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 - 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.

Written by:
Eisenhardt A, Schneider T, Cruz F, Oelke M.   Are you the author?
PUR/R Practice Clinic Urology Rhein-Ruhr, Mülheim, Germany.

Reference: World J Urol. 2014 Jan 18. Epub ahead of print.
doi: 10.1007/s00345-013-1228-7


PubMed Abstract
PMID: 24442560

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