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

Allergan

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Biological: botulinum toxin Type A (200U); Other: Normal Saline (Placebo); botulinum toxin Type A (200U); Other: Normal Saline (Placebo); botulinum toxin Type A (300U); Biological: botulinum toxin Type A (300U)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00311376

191622-515

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Enrollment: 416 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 4 patient groups

1

Experimental group

Description:

botulinum toxin Type A (200U)

Treatment:

Biological: botulinum toxin Type A (200U)

2

Experimental group

Description:

botulinum toxin Type A (300U)

Treatment:

Biological: botulinum toxin Type A (300U)

3

Other group

Description:

placebo; botulinum toxin Type A (200U)

Treatment:

Other: Normal Saline (Placebo); botulinum toxin Type A (200U)

4

Other group

Description:

placebo; botulinum toxin Type A (300U)

Treatment:

Other: Normal Saline (Placebo); botulinum toxin Type A (300U)