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Treatment satisfaction with tadalafil or tamsulosin vs placebo in men with lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ): results from a randomised, placebo‐controlled study
Author(s) -
Oelke Matthias,
Giuliano François,
Baygani Simin K.,
Melby Thomas,
Sontag Angelina
Publication year - 2014
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12733
Subject(s) - tadalafil , tamsulosin , lower urinary tract symptoms , placebo , medicine , international prostate symptom score , urology , benign prostatic hyperplasia (bph) , erectile dysfunction , prostate , hyperplasia , alternative medicine , pathology , cancer
Objectives To assess treatment satisfaction with tadalafil or tamsulosin vs placebo in a 12‐week, randomised, double‐blind study of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS / BPH ). Patients and Methods After a 4‐week placebo lead‐in period, men aged ≥45 years with an International Prostate Symptom Score ( IPSS ) of ≥13 and a maximum urinary flow rate of ≥4 to ≤15 mL/s received placebo (172 men), tadalafil 5 mg (171), or tamsulosin 0.4 mg (168) once daily for 12 weeks. Treatment Satisfaction Scale‐ BPH ( TSS‐BPH ) responses were assessed based on median treatment differences using the van E lteren test. Results Overall treatment satisfaction was greater for tadalafil vs 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 vs placebo ( P ≥ 0.409). For individual questions, 66.5% of men rated tadalafil treatment as ‘effective/very effective’ (Question 1, Q1) vs 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 vs placebo were not statistically significant. Subgroup analyses of overall TSS‐BPH by baseline age (≤65/>65 years), history of erectile dysfunction (yes/no), LUTS / BPH severity ( IPSS