Prospective Randomized Double-blind Trial of Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity and Urinary Incontinence Related to Spinal Cord Injury or Multiple Sclerosis

NCT01091727 Phase 3 COMPLETED

This is a prospective, multicentre (7 sites), randomized, double-blind, study comparing intravesical injection of BOTOX to placebo in 56 subjects with NDO secondary to spinal cord injury or multiple sclerosis. Study subjects will be randomized to one of the following two treatment groups: Group 1 n=28 BOTOX - 300U Group 2 n=28 Placebo BOTOX (saline) All study subjects will receive one injection cycle (BOTOX 300U or Placebo) at Visit 2 (Treatment, Day 0) as per Supplement III. The study duration is approximately 61 weeks and consists of a Pre-Treatment Evaluation, a Treatment/Randomization Visit (Visit 2, Day 0), Telephone Follow-ups at 1, 3 and 4 weeks post-treatment, and Follow-up Visits at 6, 24 and 36 weeks (Visits 3 to 5). At Week 36, subjects will be offered open-label BOTOX 300U and will be followed for an additional 6 months, returning for evaluations at Weeks 48 and 60.

Details

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 3
Status	COMPLETED
Enrolment	57
Start date	2006-10
Completion	2009-04

Conditions

• Neurogenic Detrusor Overactivity

Interventions

• Botulinum toxin A

Primary outcomes

• Efficacy — 36 weeks
  Frequency of Incontinence Episodes over 3 days (3-Day Voiding Diary)

Countries

Canada