Botulin-A Toxin Instillations and Overactive Bladder

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

Outcome

Mixed primary results

paper median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month (P=.004) PMID 19648387 ↗

paper increased to 4 at 3 months (P=.81) PMID 19648387 ↗

Publications

• Results Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.

Drugs

Evaluation	Drug	Modality	Dose	Route
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