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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00800462
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : April 8, 2013
Ontario Neurotrauma Foundation
Information provided by (Responsible Party):
Magdy Hassouna, Toronto Rehabilitation Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Spinal Cord Injury Neurogenic Detrusor Overactivity Drug: Oxybutynin Cl Drug: Trospium Cl Drug: Darifenacin Hydrogen Bromide (HBr) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Frequency of Incontinence Episodes [ Time Frame: 3 days ]
  2. Adverse Event Reporting [ Time Frame: Each Study Visit and Follow-up Phone Call ]

Secondary Outcome Measures :
  1. Urodynamic Study [ Time Frame: Baseline and 3 months ]
  2. Questionnaires [ Time Frame: Monthly ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00800462

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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
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Principal Investigator: Magdy Hassouna, MD Toronto Rehabilitation Institute
Additional Information:
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Responsible Party: Magdy Hassouna, MD PhD FRCSC FACS, Toronto Rehabilitation Institute Identifier: NCT00800462    
Other Study ID Numbers: 2007-SCI-M3-488
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: April 8, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Overactive
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents