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Randomized Trial for Botox Urinary Incontinence
This study has been completed.
Sponsors and Collaborators: University of Rochester
National Institutes of Health (NIH)
Information provided by: University of Rochester
ClinicalTrials.gov Identifier: NCT00178191
  Purpose

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.


Condition Intervention
Urinary Incontinence
Drug: Botulinum A toxin

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Trial of Botox for Severe Urge Incontinence

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 3-day bladder diary [ Time Frame: Within 1 week of visit or mailing ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: June 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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 UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178191

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Michael K Flynn, MD University of Rochester
  More Information

Responsible Party: University of Rochester ( Michael K. Flynn, MD )
Study ID Numbers: 10466
Study First Received: September 12, 2005
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00178191  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Botulinum Toxins
Urologic Diseases
Urination Disorders
Urinary Incontinence
Botulinum Toxin Type A
Urinary Incontinence, Urge

Additional relevant MeSH terms:
Urological Manifestations
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009