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

Phase 3

Terminated

• Conditions: Overactive Bladder
• Interventions: Biological: botulinum toxin Type A; Drug: Normal Saline (Placebo)

• Registration Number: NCT00439140
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-02-21
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-23
• Study Start: 2007-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Results First Submitted: 2013-12-09
• Results First Submitted QC: 2013-12-09
• Last Update Submitted: 2013-12-09
• Results First Posted: 2014-01-24
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A 200U	botulinum toxin Type A	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).
botulinum toxin Type A 300U	botulinum toxin Type A	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).
Placebo/botulinum toxin Type A 200U	botulinum toxin Type A	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).
Placebo/botulinum toxin Type A 200U	Normal Saline (Placebo)	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).
Placebo/botulinum toxin Type A 300U	botulinum toxin Type A	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).
Placebo/botulinum toxin Type A 300U	Normal Saline (Placebo)	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).

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)	Baseline, Week 6	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FEV1, the maximum amount of air exhaled in one second, at Baseline and Week 6. The highest value at each time-point was recorded. A positive change from Baseline indicated improvement.
Change From Baseline in Forced Vital Capacity (FVC)	Baseline, Week 6	Spirometry was conducted according to American Thoracic Society standards. A spirometer was used to measure FVC, the maximum amount of air exhaled from the lungs after taking the deepest breath possible, at Baseline and Week 6. A positive change from Baseline indicated improvement.
Change From Baseline in FEV1/FVC Ratio	Baseline, Week 6	The FEV1/FVC ratio was calculated by dividing the FEV1 value by the FVC value representing the portion (or ratio) of FVC exhaled in one second. A positive change from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Urinary Incontinence Episodes	Baseline, Week 6	The number of urinary incontinence episodes or leakage occurring over the previous 3 days was recorded in the patient bladder diary at Baseline and prior to Week 6. A negative change from Baseline indicated improvement (less incontinence/leakage).
Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)	Baseline, Week 6	MDP was measured at the first involuntary detrusor contraction using urodynamic testing. A catheter was inserted into the bladder at Baseline and Week 6 and the pressure \[measured in centimeters water (cm H20)\] was determined as the bladder filled. A negative change from Baseline indicated improvement (less Detrusor pressure).
Change From Baseline in Maximum Cystometric Capacity (MCC)	Baseline, Week 6	MCC (the maximum amount of urine the bladder could hold) was measured using urodynamic testing. The amount of urine collected was subtracted from the total volume infused measured as milliliters (mL) of urine. A positive change from Baseline indicated improvement (fuller bladder/ less incontinence).