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BMC Urology
Published in: BMC Urology 1/2018

Open Access 01-12-2018 | Research article

Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study

Authors: Ferdinando Fusco, Massimiliano Creta, Nicola Longo, Francesco Persico, Marco Franco, Vincenzo Mirone

Published in: BMC Urology | Issue 1/2018

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Abstract

Background

To preliminary investigate the effects of silodosin 8 mg once daily on obstruction urodynamic parameters and subjective symptoms in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement.

Methods

We performed a single-center, open-label, single-arm, post-marketing interventional clinical trial. Inclusion criteria were: Caucasian subjects aged ≥50 years waiting to undergo surgery for lower urinary tract symptoms suggestive of benign prostatic enlargement, international prostate symptom total score ≥ 13, international prostate symptom-quality of life score ≥ 3, prostate volume ≥ 30 ml, maximum urine flow rate ≤ 15 mL/s, bladder outlet obstruction index > 40. Eligible subjects received one capsule of silodosin 8 mg once daily for 8 weeks. Invasive urodynamic evaluations were performed at baseline and at 8-weeks follow-up. International prostate symptom questionnaire was administered at baseline, after 4-weeks and 8-weeks of treatment.

Results

Overall, 34 subjects were included. Mean bladder outlet obstruction index significantly decreased from 70.6 to 39.2 and bladder outlet obstruction index class improved in 16 patients (53.3%). Statistically significant improvements of mean total international prostate symptom score, mean storage sub-score, mean voiding sub-score and mean quality of life sub-score were evident after 4-weeks of treatment with further improvements after 8-weeks. At the end of the treatment, all patients declared that their condition improved enough to spare or delay surgery.

Conclusions

Silodosin 8 mg once daily significantly improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement waiting for surgery.

Trial registration

EudraCT n. 2015-002277-38 Date of registration: 15th December 2017.
Literature
1.
Osman NI, Chapple CR, Cruz F, Desgrandchamps F, Llorente C, Montorsi F. Silodosin: a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia. Expert Opin Pharmacother. 2012 Oct;13(14):2085–96.CrossRefPubMed
2.
Lepor H, Shapiro E. Characterization of alpha1 adrenergic receptors in human benign prostatic hyperplasia. J Urol. 1984;132(6):1226–9.CrossRefPubMed
3.
Lepor H, Tang R, Meretyk S, Shapiro E. Alpha 1 adrenoceptor subtypes in the human prostate. J Urol. 1993;149(3):640–2.CrossRefPubMed
4.
Kobayashi S, Tang R, Shapiro E, Lepor H. Characterization and localization of prostatic alpha 1 adrenoceptors using radioligand receptor binding on slide-mounted tissue section. J Urol. 1993;150(6):2002–6.CrossRefPubMed
5.
Walden PD, Gerardi C, Lepor H. Localization and expression of the alpha1A-1, alpha1B and alpha1D-adrenoceptors in hyperplastic and non-hyperplastic human prostate. J Urol. 1999;161(2):635–40.CrossRefPubMed
6.
Forray C, Bard JA, Wetzel JM, et al. The alpha 1-adrenergic receptor that mediates smooth muscle contraction in human prostate has the pharmacological properties of the cloned human alpha 1c subtype. Mol Pharmacol. 1994;45(4):703–8.PubMed
7.
Imperatore V, Fusco F, Creta M, et al. Medical expulsive therapy for distal ureteric stones: tamsulosin versus silodosin. Arch Ital Urol Androl. 2014 Jun 30;86(2):103–7.CrossRefPubMed
8.
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 Int. 2006 Nov;98(5):1019–24.CrossRefPubMed
9.
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Silodosin in the treatment of the signs and symptoms of benign prostatic hyperplasia: a 9-month, open-label extension study. Urology. 2009 Dec;74(6):1318–22.CrossRefPubMed
10.
Chapple CR, Montorsi F, Tammela TL, 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. Eur Urol. 2011 Mar;59(3):342–52.CrossRefPubMed
11.
Osman NI, Chapple CR, Tammela TL, Eisenhardt A, Oelke M. Open-label, 9-month extension study investigating the uro-selective alpha-blocker silodosin in men with LUTS associated with BPH. World J Urol. 2015 May;33(5):697–706.CrossRefPubMed
12.
Fusco F, Creta M, Imperatore V, et al. Benign prostatic obstruction relief in patients with lower urinary tract symptoms suggestive of benign prostatic enlargement undergoing endoscopic surgical procedures or therapy with alpha-blockers: a review of urodynamic studies. Adv Ther. 2017 Apr;34(4):773–83.CrossRefPubMed
13.
Fusco F, Palmieri A, Ficarra V, et al. α1-blockers improve benign prostatic obstruction in men with lower urinary tract symptoms: a systematic review and meta-analysis of urodynamic studies. Eur Urol. 2016 Jun;69(6):1091–101.CrossRefPubMed
14.
Creta M, Bottone F, Sannino S, et al. Effects of alpha1-blockers on urodynamic parameters of bladder outlet obstruction in patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: a review. Minerva Urol Nefrol. 2016;68(2):209–21.
15.
Matsukawa Y, Gotoh M, Komatsu T, Funahashi Y, Sassa N, Hattori R. Efficacy of silodosin for relieving benign prostatic obstruction: prospective pressure flow study. J Urol. 2009;182:2831–5.CrossRefPubMed
16.
Yamanishi T, Mizuno T, Tatsumiya K, Watanabe M, Kamai T, Yoshida K. Urodynamic effects of silodosin, a new alpha 1A-adrenoceptor selective antagonist, for the treatment of benign prostatic hyperplasia. Neurourol Urodyn. 2010;29:558–62.PubMed
17.
Matsukawa Y, Takai S, Funahashi Y, Kato M, Yamamoto T, Gotoh M. Long-term efficacy of a combination therapy with an anticholinergic agent and an α1-blocker for patients with benign prostatic enlargement complaining both voiding and overactive bladder symptoms: a randomized, prospective, comparative trial using a urodynamic study. Neurourol Urodyn. 2017 Mar;36(3):748–54.CrossRefPubMed
18.
Kurose K, Sugiyama E, Saito Y. Population differences in major functional polymorphisms of pharmacokinetics/pharmacodynamics-related genes in Eastern Asians and Europeans: implications in the clinical trials for novel drug development. Drug Metab Pharmacokinet. 2012;27(1):9–54. Epub 2011 Nov 29.CrossRefPubMed
19.
Rossi M, Roumeguère T. Silodosin in the treatment of benign prostatic hyperplasia. Drug Des Devel Ther. 2010 Oct 27;4:291–7.PubMedPubMedCentral
20.
Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the Standardisation Subcommittee of the International Continence Society. Urology. 2003;61:37.CrossRefPubMed
21.
Nitti VW. Pressure flow urodynamic studies: the gold standard for diagnosing bladder outlet obstruction. Rev Urol. 2005;7(Suppl 6):S14–21.PubMedPubMedCentral
22.
Gratzke C, Bachmann A, Descazeaud A, et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol. 2015;67:1099–109.CrossRefPubMed
Metadata
Title
Silodosin 8 mg improves benign prostatic obstruction in Caucasian patients with lower urinary tract symptoms suggestive of benign prostatic enlargement: results from an explorative clinical study
Authors
Ferdinando Fusco
Massimiliano Creta
Nicola Longo
Francesco Persico
Marco Franco
Vincenzo Mirone
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2018
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/s12894-018-0326-7

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