NCT01091727

Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Neurogenic Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Botulinum toxin A	Comparison of intra-detrusor injection of 300U of Botulinum toxin A versus placebo for effect on neurogenic detrusor overactivity and urinary incontinence.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-03-24
• Last updated: 2010-03-24

Locations

1 site across 1 country: Canada