title: Results of a randomized, double-blind, active-controlled clinical trial with propiverine extended release 30 mg in patients with overactive bladder.
abstract: OBJECTIVE
  To compare the efficacy and safety of the 30 mg extended release (ER) formulation of propiverine hydrochloride with the 4 mg ER formulation of tolterodine tartrate in patients with overactive bladder (OAB) in a non-inferiority trial.
  
  
  METHODS
  Eligible patients, aged 18-75 years and with symptoms of OAB, were enrolled in this multicentre, randomized, double-blind, parallel-group, active-controlled study. After a 2-week screening period, patients were randomized at a 1:1 ratio to receive either propiverine ER 30 mg or tolterodine ER 4 mg daily during the 8-week treatment period. Efficacy was assessed using a 3-day voiding diary and patient's self-reported assessment of treatment effect. Safety assessment included recording of adverse events, laboratory test results, measurement of post-void residual urine and electrocardiograms.
  
  
  RESULTS
  A total of 324 patients (244 female and 80 male) were included in the study. Both active treatments improved the variables included in the voiding diary and in the patient's self-reported assessment. The change from baseline in the number of voidings per 24 h was significantly greater in the propiverine ER 30 mg group compared with the tolterodine ER 4 mg group after 8 weeks of treatment (full analysis set [FAS] -4.6 ± 4.1 vs -3.8 ± 5.1; P = 0.005). Significant improvements were also observed for the change of urgency incontinence episodes after 2 weeks (P = 0.026) and 8 weeks (P = 0.028) of treatment when comparing propiverine ER 30 mg with tolterodine ER 4 mg. Both treatments were well tolerated, with a similar frequency of adverse drug reactions in both the propiverine ER 30 mg and tolterodine ER 4 mg groups (FAS 40.7 vs 39.5%; P = 0.8). More patients treated with tolterodine ER 4 mg discontinued the treatment because of adverse drug reactions compared with propiverine ER 30 mg (7.4 vs 3.1%).
  
  
  CONCLUSIONS
  Propiverine ER 30 mg was confirmed to be an effective and well-tolerated treatment option for patients with OAB symptoms. This first head-to-head study showed non-inferiority of propiverine ER 30 mg compared with tolterodine ER 4 mg.
authors.affiliation: Renji Hospital Affiliated to Shanghai JiaoTong University School of Medicine, Shanghai, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Leng
authors.affiliation: Beijing Boai Hospital, Beijing, China.
authors.forename: Limin
authors.initials: L
authors.lastname: Liao
authors.affiliation: Beijing Hospital of the Ministry of Health, Beijing, China.
authors.forename: Ben
authors.initials: B
authors.lastname: Wan
authors.affiliation: Second Affiliated Hospital Zhejiang University College of Medicine, Zhejiang, China.
authors.forename: Chuanjun
authors.initials: C
authors.lastname: Du
authors.affiliation: Second Hospital of Hebei Medical University, Shijiazhuang, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Guangzhou First Municipal People's Hospital, Guangzhou, China.
authors.forename: Keji
authors.initials: K
authors.lastname: Xie
authors.affiliation: Ruijin Hospital Affiliated to Shanghai JiaoTong University School of Medicine, Shanghai, China.
authors.forename: Zhoujun
authors.initials: Z
authors.lastname: Shen
authors.affiliation: Wuxi People's Hospital, Wuxi, China.
authors.forename: Zhuoqun
authors.initials: Z
authors.lastname: Xu
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Shiliang
authors.initials: S
authors.lastname: Wu
authors.affiliation: Huashan Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Zujun
authors.initials: Z
authors.lastname: Fang
authors.affiliation: Peking University Third Hospital, Beijing, China.
authors.forename: Lulin
authors.initials: L
authors.lastname: Ma
authors.affiliation: Basic Medicine Institute of China Academy of Chinese Medical Sciences, Beijing, China.
authors.forename: Shaomei
authors.initials: S
authors.lastname: Han
authors.affiliation: Consultant for APOGEPHA Arzneimittel GmbH, Dresden, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Feustel
authors.affiliation: Beijing Chaoyang Hospital affiliating Capital University of Medical Sciences, Beijing, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yang
authors.affiliation: Medical University Innsbruck, Innsbruck, Austria.
authors.forename: Helmut
authors.initials: H
authors.lastname: Madersbacher
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001561:Benzilates / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D000068737:Tolterodine Tartrate / Q000008:administration & dosage*; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D001561:Benzilates; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; C015586:propiverine; D000068737:Tolterodine Tartrate
keywords: overactive bladder; propiverine hydrochloride ER 30 mg; randomized controlled trial; tolterodine ER 4 mg