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

Phase 3

Completed

• Conditions: Neurogenic Detrusor Overactivity
• Interventions: Drug: Botulinum toxin A

• Registration Number: NCT01091727
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief 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.

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-03
• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin A	Botulinum toxin A	Botulinum toxin A 300U diluted with sterile saline (1 ml per injection site) and injected into 30 sites of the bladder, sparing the trigone.
Placebo	Botulinum toxin A	Sterile saline 30 cc injected into 30 sites in the bladder, sparing the trigone.

Primary Outcome Measures

Name	Time	Method
Efficacy	36 weeks	Frequency of Incontinence Episodes over 3 days (3-Day Voiding Diary)

Secondary Outcome Measures

Name	Time	Method
Efficacy	36 weeks	Maximum Detrusor Pressure During Filling;Volume at Maximum Detrusor Pressure During Filling at 6 Wks;Volume at Maximum Detrusor Pressure During Filling other than at 6 Wks;Reflex Detrusor Volume at First Contraction; Maximal Bladder Capacity;Frequency of micturition; Bladder Compliance;ICIQ,DBICI,I-QOL Incontinence intervals, number of pads used, amount leaked, degree of urgency Intermittent Catheterizations;Urine volume obtained during catheterization Timing and reduction or cessation of anticholinergic medication

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada