Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT04193709
• Recruitment Status: Recruiting
• First Posted: December 10, 2019
• Last Update Posted: February 14, 2023
• Sponsor: University of Louisville
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Charles Hubscher, University of Louisville

Tracking Information

• First Submitted Date: December 4, 2019
• First Posted Date: December 10, 2019
• Last Update Posted Date: February 14, 2023
• Actual Study Start Date: January 4, 2021
• Estimated Primary Completion Date: January 3, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 6, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 6, 2019)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
• Official Title: Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Other

Condition

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

Intervention

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).

Study Arms

• 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.
  Intervention: Device: Spinal Cord Epidural Stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 3, 2020): 70
• Original Estimated Enrollment (submitted: December 6, 2019): 67
• Estimated Study Completion Date: January 3, 2027
• Estimated Primary Completion Date: January 3, 2026 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Charles Hubscher, PhD; 502-852-3058; charles.hubscher@louisville.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04193709
• Other Study ID Numbers: 19.1194; OT2OD024898 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Charles Hubscher, University of Louisville
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Louisville
• Original Study Sponsor: Same as current
• Collaborators: National Institutes of Health (NIH)

Investigators

• Principal Investigator: Charles Hubscher, PhD; University of Louisville

• PRS Account: University of Louisville
• Verification Date: February 2023