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Randomized Trial for Botox Urinary Incontinence

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bladder diary
Questionnaires
Urodynamics
Pad weight
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

200 units Botox

300 units Botox

Placebo

Arm Description

200 units Botulinum-A toxin

300 units Botulinum-A toxin

Placebo

Outcomes

Primary Outcome Measures

Episodes/Day
number of incontinence episodes/day

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
September 27, 2011
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00178191
Brief Title
Randomized Trial for Botox Urinary Incontinence
Official Title
A Randomized Trial of Botox for Severe Urge Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
200 units Botox
Arm Type
Experimental
Arm Description
200 units Botulinum-A toxin
Arm Title
300 units Botox
Arm Type
Experimental
Arm Description
300 units Botulinum-A toxin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Other
Intervention Name(s)
Bladder diary
Intervention Description
3-day bladder diary
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Incontinence Quality of Life questionnaires
Intervention Type
Procedure
Intervention Name(s)
Urodynamics
Intervention Description
Urodynamics
Intervention Type
Other
Intervention Name(s)
Pad weight
Intervention Description
Pad weight
Primary Outcome Measure Information:
Title
Episodes/Day
Description
number of incontinence episodes/day
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Flynn, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Randomized Trial for Botox Urinary Incontinence

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