title: Comparison of the efficacy and safety of tolterodine 2 mg and 4 mg combined with an α-blocker in men with lower urinary tract symptoms (LUTS) and overactive bladder: a randomized controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of low-dose (2 mg) tolterodine extended release (ER) with an α-blocker compared with standard-dose (4 mg) tolterodine ER with an α-blocker for the treatment of men with residual storage symptoms after α-blocker monotherapy.
  
  
  METHODS
  The study was a 12-week, single-blind, randomized, parallel-group, non-inferiority trial that included men with residual storage symptoms despite receiving at least 4 weeks of α-blocker treatment. Inclusion criteria were total International Prostate Symptom Score (IPSS) ≥12, IPSS quality-of-life item score ≥3, and ≥8 micturitions and ≥2 urgency episodes per 24 h. The primary outcome was change in the total IPSS score from baseline. Bladder diary variables, patient-reported outcomes and safety were also assessed.
  
  
  RESULTS
  Patients were randomly assigned to addition of either 2 mg tolterodine ER (n = 47) or 4 mg tolterodine ER (n = 48) to α-blocker therapy for 12 weeks. Patients in both treatment groups had a significant improvement in total IPSS score (-5.5 and -6.3, respectively), micturition per 24 h (-1.3 and -1.7, respectively) and nocturia per night (-0.4 and -0.4, respectively). Changes in IPSS, bladder diary variables, and patient-reported outcomes were not significantly different between the treatment groups. All interventions were well tolerated by patients.
  
  
  CONCLUSIONS
  These results suggest that 12 weeks of low-dose tolterodine ER add-on therapy is similar to standard-dose tolterodine ER add-on therapy in terms of efficacy and safety for patients experiencing residual storage symptoms after receiving α-blocker monotherapy.
authors: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Tae Heon
authors: TH
authors: Kim
authors: Department of Urology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
authors: Wonho
authors: W
authors: Jung
authors: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Yoon Seok
authors: YS
authors: Suh
authors: Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea.
authors: Soonhyun
authors: S
authors: Yook
authors: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Hyun Hwan
authors: HH
authors: Sung
authors: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.|Department of Medical Device Management and Research, SAIHST, Sungkyunkwan University, Seoul, Korea.
authors: Kyu-Sung
authors: KS
authors: Lee
mesh_terms: D000368:Aged; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D011788:Quality of Life; D016037:Single-Blind Method; D000068737:Tolterodine Tartrate / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D000068737:Tolterodine Tartrate
keywords: anticholinergics; benign prostatic hyperplasia; overactive bladder