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

Allergan

Status and phase: Terminated; Phase 3

Conditions: Overactive Bladder

Treatments: Biological: botulinum toxin Type A; Drug: Normal Saline (Placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439140

191622-082

Details and patient eligibility

About

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Full description

Botulinum toxin Type A 300U has been discontinued from the study after regulatory approval of botulinum toxin Type A 200U. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Enrollment: 41 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.
• Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion criteria

• History or evidence of pelvic or urologic abnormality
• Previous or current diagnosis of bladder or prostate cancer
• Symptomatic or untreated 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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41 participants in 4 patient groups

botulinum toxin Type A 200U

Experimental group

Description:

Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Treatment:

Biological: botulinum toxin Type A

botulinum toxin Type A 300U

Experimental group

Description:

Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).

Treatment:

Biological: botulinum toxin Type A

Placebo/botulinum toxin Type A 200U

Other group

Description:

Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).

Treatment:

Drug: Normal Saline (Placebo)

Biological: botulinum toxin Type A

Placebo/botulinum toxin Type A 300U

Other group

Description:

Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 300U injection (200U after discontinuation of 300U) after a minimum of 12 weeks (if applicable).

Treatment:

Drug: Normal Saline (Placebo)

Biological: botulinum toxin Type A