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

Study Overview
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Brief Summary
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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.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Biological: Normal saline (Placebo); botulinum toxin Type A (200U)
* Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)
* Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)
* Biological: botulinum toxin Type A (200U)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>botulinum toxin Type A (50U); botulinum toxin Type A (200U) | Biological: botulinum toxin Type A (50U); botulinum toxin Type A (200U)<br>* botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor<br>* Other names: BOTOX®;|
| Experimental: 2<br>botulinum toxin Type A (100U); botulinum toxin Type A (200U) | Biological: botulinum toxin Type A (100U); botulinum toxin Type A (200U)<br>* botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor<br>* Other names: BOTOX®;|
| Experimental: 3<br>botulinum toxin Type A (200U) | Biological: botulinum toxin Type A (200U)<br>* botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor<br>* Other names: BOTOX®;|
| Other: 4<br>placebo; botulinum toxin Type A (200U) | Biological: Normal saline (Placebo); botulinum toxin Type A (200U)<br>* Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor<br>* Other names: BOTOX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). | Baseline, Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. | Baseline, Week 6 | 
| Change From Baseline in Maximum Detrusor Pressure (MDP) | Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. | Baseline, Week 6 |