SPARC Bladder Mapping and Training Study
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|ClinicalTrials.gov Identifier: NCT03452007|
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : January 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Epidural Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Functional Mapping With Lumbosacral Epidural Stimulation for Restoration of Bladder Function After Spinal Cord Injury: Simulation-Based Modeling and Interactive Programming Integration for Bladder Home-Training|
|Actual Study Start Date :||September 12, 2018|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Bladder Mapping and Training
Individuals already implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle.
Device: Epidural Stimulation
Spinal cord epidural stimulation will be administered through a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord. An implanted package containing stimulating circuits, rechargeable battery, and wireless communication activates the electrodes (16 platinum electrodes arranged in three columns of [5-6-5]). The pattern of electrically active electrodes, as well as electrode voltage, stimulating frequency, and stimulating pulse width will be varied to facilitate effects toward bladder function.
- Changes in bladder capacity as assessed by urodynamics [ Time Frame: 2 years ]The quantitative metric for capacity will be the percent change in either residual volume (measured in ml) alone if no leak occurred or residual volume plus leak volume if a reflex void occurred upon reaching capacity.
- Changes in bladder pressure as assessed by urodynamics [ Time Frame: 2 years ]Percent change in maximum detrusor pressure (measured in cmH2O) will be recorded.
- Changes in voiding efficiency as assessed by urodynamics [ Time Frame: 2 years ]The quantitative metric for voiding will be the percent change in efficiency (leak volume divided by leak plus residual volumes).
- Changes in rectal squeeze pressure [ Time Frame: 2 years ]Percent change in amplitude as measured in cmH2O
- Changes in gastrointestinal motility [ Time Frame: 2 years ]Percent change in gut transit time as measured in hours.
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 ClinicalTrials.gov identifier (NCT number): NCT03452007
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Susan Harkema, PhD||University of Louisville|