OBJECTIVES: To assess treatment satisfaction with tadalafil or tamsulosin versus placebo in a 12-week, randomized, double-blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH).
PATIENTS AND METHODS: Following a 4-week placebo lead-in period, men aged ≥45 years with IPSS ≥13 and Qmax ≥4 to ≤ 15 mL/s received placebo (N=172), tadalafil 5-mg (N=171), or tamsulosin 0.4-mg (N=168) once daily for 12 weeks. Treatment Satisfaction Scale-BPH (TSS-BPH) responses were assessed based on median treatment differences using the van Elteren test.
RESULTS: Overall treatment satisfaction was greater for tadalafil versus placebo (p=0.005), based on greater satisfaction with efficacy (p=0.003); neither overall treatment satisfaction nor satisfaction with efficacy was greater for tamsulosin versus placebo (p≥0.409). For individual questions, 66.5% of men rated tadalafil treatment as effective/very effective (Q1; versus placebo, p=0.011), 72.6% would definitely/probably recommend their treatment (Q3; p=0.043), 71.8% were generally very satisfied/satisfied with their medication (Q8; p< 0.003), and 65.0% would definitely/probably continue therapy (Q10; p=0.035). With tamsulosin, differences versus placebo were not statistically significant. Subgroup analyses of overall TSS-BPH by baseline age (≤ 65/>65), history of erectile dysfunction (yes/no), LUTS/BPH severity (IPSS < /≥20), total testosterone level (< 300/≥300 ng/dL), and age-specific predicted prostate volume (< 40/≥40 mL) showed no statistically significant treatment-subgroup interactions. Men with recent prior α-blocker therapy demonstrated greater treatment satisfaction with tadalafil versus placebo, with only borderline difference for men without prior therapy.
CONCLUSION: Treatment satisfaction was greater with tadalafil versus placebo, with no significant difference between tamsulosin and placebo.
Written by:
Oelke M, Giuliano F, Baygani SK, Melby T, Sontag A. Are you the author?
Department of Urology, Hannover Medical School, Hannover, Germany.
Reference: BJU Int. 2014 Mar 10. Epub ahead of print.
doi: 10.1111/bju.12733
PubMed Abstract
PMID: 24612148
