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Randomized Trial for Botox Urinary Incontinence

This study has been completed.
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Michael Flynn, University of Rochester Identifier:
First received: September 12, 2005
Last updated: September 27, 2011
Last verified: September 2011
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
Other: Bladder diary
Other: Questionnaires
Procedure: Urodynamics
Other: Pad weight

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Botox for Severe Urge Incontinence

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Episodes/Day [ Time Frame: 9 months ]
    number of incontinence episodes/day

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)
Arms Assigned Interventions
Experimental: 200 units Botox
200 units Botulinum-A toxin
Other: Bladder diary
3-day bladder diary
Other: Questionnaires
Incontinence Quality of Life questionnaires
Procedure: Urodynamics
Other: Pad weight
Pad weight
Experimental: 300 units Botox
300 units Botulinum-A toxin
Other: Bladder diary
3-day bladder diary
Other: Questionnaires
Incontinence Quality of Life questionnaires
Procedure: Urodynamics
Other: Pad weight
Pad weight
Placebo Comparator: Placebo
Other: Bladder diary
3-day bladder diary
Other: Questionnaires
Incontinence Quality of Life questionnaires
Procedure: Urodynamics
Other: Pad weight
Pad weight

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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00178191

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Principal Investigator: Michael K Flynn, MD University of Rochester
  More Information

Responsible Party: Michael Flynn, MD, University of Rochester Identifier: NCT00178191     History of Changes
Other Study ID Numbers: 10466
1R21AG025490-01 ( US NIH Grant/Contract Award Number )
Study First Received: September 12, 2005
Results First Received: June 12, 2009
Last Updated: September 27, 2011

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 22, 2017