drugset / Trial / NCT00578097

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

NCT00578097 ↗

Phase 2 Terminated 81 enrolled Ipsen
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-02
Primary completion
2009-06
Completion
2009-12

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated early due to poor recruitment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 125 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 250 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 500 iu Other

Indications