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Randomized Trial for Botox Urinary Incontinence

NCT ID: NCT00178191

Last Updated: 2011-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-07-31

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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200 units Botox

200 units Botulinum-A toxin

Group Type EXPERIMENTAL

Bladder diary

Intervention Type OTHER

3-day bladder diary

Questionnaires

Intervention Type OTHER

Incontinence Quality of Life questionnaires

Urodynamics

Intervention Type PROCEDURE

Urodynamics

Pad weight

Intervention Type OTHER

Pad weight

300 units Botox

300 units Botulinum-A toxin

Group Type EXPERIMENTAL

Bladder diary

Intervention Type OTHER

3-day bladder diary

Questionnaires

Intervention Type OTHER

Incontinence Quality of Life questionnaires

Urodynamics

Intervention Type PROCEDURE

Urodynamics

Pad weight

Intervention Type OTHER

Pad weight

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Bladder diary

Intervention Type OTHER

3-day bladder diary

Questionnaires

Intervention Type OTHER

Incontinence Quality of Life questionnaires

Urodynamics

Intervention Type PROCEDURE

Urodynamics

Pad weight

Intervention Type OTHER

Pad weight

Interventions

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Bladder diary

3-day bladder diary

Intervention Type OTHER

Questionnaires

Incontinence Quality of Life questionnaires

Intervention Type OTHER

Urodynamics

Urodynamics

Intervention Type PROCEDURE

Pad weight

Pad weight

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Michael Flynn

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael K Flynn, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1R21AG025490-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10466

Identifier Type: -

Identifier Source: org_study_id