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Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Primary Purpose

Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Epidural Stimulation
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Bladder, Neurogenic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Measure symptomatic indices of autonomic dysreflexia

Cardiovascular spinal cord epidural stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 monitor

Secondary Outcome Measures

Change from baseline in bladder capacity after 80 sessions (6 months)
Using urodynamics we will measure bladder capacity in mL
Change from baseline in detrusor pressure after 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)
Using anorectal manometry will will measure mean resting anal pressure in mmHg.
Change from baseline in mean squeeze pressure after 80 sessions (6 months)
Using anorectal manometry we will measure mean squeeze pressure in mmHg.

Full Information

First Posted
December 4, 2019
Last Updated
February 10, 2023
Sponsor
University of Louisville
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04193709
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
January 3, 2026 (Anticipated)
Study Completion Date
January 3, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Neurogenic, Blood Pressure, Autonomic Dysreflexia, Bowel Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross-sectional and observational (Arm 1) Prospective, cohort, and interventional (Arm 2).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Measure symptomatic indices of autonomic dysreflexia
Arm Type
No Intervention
Arm Description
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.
Arm Title
Cardiovascular spinal cord epidural stimulation
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Spinal Cord Epidural Stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)
Description
We will record systolic blood pressure every five minutes over a 24 hour period using a 24-hour blood pressure monitor
Time Frame
Baseline, 80 sessions (6 months)
Secondary Outcome Measure Information:
Title
Change from baseline in bladder capacity after 80 sessions (6 months)
Description
Using urodynamics we will measure bladder capacity in mL
Time Frame
Baseline, 80 sessions (6 months)
Title
Change from baseline in detrusor pressure after 80 sessions (6 months)
Description
Using urodynamics we will measure detrusor pressure in cmH2O.
Time Frame
Baseline, 80 sessions (6 months)
Title
Change from baseline in mean resting anal pressure after 80 sessions (6 months)
Description
Using anorectal manometry will will measure mean resting anal pressure in mmHg.
Time Frame
Baseline, 80 sessions (6 months)
Title
Change from baseline in mean squeeze pressure after 80 sessions (6 months)
Description
Using anorectal manometry we will measure mean squeeze pressure in mmHg.
Time Frame
Baseline, 80 sessions (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Hubscher, PhD
Phone
502-852-3058
Email
charles.hubscher@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Hubscher, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHARLES H HUBSCHER, PhD
Phone
502-852-3058
Email
CHHUBS01@LOUISVILLE.EDU

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

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