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

Primary Purpose

Neurogenic Detrusor Overactivity

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Botulinum toxin A
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Detrusor Overactivity focused on measuring Neurogenic, Detrusor, Overactive, Overactivity, Bladder, Spinal, Cord, Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Outpatient, male or female subjects, of any race, between 18 and 75 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result on the day of Treatment (Visit 2) and practice a reliable method of contraception.
  2. Subjects with a neurogenic bladder and detrusor overactivity secondary to either a spinal cord injury or multiple sclerosis.
  3. Subjects with urinary incontinence (minimum of one occurrence per day) despite current treatment.
  4. Subjects with serum creatinine within normal limits and normal renal function.
  5. Subjects on a stable dose (minimum one month) of concomitant medication for NDO.
  6. Subjects able to understand the requirements of the study, including completing questionnaires and signing Informed Consent.

Exclusion Criteria

  1. Female subjects who are pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
  2. Subjects with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.
  3. Subjects with chronic indwelling catheters.
  4. Subjects with any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function.
  5. Subjects with an allergy or sensitivity to any component of BOTOX® (Section 5.2).
  6. Subjects unable to discontinue any agents that might interfere with neuromuscular function (i.e., aminoglycoside antibiotics, curare-like agents, etc.).
  7. Subjects with, in the opinion of the Investigator, unstable stable multiple sclerosis.
  8. Subjects with known, uncontrolled systemic disease.
  9. Subjects with evidence of recent alcohol/drug abuse.
  10. Subjects who, in the opinion of the Investigator, have a significant condition or situation that may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  11. Subjects with a history of poor cooperation, non-compliance, or unreliability.
  12. Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botulinum toxin A

Placebo

Arm Description

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

Sterile saline 30 cc injected into 30 sites in the bladder, sparing the trigone.

Outcomes

Primary Outcome Measures

Efficacy
Frequency of Incontinence Episodes over 3 days (3-Day Voiding Diary)

Secondary Outcome Measures

Efficacy
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

Full Information

First Posted
March 22, 2010
Last Updated
March 22, 2010
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
ethica Clinical Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01091727
Brief Title
Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
ethica Clinical Research Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Detrusor Overactivity
Keywords
Neurogenic, Detrusor, Overactive, Overactivity, Bladder, Spinal, Cord, Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum toxin A
Arm Type
Experimental
Arm Description
Botulinum toxin A 300U diluted with sterile saline (1 ml per injection site) and injected into 30 sites of the bladder, sparing the trigone.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile saline 30 cc injected into 30 sites in the bladder, sparing the trigone.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A
Other Intervention Name(s)
Botox
Intervention Description
Comparison of intra-detrusor injection of 300U of Botulinum toxin A versus placebo for effect on neurogenic detrusor overactivity and urinary incontinence.
Primary Outcome Measure Information:
Title
Efficacy
Description
Frequency of Incontinence Episodes over 3 days (3-Day Voiding Diary)
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Outpatient, male or female subjects, of any race, between 18 and 75 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result on the day of Treatment (Visit 2) and practice a reliable method of contraception. Subjects with a neurogenic bladder and detrusor overactivity secondary to either a spinal cord injury or multiple sclerosis. Subjects with urinary incontinence (minimum of one occurrence per day) despite current treatment. Subjects with serum creatinine within normal limits and normal renal function. Subjects on a stable dose (minimum one month) of concomitant medication for NDO. Subjects able to understand the requirements of the study, including completing questionnaires and signing Informed Consent. Exclusion Criteria Female subjects who are pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. Subjects with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty. Subjects with chronic indwelling catheters. Subjects with any medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis or any other disease that might interfere with neuromuscular function. Subjects with an allergy or sensitivity to any component of BOTOX® (Section 5.2). Subjects unable to discontinue any agents that might interfere with neuromuscular function (i.e., aminoglycoside antibiotics, curare-like agents, etc.). Subjects with, in the opinion of the Investigator, unstable stable multiple sclerosis. Subjects with known, uncontrolled systemic disease. Subjects with evidence of recent alcohol/drug abuse. Subjects who, in the opinion of the Investigator, have a significant condition or situation that may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. Subjects with a history of poor cooperation, non-compliance, or unreliability. Subjects currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Baseline Visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sender Herschorn, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

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

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