DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Toronto Rehabilitation Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Spinal Cord Injury; Neurogenic Detrusor Overactivity

Intervention: Oxybutynin Cl (Drug); Trospium Cl (Drug); Darifenacin Hydrogen Bromide (HBr) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Toronto Rehabilitation Institute

Official(s) and/or principal investigator(s):
Magdy Hassouna, MD, Principal Investigator, Affiliation: Toronto Rehabilitation Institute


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Frequency of Incontinence Episodes

Adverse Event Reporting

Secondary outcome:

Urodynamic Study



Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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.

Locations and Contacts

University of Manitoba, Health Sciences Centre, Winnipeg, Manitoba R3A1R9, Canada

Toronto Rehabilitation Institute, Lyndhurst Centre, Toronto, Ontario M4G 3V9, Canada

Additional Information

Ontario Neurotrauma Foundation

Starting date: March 2008
Last updated: April 4, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017