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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Overactive Bladder

Treatments: Biological: botulinum toxin Type A (200U); Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U); Biological: Normal saline (Placebo); botulinum toxin Type A (200U); Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575016

191622-518

Details and patient eligibility

About

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.

Enrollment: 74 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 4 patient groups

1

Experimental group

Description:

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

Treatment:

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

2

Experimental group

Description:

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

Treatment:

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

3

Experimental group

Description:

botulinum toxin Type A (200U)

Treatment:

Biological: botulinum toxin Type A (200U)

4

Other group

Description:

placebo; botulinum toxin Type A (200U)

Treatment:

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