Refractory Urge Incontinence and Botox Injections

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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