Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

This study has been completed.
Sponsor:
Collaborator:
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Magdy Hassouna, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT00800462
First received: December 1, 2008
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals with spinal cord injury.


Condition Intervention Phase
Spinal Cord Injury
Neurogenic Detrusor Overactivity
Drug: Oxybutynin Cl
Drug: Trospium Cl
Drug: Darifenacin Hydrogen Bromide (HBr)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • Frequency of Incontinence Episodes [ Time Frame: 3 days ] [ Designated as safety issue: No ]
  • Adverse Event Reporting [ Time Frame: Each Study Visit and Follow-up Phone Call ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Urodynamic Study [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: Yes ]
  • Questionnaires [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2008
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxybutynin Cl Drug: Oxybutynin Cl
15 mg qd for 3 months
Other Name: Uromax
Active Comparator: Trospium Cl Drug: Trospium Cl
20mg bid for 3 months
Other Name: Trosec
Active Comparator: Darifenacin Hydrogren Bromide (HBr) Drug: Darifenacin Hydrogen Bromide (HBr)
15 mg qd for 3 months
Other Name: Enablex

  Eligibility

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

Inclusion Criteria:

  1. Male or female patients, between 18 and 75 years of age. Female patients of childbearing potential* must have a negative urine pregnancy test result on the day of Screening Visit and practice a reliable method of contraception**

    *A female is considered of childbearing potential unless she is:

    • Postmenopausal for at least 12 months prior to study drug administration;
    • Without a uterus and/or both ovaries; or
    • Has been surgically sterilized for at least 6 months prior to study drug administration.

      **Reliable methods of contraception include:

    • Hormonal methods or intrauterine device in use at least 30 days prior to study drug administration;
    • Barrier methods plus spermicidal in use at least 14 days prior to study drug administration; or
    • Sexual abstinence as a lifestyle.
  2. Patients with a neurogenic bladder and detrusor overactivity secondary to a spinal cord injury.

    • Patients with urinary incontinence (minimum of one occurrence per day) despite current treatment. [NOTE: Bladder emptying may be accomplished with straining, intermittent catheterization (IC), spontaneous micturition or leakage episodes.]
  3. Patients with serum creatinine within normal limits and normal renal function
  4. Patients on a stable dose (minimum one month) of concomitant medication for Neurogenic detrusor overactivity
  5. Patients must have adequate cognitive function to understand the requirements of the study, including completing questionnaires and signing a written Informed Consent.

Exclusion Criteria:

  1. Female patients who are pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
  2. Patients with a history of transurethral sphincterotomy, bladder neck or prostatic resection, previous bladder surgery including myomectomy or augmentation cystoplasty.
  3. Patients with chronic indwelling catheters.
  4. Patients with, in the opinion of the Investigator, unstable or stable multiple sclerosis.
  5. Patients with known, uncontrolled systemic disease.
  6. Patients with evidence of recent alcohol/drug abuse.
  7. Patients with urinary retention, gastrointestinal obstructive disorders or uncontrolled narrow-angle glaucoma.
  8. Patients with contraindications to Trosec™, Enablex™ and Uromax®.
  9. Patients who, in the opinion of the Investigator, have a significant condition or situation that may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
  10. Patients with a history of poor cooperation, non-compliance, or unreliability.
  11. Patients currently participating in an investigational drug study or who have participated in an investigational drug study within 30 days of the Screening Visit.
  12. Patients administered anticholinergics and/or antispasmodic drugs during the course of the study.
  13. Patient with hepatic insufficiency.
  14. Patient has been administered intravesical botulinum toxin within 6 months prior to the Screening Visit and/or is expected to receive intravesical botulinum toxin during the course of the study.
  15. Patient has any medical condition that would interfere with the interpretation of the study results or the conduct of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800462

Locations
Canada, Manitoba
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A1R9
Canada, Ontario
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Sponsors and Collaborators
Toronto Rehabilitation Institute
Ontario Neurotrauma Foundation
Investigators
Principal Investigator: Magdy Hassouna, MD Toronto Rehabilitation Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Magdy Hassouna, MD PhD FRCSC FACS, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT00800462     History of Changes
Other Study ID Numbers: 2007-SCI-M3-488
Study First Received: December 1, 2008
Last Updated: April 4, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Bromides
Trospium chloride
Oxybutynin
Darifenacin
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on April 14, 2014