective randomised comparative study of safety and efficacy of silodosin versus tamsulosin in the medical management of benign prostatic enlargement causing lower urinary tract symptoms. Indian Journal of Urology 2015; Vol. 31:S69.
JPRN‐UMIN000003125 {unpublished data only}
    1. JPRN‐UMIN000003125. CLSS‐based assessment of alfa‐adrenoceptor blockers for male LUTS (CLAM‐STUDY). apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000003125 (date first received 01 September 2017).
JPRN‐UMIN000005151 {unpublished data only}
    1. JPRN‐UMIN000005151. The clinical study for evaluating the early efficacy and safety of alpha‐1‐adrenoreceptor antagonists in patient with benign prostatic hyperplasia. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000005151 (date first received 01 September 2017).
JPRN‐UMIN000008538 {unpublished data only}
    1. JPRN‐UMIN000008538. Comparison of the long‐term efficacy of silodosin and tamsulosin for the treatment of benign prostatic hyperplasia. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000008538 (date first received 01 September 2017).
JPRN‐UMIN000011556 {unpublished data only}
    1. JPRN‐UMIN000011556. Comparative study of early efficacy of once‐daily dosing between silodosin 4mg and tamsulosin 0.2mg for voiding symptoms associated with benign prostatic hyperplasia. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000011556 (date first received 01 September 2017).
Mandal 2013 {published data only}
    1. Mandal A, Devana S, Singh S, Mavuduru R. Evaluation of short term efficacy of different alfa adrenergic blockers on LUTS in patients with symptomatic BPH. Journal of Endourology 2013; Vol. 27:A75‐76.
Manohar 2014 {published data only}
    1. Manohar CS, Kamath AJ. Prospective randomize study of clinical out come of management of luts in BPH using silodosin/tamsulosin/alfuzosin. Indian Journal of Urology 2014; Vol. 30:S94‐5.
Miyamae 2011 {published data only}
    1. Miyamae K, Kitani K, Miyamoto K, Nakakuma K, Yamamoto T, Maehara A, et al. Investigation of the early effects of 1‐blockers in a comparative study focusing on patient evaluation. International Urogynecology Journal and Pelvic Floor Dysfunction 2011; Vol. 22:S253‐4.
NCT01222650 {unpublished data only}
    1. NCT01222650. A randomized, double‐blind, placebo‐controlled, multicentre study of KSO‐0400 in BPH patients with LUTS. clinicaltrials.gov/ct2/show/NCT01222650?term=NCT01222650&rank=1 (date first received 01 September 2017).
Pawar 2015 {published data only}
    1. Pawar DS, Kumar A, Singh R, Singh SK. Comparative evaluation of silodosin and tamsulosin in treatment of patients with lower urinary tract symptoms with benign prostatic hyperplasia. Indian Journal of Urology 2015; Vol. 31:S137.

References to ongoing studies

CTRI/2013/10/004112 {unpublished data only}
    1. CTRI/2013/10/004112. A study to find out the medication which offers maximum health benefits with minimum spending by the patient among the three commonly used medications in the treatment of benign prostatic hyperplasia, a disease in aging men which results in bothersome urinary problems. apps.who.int/trialsearch/Trial2.aspx?TrialID=CTRI/2013/10/004112 (date first received 01 September 2017).
JPRN‐UMIN000003609 {unpublished data only}
    1. JPRN‐UMIN000003609. The effects of selective alpha‐1‐adrenergic receptor antagonists in patients with lower urinary tract symptoms caused by benign prostatic hyperplasia who failed to obtain sufficient efficacy by previous alpha‐1‐blockades. A comparison of naftopidil or silodosin. apps.who.int/trialsearch/Trial2.aspx?TrialID=JPRN‐UMIN000003609 (date first received 01 September 2017).

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