Treatment Satisfaction with Tadalafil or Tamsulosin versus Placebo in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: Results from a Randomized, Placebo-controlled Study
Oelke M1, Giuliano F, Baygani SK, Melby T, Sontag A. BJU Int. 2014 Mar 10. doi: 10.1111/bju.12733. [Epub ahead of print]

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1Department of Urology, Hannover Medical School, Hannover, Germany.


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

CONCLUSION: ● Treatment satisfaction was greater with tadalafil versus placebo, with no significant difference between tamsulosin and placebo.