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Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193709
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : February 14, 2023
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Charles Hubscher, University of Louisville

Study Description
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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
Urinary Bladder, Neurogenic Blood Pressure Autonomic Dysreflexia Bowel Incontinence Device: Spinal Cord Epidural Stimulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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 : January 4, 2021
Estimated Primary Completion Date : January 3, 2026
Estimated Study Completion Date : January 3, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193709


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

Locations
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United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: CHARLES H HUBSCHER, PhD    502-852-3058    CHHUBS01@LOUISVILLE.EDU   
Sponsors and Collaborators
University of Louisville
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Charles Hubscher, PhD University of Louisville
More Information
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Responsible Party: Charles Hubscher, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT04193709    
Other Study ID Numbers: 19.1194
OT2OD024898 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Fecal Incontinence
Spinal Cord Injuries
Autonomic Dysreflexia
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Autonomic Nervous System Diseases
Neurologic Manifestations
 Urinary Bladder Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases