Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

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 Overview

• Status: Completed
• Conditions: Blood Pressure; Urinary Bladder, Neurogenic; Autonomic Dysreflexia; Bowel Incontinence
• Intervention / Treatment: Device: Spinal Cord Epidural Stimulation

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Measure symptomatic indices of autonomic dysreflexia; 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.
Experimental: Cardiovascular 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.	Device: Spinal Cord Epidural Stimulation; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
19.1194 Will collect data on presence or absence of sensation during Urodynamics cystometry and Anorectal Manometry assessments	Will record participant's verbalized sensations while also measuring blood pressure 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	Will use multi-variable statistical analysis to determine significance	5 years
17.1024 BB-IS-2 Change from baseline in bladder capacity after 80 sessions (6 months)	Using urodynamics we will measure bladder capacity in mLTime Frame: Baseline, 80 sessions (6 months)	6 months
17.1024 BB-IS-2 Change from baseline in detrusor pressure after 80 sessions (6 months)	Using urodynamics we will measure detrusor pressure in cmH2O.Time Frame: Baseline, 80 sessions (6 months)	6 months
17.1024 BB-IS-2 Change from baseline in mean resting anal pressure after 80 sessions (6 months)	Using anorectal manometry will will measure mean resting anal pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months)	6 months
17.1024 BB-IS-2 Change from baseline in mean squeeze pressure after 80 sessions (6 months)	Using anorectal manometry we will measure mean squeeze pressure in mmHg.Time Frame: Baseline, 80 sessions (6 months)	6 months

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Charles Hubscher, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 24, 2026

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Trauma, Nervous System; Urinary Bladder Diseases; Autonomic Nervous System Diseases; Spinal Cord Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Neurogenic; Fecal Incontinence; Autonomic Dysreflexia
• Other Study ID Numbers: 19.1194 and 17.1024 BB-IS-2; OT2OD024898 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No