NCT00578097

Efficacy and Safety Study of Botulinum Toxin Type-A (Dysport®) in Continent Female Subjects Suffering From Idiopathic Overactive Bladder

A Phase II, International, Multi-centre, Prospective, Randomised, Parallel-group, Double-blind, Dose-ranging, Placebo-controlled, 12-week, Princeps Study to Assess the Efficacy and Safety of a One Injection Cycle With Either Botulinum Toxin Type-A (Dysport® 125, 250 or 500 Units) or Placebo Followed by an Optional 6-month Extension Phase in the Symptomatic Treatment of Micturition Urgency and Frequency in Continent Female Subjects Suffering From Idiopathic Overactive Bladder.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Ipsen · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the optimal dose of botulinum toxin type A injected in the detrusor muscle to improve urinary symptoms, urodynamic parameters and quality of life of continent women suffering from idiopathic overactive bladder.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Single injection cycle, intradetrusor injection at baseline visit 2 of either 125 units (arm A), 250 units (arm B) or 500 units (arm C) in total.
DRUG	Placebo	Single injection cycle, intradetrusor injection at baseline (visit 2).

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2007-12-20
• Last updated: 2019-11-22

Locations

34 sites across 8 countries: Belgium, Czechia, France, Germany, Italy, Netherlands, Spain, United Kingdom