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

Allergan

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence; Overactive Bladder

Treatments: Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00915525

191622-096

Details and patient eligibility

About

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.

Enrollment: 829 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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829 participants in 2 patient groups

botulinum toxin Type A 100U

Experimental group

Description:

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

Treatment:

Biological: botulinum toxin Type A

botulinum toxin Type A 150U

Experimental group

Description:

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

Treatment:

Biological: botulinum toxin Type A