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

Phase 3TerminatedNCT00439140

Allergan41 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overactive Bladder

Interventions

botulinum toxin Type ABIOLOGICAL

Botulinum toxin Type A injection into the detrusor.

Normal Saline (Placebo)DRUG

Placebo (Normal Saline) injection into the detrusor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Unnamed facility

Philadelphia, Pennsylvania, United States

Unnamed facility

Herston, Queensland, Australia

Unnamed facility

Victoria, British Columbia, Canada

Unnamed facility

Chennai, India

Outcomes

Primary Outcomes

Change From Baseline in Forced Vital Capacity (FVC)

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.

Time frame: Baseline, Week 6

Change From Baseline in Forced Expiratory Volume in One Second (FEV1)

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.

Time frame: Baseline, Week 6

Change From Baseline in FEV1/FVC Ratio

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.

Time frame: Baseline, Week 6

Secondary Outcomes

Change From Baseline in the Number of Urinary Incontinence Episodes

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).

Time frame: Baseline, Week 6

Change From Baseline in the Maximum (Amplitude) Detrusor Pressure (MDP)

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).

Data from ClinicalTrials.gov

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