Refractory Urge Incontinence and Botox Injections

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Urinary Incontinence, Detrusor Overactivity, Urinary Urgency, Urge Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT00373789

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

87

Starts

2006-06-01

Expected to finish

2007-12-01

Last updated by the study team

2011-01-11

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• USCD Medical Center — La Jolla, California, United States
• Kaiser Permanente — San Diego, California, United States
• Loyola University — Maywood, Illinois, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Southwestern — Dallas, Texas, United States
• Univeristy of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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