Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.

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Detailed Description

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Conditions

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Overactive Bladder

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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1

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

Group Type EXPERIMENTAL

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

Intervention Type BIOLOGICAL

botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

2

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

Group Type EXPERIMENTAL

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

Intervention Type BIOLOGICAL

botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

3

botulinum toxin Type A (200U)

Group Type EXPERIMENTAL

botulinum toxin Type A (200U)

Intervention Type BIOLOGICAL

botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

4

placebo; botulinum toxin Type A (200U)

Group Type OTHER

Normal saline (Placebo); botulinum toxin Type A (200U)

Intervention Type BIOLOGICAL

Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor

Interventions

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Normal saline (Placebo); botulinum toxin Type A (200U)

Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor

Intervention Type BIOLOGICAL

botulinum toxin Type A (50U); botulinum toxin Type A (200U)

botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Intervention Type BIOLOGICAL

botulinum toxin Type A (100U); botulinum toxin Type A (200U)

botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Intervention Type BIOLOGICAL

botulinum toxin Type A (200U)

botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX® BOTOX® BOTOX® BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No