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Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Sponsor
University of Louisville (Other)
Overall Status
Recruiting
CT.gov ID
NCT04193709
Collaborator
National Institutes of Health (NIH) (NIH)
70
Enrollment
1
Location
2
Arms
72
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spinal Cord Epidural Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Jan 3, 2026
Anticipated Study Completion Date :
Jan 3, 2027

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Louisville Louisville Kentucky United States 40202

Sponsors and Collaborators

  • University of Louisville
  • National Institutes of Health (NIH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Charles Hubscher, Professor, University of Louisville
ClinicalTrials.gov Identifier:
NCT04193709
Other Study ID Numbers:
  • 19.1194
First Posted:
Dec 10, 2019
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Fecal Incontinence
Spinal Cord Injuries
Autonomic Dysreflexia
Urinary Bladder, Neurogenic

Study Results

No Results Posted as of May 9, 2022