Refractory Urge Incontinence and Botox Injections

Phase 3 Terminated 87 enrolled Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.

Timeline

Start: 2006-06
Primary completion: 2007-12
Completion: 2007-12

Outcome

Met primary endpoint

Stopped: “higher than anticipated rate of increased post-void residual in subjects who received botulinum toxin A injection”

paper The median duration of their responses was 373 days, significantly longer than the 62 days or less for placebo (p <0.0001). PMID 18499184 ↗

Publications

Results Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Other