Randomized Trial for Botox Urinary Incontinence

A Randomized Trial of Botox for Severe Urge Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Bladder diary; 3-day bladder diary; Other: Questionnaires; Incontinence Quality of Life questionnaires; Procedure: Urodynamics; Urodynamics; Other: Pad weight; Pad weight
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes/Day	number of incontinence episodes/day	9 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Michael K Flynn, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 27, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 10466 (Other Identifier: CTEP); 1R21AG025490-01 (U.S. NIH Grant/Contract)