Status:
COMPLETED
Randomized Trial for Botox Urinary Incontinence
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
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.
Detailed Description
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or ...
Eligibility Criteria
Inclusion
- Subjects must have ALL of the following:
- Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit
- Symptoms of urge incontinence associated with leakage on bladder diary
- 24-hour pad weight \>100 cc's (volume requiring multiple daily diaper changes)
- Absence of a bladder infection or other condition that could explain urinary leakage
- Absence of stress incontinence or a cough leak point pressure \> 100 cm H2O on cystometry (this correlates with mild stress incontinence)
- Failed anticholinergic therapy
- Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox)
- The ability and willingness to return for surveillance evaluations
- A negative urine pregnancy test if at risk for pregnancy
- Competent to give signed consent and complete all of the study measures
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00178191
Start Date
June 1 2005
End Date
July 1 2008
Last Update
October 3 2011
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642