Refractory Urge Incontinence and Botox Injections

Refractory Urge Incontinence and Botox Injections

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.

Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.

Inclusion Criteria:

• Adult women
• Detrusor overactivity incontinence confirmed by urodynamic testing
• Symptoms refractory to standard first- and second-line treatments
• 6 or more urge incontinence episodes on 3-day bladder diary
• Normal neurological examination

Exclusion Criteria:

• Urinary retention
• Allergy to Botox (Botulinum Toxin A)
• Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
• Pregnancy or planning pregnancy within next year
• Neurologic disease with impaired neurotransmission