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Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies

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Abstract

Objectives

Nocturia is prevalent and bothersome in men with lower urinary tract symptoms suggestive of BPH (LUTS/BPH). α-Adrenoceptor antagonists without subtype selectivity have inconsistently shown significant effects on nocturia in these patients. We explored the effects of the α1A-adrenoceptor subtype-selective antagonist silodosin on nocturia by analyzing three placebo-controlled registration studies.

Methods

Responses to question 7 of the IPSS questionnaire were analyzed for the entire study population and patients with ≥2 voids/night at baseline. Improvement/worsening rates for nocturia were calculated for once-daily silodosin 8 mg and placebo. Silodosin effects on the mean number of nocturnal voids were compared with placebo, and the number of patients in whom nocturia was reduced to <2 times was calculated.

Results

In total, 1,479 men were treated with silodosin or placebo; 1,266 men (85 %) had ≥2 voids/night at baseline. Compared to placebo, more men treated with silodosin reported about nocturia improvement (53.4 vs. 42.8 %, p < 0.0001) and fewer patients about worsening (9.0 vs. 14.3 %, p < 0.0001). Silodosin significantly reduced nocturia within each study and pooled cohort compared to placebo (p < 0.001). In men with ≥2 nocturnal voids at baseline, 61 and 49 % of patients with silodosin and placebo had reductions of ≥1 voids/night, respectively (p = 0.0003), and significantly more patients with silodosin had <2 nocturia episodes at study end compared to placebo (29.3 vs. 19.0 %; p = 0.0002).

Conclusions

Although a weak impact on nocturia is already known from α-adrenoceptor antagonists without subtype selectivity, the individual placebo-controlled studies and the pooled data analysis showed that the α1A-adrenoceptor subtype-selective antagonist silodosin consistently and significantly improves nocturia in men with LUTS/BPH.

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Acknowledgments

The authors would like to thank Dr. Massimo Casi from Recordati S.p.A., Italy, for providing the study data and Mr. Alessandro Antonellini from Recordati S.p.A., Italy, for his statistical support.

Conflict of interest

A.S. is speaker, advisor and/or trial participant of Berlin-Chemie, Ipsen, Janssen-Cilag, Lilly, Recordati and Takeda. T.S. is speaker, advisor and/or trial participant of Allergan, Astellas, Bayer, Berlin-Chemie, Pfizer, Recordati and Takeda. F.C. is speaker, advisor and/or trial participant of Allergan, Astellas, Ipsen, Janssen-Cilag, Pfizer and Recordati. M.O. is speaker, advisor and/or trial participant of Allergan, Apogepha, Astellas, Ferring, GlaxoSmithKline, Lilly, Pfizer, Recordati and Sophiris.

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Authors and Affiliations

  1. PUR/R Practice Clinic Urology Rhein-Ruhr, Mülheim, Germany

    Andreas Eisenhardt & Tim Schneider

  2. Department of Urology, Hospital de S. João, University of Porto, Porto, Portugal

    Francisco Cruz

  3. Department of Urology, Hannover Medical School, Carl-Neuberg-Str.1, 30625, Hannover, Germany

    Matthias Oelke

Authors
  1. Andreas Eisenhardt
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  2. Tim Schneider
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  3. Francisco Cruz
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  4. Matthias Oelke
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Correspondence to Matthias Oelke.

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Eisenhardt, A., Schneider, T., Cruz, F. et al. Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies. World J Urol 32, 1119–1125 (2014). https://doi.org/10.1007/s00345-013-1228-7

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  • DOI: https://doi.org/10.1007/s00345-013-1228-7

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