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

This study has been completed.
Sponsor:
Collaborator:
ethica Clinical Research Inc.
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01091727
First received: March 22, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Neurogenic Detrusor Overactivity
Drug: Botulinum toxin A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    Frequency of Incontinence Episodes over 3 days (3-Day Voiding Diary)


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 57
Study Start Date: October 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: Botox
Placebo Comparator: Placebo
Sterile saline 30 cc injected into 30 sites in the bladder, sparing the trigone.
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.
Other Name: Botox

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091727

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
ethica Clinical Research Inc.
Investigators
Principal Investigator: Sender Herschorn, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sender Herschorn, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01091727     History of Changes
Other Study ID Numbers: 0922006
Study First Received: March 22, 2010
Last Updated: March 22, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Neurogenic
Detrusor
Overactive
Overactivity
Bladder
Spinal
Cord
Injury

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014