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Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Recruiting
18 - 70 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Arm 1 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

Arms 1 and 2 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

Study details

Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia, Bowel Incontinence

NCT04193709

University of Louisville

27 January 2024

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