drugset / Trial / NCT00583219

Botulin-A Toxin Instillations and Overactive Bladder

NCT00583219

Phase 1/2 Completed 25 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Timeline

Start
2006-03
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 200 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 300 iu Other
Background Dimethyl sulfoxide (DMSO) Unknown 50 ml Other

Indications