Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study

J Urol. 2005 Oct;174(4 Pt 1):1334-8. doi: 10.1097/01.ju.0000173630.94559.fd.

Abstract

Purpose: We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder (OAB) and benign prostatic obstruction.

Materials and methods: Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction (Abrams-Griffith score greater than 20) were randomized (1:2) into 2 groups, namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation (4 mg once daily) only and group 2-propiverine hydrochloride (20 mg once daily) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen.

Results: A total of 211 men, including 69 in group 1 and 142 in group 2, were treated and 198 (93.8%) completed the 8 weeks of treatment. Significant improvements were noted in each group after treatment in urinary frequency, maximum flow rate, average micturition volume and International Prostate Symptom Score. Compared with group 1 improvement rates with regard to urinary frequency (23.5% vs 14.3%, p = 0.004), average micturition volume (32.3% vs 19.2%, p = 0.004), and storage (41.3% vs 32.6%, p = 0.029) and urgency (p = 0.019) International Prostate Symptom Score symptoms were more significant in group 2. Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention. Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 (p = 0.002). Overall adverse event rates were higher in group 2 (p = 0.002), although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups.

Conclusions: This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenergic alpha-Antagonists / administration & dosage*
  • Aged
  • Benzilates / therapeutic use*
  • Comorbidity
  • Delayed-Action Preparations
  • Doxazosin / administration & dosage*
  • Drug Therapy, Combination
  • Humans
  • Male
  • Middle Aged
  • Muscarinic Antagonists / therapeutic use*
  • Parasympatholytics / therapeutic use*
  • Patient Satisfaction
  • Prospective Studies
  • Prostatic Hyperplasia / drug therapy*
  • Prostatic Hyperplasia / epidemiology
  • Prostatic Hyperplasia / physiopathology
  • Urinary Incontinence / drug therapy*
  • Urinary Incontinence / epidemiology
  • Urinary Incontinence / physiopathology

Substances

  • Adrenergic alpha-Antagonists
  • Benzilates
  • Delayed-Action Preparations
  • Muscarinic Antagonists
  • Parasympatholytics
  • propiverine
  • Doxazosin