- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04193709
Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
March 19, 2024 updated by: Charles Hubscher, University of Louisville
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
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Charles Hubscher, PhD
- Phone Number: 502-852-3058
- Email: charles.hubscher@louisville.edu
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- Recruiting
- University of Louisville
-
Contact:
- CHARLES H HUBSCHER, PhD
- Phone Number: 502-852-3058
- Email: CHHUBS01@LOUISVILLE.EDU
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
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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.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, 80 sessions (6 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Baseline, 80 sessions (6 months)
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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.
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Baseline, 80 sessions (6 months)
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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.
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Baseline, 80 sessions (6 months)
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Change from baseline in mean squeeze pressure after 80 sessions (6 months)
Time Frame: Baseline, 80 sessions (6 months)
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Using anorectal manometry we will measure mean squeeze pressure in mmHg.
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Baseline, 80 sessions (6 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Charles Hubscher, PhD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2021
Primary Completion (Estimated)
January 3, 2026
Study Completion (Estimated)
January 3, 2027
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)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Gastrointestinal Diseases
- Intestinal Diseases
- Rectal Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Autonomic Nervous System Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
- Fecal Incontinence
- Autonomic Dysreflexia
Other Study ID Numbers
- 19.1194
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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