Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

University of Louisville (UOFL)

Status: Enrolling

Conditions: Urinary Bladder, Neurogenic; Bowel Incontinence; Autonomic Dysreflexia; Blood Pressure

Treatments: Device: Spinal Cord Epidural Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04193709

19.1194

OT2OD024898 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Measure symptomatic indices of autonomic dysreflexia

No Intervention group

Description:

The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.

Cardiovascular spinal cord epidural stimulation

Experimental group

Description:

The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.

Treatment:

Device: Spinal Cord Epidural Stimulation