title: 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.
abstract: OBJECTIVE
  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).
  
  
  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 Elteren 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.
  
  
  CONCLUSIONS
  Treatment satisfaction was greater with tadalafil vs placebo, with no significant difference between tamsulosin and placebo.
authors.affiliation: Department of Urology, Hannover Medical School, Hannover, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
authors.forename: François
authors.initials: F
authors.lastname: Giuliano
authors.forename: Simin K
authors.initials: SK
authors.lastname: Baygani
authors.forename: Thomas
authors.initials: T
authors.lastname: Melby
authors.forename: Angelina
authors.initials: A
authors.lastname: Sontag
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011470:Prostatic Hyperplasia / Q000150:complications*; D013449:Sulfonamides / Q000627:therapeutic use*; D000068581:Tadalafil; D000077409:Tamsulosin; D016896:Treatment Outcome; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D002243:Carbolines; D013449:Sulfonamides; D064804:Urological Agents; D000068581:Tadalafil; D000077409:Tamsulosin
keywords: patient satisfaction; phosphodiesterase type 5 inhibitors; randomised controlled trial; tadalafil; tamsulosin; treatment satisfaction