Status:
ACTIVE_NOT_RECRUITING
SPARC Bladder Mapping and Training Study
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health (NIH)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators propose to determine the electrode configurations that promote functional gains in the storage and voiding phases of lower urinary tract function as a result of activation of spinal ...
Detailed Description
Deficits in urologic function after spinal cord injury impact quality of life and consistently ranks as a top priority issue in the spinal cord injury population. Bladder dysfunction may manifest as d...
Eligibility Criteria
Inclusion
- stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate bladder training;
- clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation;
- non-progressive supra-sacral SCI (i.e., upper motor neuron re bladder circuitry);
- AIS classification A or B;
- at least 2 years post spinal cord injury.
Exclusion
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with mapping/training;
- Clinically significant depression or ongoing drug abuse;
- Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- Bladder Botox injections within the past year;
- Continent diversion procedures with or without bladder augmentation.
Key Trial Info
Start Date :
September 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03452007
Start Date
September 12 2018
End Date
December 31 2025
Last Update
December 13 2024
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202