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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04193709
Other study ID # 19.1194
Secondary ID OT2OD024898
Status Recruiting
Phase N/A
First received
Last updated
Start date January 4, 2021
Est. completion date January 3, 2027

Study information

Verified date March 2024
Source University of Louisville
Contact Charles Hubscher, PhD
Phone 502-852-3058
Email charles.hubscher@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date January 3, 2027
Est. primary completion date January 3, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


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).

Locations

Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline, 80 sessions (6 months)
Secondary Change from baseline in bladder capacity after 80 sessions (6 months) Using urodynamics we will measure bladder capacity in mL Baseline, 80 sessions (6 months)
Secondary Change from baseline in detrusor pressure after 80 sessions (6 months) Using urodynamics we will measure detrusor pressure in cmH2O. Baseline, 80 sessions (6 months)
Secondary 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. Baseline, 80 sessions (6 months)
Secondary Change from baseline in mean squeeze pressure after 80 sessions (6 months) Using anorectal manometry we will measure mean squeeze pressure in mmHg. Baseline, 80 sessions (6 months)
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