title: Efficacy and Safety of Medium-to-long-term Use of Tolterodine Extended Release with or without Tamsulosin in Patients with Benign Prostate Hyperplasia and Larger Prostate Size: A Double-blind, Placebo-controlled, Randomized Clinical Trial.
abstract: BACKGROUND
  The medium-to-long-term use of antimuscarinics alone or in combination with an α-blocker in men with an enlarged prostate is still controversial. This double-blind, placebo-controlled, randomized clinical trial aimed to investigate the efficacy and safety of medium-to-long-term use of tolterodine extended release (ER) with or without tamsulosin in patients with benign prostate hyperplasia (BPH) and larger prostate size.
  
  
  METHODS
  Totally, 152 patients (age ≥50 years) with BPH, International Prostate Symptom Score (IPSS) ≥12, quality-of-life (QoL) score ≥3, and total prostate volume ≥25 ml were enrolled in this study. The patients were randomized into four groups (n = 38 in each) to receive tolterodine ER placebo plus tamsulosin placebo, 0.2 mg tamsulosin plus tolterodine ER placebo, 4 mg tolterodine ER plus tamsulosin placebo, or tolterodine ER plus tamsulosin once daily for 24 weeks. IPSS (total, storage, and voiding subscales), QoL, maximum urinary flow rate (Qmax), and postvoid residual volume (PVR) were collected at baseline, and at weeks 4, 12, and 24.
  
  
  RESULTS
  Compared with placebo, tolterodine ER plus tamsulosin significantly improved total IPSS (-7.15, -12.20, and -14.66 vs. -3.51, -5.78, and -7.23), storage IPSS (-3.56, -5.63, and -6.66 vs. -1.52, -1.21, and -2.43), voiding IPSS (-2.88, -5.10, and -6.48 vs. -1.52, -3.03, and -2.97), QoL (-1.21, -2.40, and -3.21 vs. -0.39, -1.41, and -1.60), Qmax (2.21, 7.97, and 9.72 ml/s vs. 2.15, 2.44, and 2.73 ml/s), and PVR (-17.88, -26.97, and -27.89 ml vs. -12.03, -11.16, and -16.73 ml) at weeks 4, 12, and 24, respectively; the differences were all statistically significant (P < 0.05). Adverse events (AEs) were not increased with treatment progression. Tolterodine ER alone did not improve total IPSS (-4.61, -6.79, and -5.70), voiding IPSS (-0.64, -1.83, and -1.45), QoL (-0.69, -1.21, and -1.41), or Qmax(-0.79, 2.83, and 1.11 ml/s), compared with placebo (all P > 0.05). However, a gradual increase in PVR (10.03, 10.41, and 12.89 ml) and more urinary AEs suggestive of urinary retention (11/38 vs. 4/38) were observed.
  
  
  CONCLUSIONS
  Medium-to-long-term use of tolterodine ER plus tamsulosin should be recommended in patients with BPH and an enlarged prostate volume.
  
  
  BACKGROUND
  www.chictr.org.cn, ChiCTR-TRC-09000596; http://www.chictr.org.cn/showproj.aspx?proj=8939.
authors.affiliation: Department of Urology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.
authors.forename: Jian-Liang
authors.initials: JL
authors.lastname: Cai
authors.affiliation: Peking University Wu Jieping Urology Medical Center, Peking University Shougang Hospital, Beijing 100144, China.
authors.forename: Zhe
authors.initials: Z
authors.lastname: Zhou
authors.affiliation: Peking University Wu Jieping Urology Medical Center, Peking University Shougang Hospital, Beijing 100144, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Department of Urology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.
authors.forename: Yi-Fu
authors.initials: YF
authors.lastname: Yan
authors.affiliation: Department of Urology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.
authors.forename: Shuo
authors.initials: S
authors.lastname: Jing
authors.affiliation: Peking University Wu Jieping Urology Medical Center, Peking University Shougang Hospital, Beijing 100144, China.
authors.forename: Yan-Qun
authors.initials: YQ
authors.lastname: Na
mesh_terms: D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000187:drug effects / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D000077409:Tamsulosin; D000068737:Tolterodine Tartrate / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000317:Adrenergic alpha-Antagonists; D013449:Sulfonamides; D000068737:Tolterodine Tartrate; D000077409:Tamsulosin