Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

NCT04193709 | Completed DMC FDA Device

• 2 other identifiers: 19.1194 and 17.1024 BB-IS-2OT2OD024898
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 19.1194 Will determine change in systolic blood pressure during filling during cystometry

  We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments

  2 hours

• 19.1194 Will determine maximum change in systolic blood pressure during Anorectal Manometry assessments

  We will record systolic and diastolic blood pressure during Urodynamics and Anorectal manometry assessments

  1 hour

• 17.1024 BB-IS-2 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 monitorTime Frame: Baseline, 80 sessions (6 months)

  6 months

Secondary Outcomes (6)

• 19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments

  3 hours

• 19.1194 Will determine if level of injury, completeness of injury or gender have a significant effect on maximum changes in blood pressure

  5 years

• 17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months)

  6 months

• 17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months)

  6 months

• 17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months)

  6 months

Study Arms (2)

Measure symptomatic indices of autonomic dysreflexia

NO INTERVENTION

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

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.

Device: Spinal Cord Epidural Stimulation

Interventions

Spinal Cord Epidural Stimulation DEVICE

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).

Cardiovascular spinal cord epidural stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age;
• AIS A to D;
• Neurogenic bladder and bowel dysfunction;
• Stable medical condition
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Autonomic Dysreflexia; Fecal Incontinence

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Spinal Cord Injuries; Trauma, Nervous System; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Charles Hubscher, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 10, 2019
• Study Start: January 4, 2021
• Primary Completion: April 9, 2025
• Study Completion: April 24, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)