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

Phase 2TerminatedNCT00575016

Allergan74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overactive Bladder

Interventions

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

Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor

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

botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor

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

botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections 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 * 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

Locations (6)

Unnamed facility

Cairo, Egypt

Unnamed facility

Thessaloniki, Greece

Unnamed facility

Ahmadābād, India

Unnamed facility

Beirut, Lebanon

Unnamed facility

Belgrade, Serbia

Outcomes

Primary Outcomes

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).

Time frame: Baseline, Week 6

Secondary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Week 6

Data from ClinicalTrials.gov

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