Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Blood Pressure Clinical Trial

Official title:

Effects of Activity-Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193709
• Other study ID #: 19.1194
• Secondary ID: OT2OD024898
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Autonomic Dysreflexia
• Blood Pressure
• Bowel Incontinence
• Fecal Incontinence
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic

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)