Clinical trial NCT00800462: Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Official title: Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Cord Injury
Neurogenic Detrusor Overactivity
Lead sponsor: Toronto Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Ontario Neurotrauma Foundation
First posted: 2008-12-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Frequency of Incontinence Episodes
timeFrame: 3 days
measure: Adverse Event Reporting
timeFrame: Each Study Visit and Follow-up Phone Call
Secondary outcomes:
measure: Urodynamic Study
timeFrame: Baseline and 3 months
measure: Questionnaires
timeFrame: Monthly
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba, Health Sciences Centre
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute, Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Toronto Rehabilitation Institute
name: Magdy Hassouna, MD
role: PRINCIPAL_INVESTIGATOR
References: