Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study

Int Urogynecol J Pelvic Floor Dysfunct. 1998;9(3):145-50. doi: 10.1007/BF02001083.

Abstract

Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adrenergic alpha-Agonists / administration & dosage*
  • Adrenergic alpha-Agonists / adverse effects
  • Adult
  • Aged
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Midodrine / administration & dosage*
  • Midodrine / adverse effects
  • Treatment Outcome
  • Urethra / drug effects
  • Urinary Incontinence, Stress / drug therapy*
  • Urinary Incontinence, Stress / etiology
  • Urodynamics / drug effects

Substances

  • Adrenergic alpha-Agonists
  • Midodrine