Randomized Trial for Botox Urinary Incontinence

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Michael Flynn, University of Rochester
ClinicalTrials.gov Identifier:
NCT00178191
First received: September 12, 2005
Last updated: September 27, 2011
Last verified: September 2011
  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
Other: Bladder diary
Other: Questionnaires
Procedure: Urodynamics
Other: Pad weight

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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
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
Urodynamics
Other: Pad weight
Pad weight
Placebo Comparator: Placebo
Placebo
Other: Bladder diary
3-day bladder diary
Other: Questionnaires
Incontinence Quality of Life questionnaires
Procedure: Urodynamics
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Michael Flynn, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT00178191     History of Changes
Other Study ID Numbers: 10466, 1R21AG025490-01
Study First Received: September 12, 2005
Results First Received: June 12, 2009
Last Updated: September 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014