Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-01

Study Completion Date

2014-08-05

Brief Summary

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The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.

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Detailed Description

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Conditions

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Overactive Bladder Urinary Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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botulinum toxin Type A 100U

Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

botulinum toxin Type A 150U

Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Interventions

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botulinum toxin Type A

Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Intervention Type BIOLOGICAL

Other Intervention Names

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BOTOX®

Eligibility Criteria

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Inclusion Criteria

* Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)

Exclusion Criteria

* Females who are pregnant, nursing or planning a pregnancy
* Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No