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A Research Study for Patients With Overactive Bladder

NCT ID: NCT00168454

Last Updated: 2013-11-06

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

PHASE2

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Detailed Description

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Conditions

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Overactive Bladder Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo (normal saline) injected into detrusor on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (normal saline) injected into detrusor on Day 1

BOTOX 50 U

botulinum toxin Type A 50 U injected into detrusor on Day 1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

BOTOX 100 U

botulinum toxin Type A 100 U injected into detrusor on Day 1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

BOTOX 150 U

botulinum toxin Type A 150 U injected into detrusor on Day 1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

BOTOX 200 U

botulinum toxin Type A 200 U injected into detrusor on Day 1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

BOTOX 300 U

botulinum toxin Type A 300 U injected into detrusor on Day 1

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

botulinum toxin Type A injected into detrusor on Day 1

Interventions

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botulinum toxin Type A

botulinum toxin Type A injected into detrusor on Day 1

Intervention Type BIOLOGICAL

Placebo

Placebo (normal saline) injected into detrusor on Day 1

Intervention Type DRUG

Other Intervention Names

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BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Must be between 18-85 years old
* Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago
* Must weigh at least 50 kg (110 lbs)
* Must be willing and able to record information regarding bladder function into a diary (provided)
* Must be willing and able to complete the entire course of the study

Exclusion Criteria

* Cannot currently be catheterizing as a way to control incontinence
* Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Pittsburgh, Pennsylvania, United States

Site Status

Ghent, , Belgium

Site Status

Victoria, British Columbia, Canada

Site Status

Berlin, , Germany

Site Status

Warsaw, , Poland

Site Status

Sheffield, , United Kingdom

Site Status

Countries

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United States Belgium Canada Germany Poland United Kingdom

References

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Fowler CJ, Auerbach S, Ginsberg D, Hale D, Radziszewski P, Rechberger T, Patel VD, Zhou J, Thompson C, Kowalski JW. OnabotulinumtoxinA improves health-related quality of life in patients with urinary incontinence due to idiopathic overactive bladder: a 36-week, double-blind, placebo-controlled, randomized, dose-ranging trial. Eur Urol. 2012 Jul;62(1):148-57. doi: 10.1016/j.eururo.2012.03.005. Epub 2012 Mar 14.

Reference Type DERIVED
PMID: 22464310 (View on PubMed)

Other Identifiers

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191622-077

Identifier Type: -

Identifier Source: org_study_id