Randomized Trial for Botox Urinary Incontinence

Completed · Not applicable · Has a placebo group

Conditions studied: Urinary Incontinence

In brief

The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Key facts

Study ID

NCT00178191

Run by

University of Rochester

People needed

28

Starts

2005-06-01

Expected to finish

2008-07-01

Last updated by the study team

2011-10-03

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may not qualify if…

• Children (< 21 years old), pregnant women and prisoners
• History of carcinoma of the bladder
• Absence of a measurable detrusor contraction on a pressure flow micturition study
• A foreign body in the bladder or other correctable etiology for the UUI
• Prior documented resistance to Botox
• Gross fecal incontinence (due to confounding effects on pad weights and counts)
• Known allergy to lidocaine or related compounds (used for local analgesia)
• Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
• Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
• Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.