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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 ≥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 reported greater treatment satisfaction with tadalafil vs placebo, with only borderline difference for men without prior therapy. Conclusion Treatment satisfaction was greater with tadalafil vs placebo, with no significant difference between tamsulosin and placebo.