Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Spinal Cord Injury
Intervention
Oxybutynin Cl, Trospium Cl, Darifenacin HBr
Location
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto
Ontario
Canada
M4G 3V9
Status
Recruiting
Source
Toronto Rehabilitation Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00800462
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Spinal Cord Regeneration
Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.
Central Cord Syndrome
A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.
Spinal Cord Diseases
Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.
Spinal Cord Ischemia
Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.
Anterior Spinal Artery Syndrome
Ischemia or infarction of the spinal cord in the distribution of the anterior spinal artery, which supplies the ventral two-thirds of the spinal cord. This condition is usually associated with ATHEROSCLEROSIS of the aorta and may result from dissection of an AORTIC ANEURYSM or rarely dissection of the anterior spinal artery. Clinical features include weakness and loss of pain and temperature sensation below the level of injury, with relative sparing of position and vibratory sensation. (From Adams et al., Principles of Neurology, 6th ed, pp1249-50)
Clinical Trials
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
Safety and Preliminary Effectiveness of AV650 in Patients With Spasticity Due to Spinal Cord Injury
A drug called AV650 (tolperisone HCl) will be given to patients who have spasticity following a spinal cord injury. This study has three purposes: 1. To determine whether AV650 is safe...
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
Retraining Walking After Spinal Cord Injury
Incomplete spinal cord injury often results in difficulty walking. Training on a treadmill with body weight support may improve walking ability after spinal cord injury. The purpose of thi...
To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI). The researchers will investigate the ex...
PubMed Articles
Oxybutynin and trospium are substrates of the human organic cation transporters.
The muscarinic antagonists oxybutynin and trospium are used as spasmolytic agents for the treatment of overactive urinary bladder disease. Recently, it has been shown that trospium, but not oxybutynin...
ABSTRACT: BACKGROUND: Flexible dosing of anticholinergics used for overactive bladder (OAB) treatment is a useful strategy in clinical practice for achieving maximum effective and maximum tolerated le...
Study design:Retrospective cohort.Objectives:To estimate the association between the Functional Independence Measure (FIM) for spinal cord injury (SCI) patients at time of discharge from rehabilitatio...
Objective:To clarify the incidence and characteristics of spinal cord concussion in an urban city in Japan.Methods:The current retrospective study was conducted by reviewing the medical records of pat...
Treatment of experimental spinal cord injury with 3β-methoxy-pregnenolone.
The synthetic derivative of pregnenolone MAP4343 (3β-methoxy-pregnenolone) binds in vitro to microtubule-associated-protein 2 (MAP2), stimulates the polymerization of tubulin, enhances the extension...
