Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Not Applicable

Recruiting

• Conditions: Blood Pressure; Autonomic Dysreflexia; Bowel Incontinence; Urinary Bladder, Neurogenic
• Interventions: Device: Spinal Cord Epidural Stimulation

• Registration Number: NCT04193709
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-10
• Study Start: 2021-01-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-01-03
• Study Completion: 2027-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiovascular spinal cord epidural stimulation	Spinal Cord Epidural Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)	Baseline, 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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean resting anal pressure after 80 sessions (6 months)	Baseline, 80 sessions (6 months)	Using anorectal manometry will will measure mean resting anal pressure in mmHg.
Change from baseline in bladder capacity after 80 sessions (6 months)	Baseline, 80 sessions (6 months)	Using urodynamics we will measure bladder capacity in mL
Change from baseline in mean squeeze pressure after 80 sessions (6 months)	Baseline, 80 sessions (6 months)	Using anorectal manometry we will measure mean squeeze pressure in mmHg.
Change from baseline in detrusor pressure after 80 sessions (6 months)	Baseline, 80 sessions (6 months)	Using urodynamics we will measure detrusor pressure in cmH2O.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States