drugset / Trial / NCT00231491

Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.

NCT00231491 ↗

Phase 2 Completed 160 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupDouble-blindTreatment

Summary

Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.

Timeline

Start
2005-11
Primary completion
2010-04
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 150 iu Other

Indications