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

Condition(s) targeted: Overactive Bladder

Intervention: botulinum toxin Type A (Biological); botulinum toxin Type A (Biological); placebo/Botulinum Toxin Type A (Biological); Placebo/botulinum toxin Type A (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Allergan

Overall contact:
Allergan Inc., Email: clinicaltrials@allergan.com

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.

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Forced Vital Capacity

Forced Expiratory Volume

Secondary outcome:

Pulmonary function

Number of episodes of urinary incontinence (urodynamics)

Peak (amplitude) detrusor pressure (urodynamics)

Maximum cystometric capacity (urodynamics)

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Allergan Inc., Email: clinicaltrials@allergan.com

Nimes Cedex, France; Recruiting

Bangalore, India; Recruiting

Amsterdam, Netherlands; Recruiting

Edmonton, Alberta, Canada; Recruiting

Hines, Illinois, United States; Recruiting

Brisbane, Queensland, Australia; Recruiting

Starting date: June 2007
Ending date: December 2011
Last updated: May 5, 2009