Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

N/ARecruitingNCT04193709

University of Louisville70 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Urinary Bladder, Neurogenic Blood Pressure Autonomic Dysreflexia Bowel Incontinence

Spinal Cord Epidural StimulationDEVICE

For arm 2, optimal stimulation parameters (cathode/anode configuration, stimulation frequency and voltage; placement of electrode from L1 to S1) will be identified for blood pressure and bladder pressure to achieve a bladder capacity in the target normative range of 400-450 mLs. Spinal cord epidural stimulation will then be used in a controlled lab setting for the regulation of blood pressure and heart rate to maintain normative values (target systolic pressure of 110-120 mmHg) and bladder pressure below 10 cmH2O during bladder filling up to the targeted capacity (fill volume of 400 mLs).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)

We will record systolic blood pressure every five minutes over a 24 hour period using a 24-hour blood pressure monitor