Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Jan 3, 2027
  • participants needed
    70
  • sponsor
    University of Louisville
Updated on 26 May 2022
spinal cord disorder
neurogenic bladder
autonomic dysreflexia

Summary

This study will incorporate critical cross viscero-visceral intersystem interactions to 1) investigate in a controlled laboratory setting and then with mobile at-home monitoring the extent, severity, and frequency of occurrence of autonomic dysreflexia with respect to daily bladder and bowel function, in conjunction with identifying potential underlying mechanisms by examining urinary biomarkers for several specific vasoactive hormones, and 2) to regulate cardiovascular function therapeutically as part of bladder and bowel management using spinal cord epidural stimulation.

Details
Condition Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia, Bowel Incontinence
Treatment Spinal Cord Epidural Stimulation
Clinical Study IdentifierNCT04193709
SponsorUniversity of Louisville
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

At least 18 years of age
AIS A to D
Neurogenic bladder and bowel dysfunction
Stable medical condition
Arm 2 Inclusion Criteria
At least 18 years of age
AIS A to D
Neurogenic bladder and bowel dysfunction
Use of intermittent catheterization for bladder emptying
Prior implantation of a Medtronic scES array

Exclusion Criteria

Prior Botox injections of the bladder and/or bladder augmentation surgery
Colostomy bag
Ventilator dependent
Any implanted pump (i.e. Baclofen pump, pain pump, etc.)
Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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