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Spinal Cord Epidural Stimulation for Neurogenic Bladder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neurogenic Bladder+3 MoreSpinal Cord Epidural Stimulation - Device
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well a new treatment for autonomic dysreflexia works in people with spinal cord injuries.

Eligible Conditions
  • Neurogenic Bladder
  • Bowel Incontinence
  • Autonomic Dysreflexia
  • High Blood Pressure

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 80 sessions (6 months)

Month 6
Change from baseline in bladder capacity after 80 sessions (6 months)
Change from baseline in detrusor pressure after 80 sessions (6 months)
Change from baseline in mean resting anal pressure after 80 sessions (6 months)
Change from baseline in mean squeeze pressure after 80 sessions (6 months)
Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Sildenafil Citrate
2
High dosage
1
Mild Intermittent Hypoxia

Trial Design

2 Treatment Groups

Measure symptomatic indices of autonomic dysreflexia
1 of 2
Cardiovascular spinal cord epidural stimulation
1 of 2

Active Control

Experimental Treatment

70 Total Participants · 2 Treatment Groups

Primary Treatment: Spinal Cord Epidural Stimulation · No Placebo Group · N/A

Cardiovascular spinal cord epidural stimulation
Device
Experimental Group · 1 Intervention: Spinal Cord Epidural Stimulation · Intervention Types: Device
Measure symptomatic indices of autonomic dysreflexiaNoIntervention Group · 1 Intervention: Measure symptomatic indices of autonomic dysreflexia · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 80 sessions (6 months)

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,442 Previous Clinical Trials
24,578,208 Total Patients Enrolled
University of LouisvilleLead Sponsor
314 Previous Clinical Trials
72,870 Total Patients Enrolled
Charles Hubscher, PhDPrincipal Investigator - University of Louisville
University of Louisville
1 Previous Clinical Trials
6 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Intermittent catheterization is a procedure that involves the insertion of a catheter through the urethra into the bladder to empty the urine
is not required Before implanting a Medtronic scES array, it is not necessary to do a previous implantation.
At least 18 years of age is required.
problems with controlling the bladder and bowel due to damage to the nervous system.
A stable medical condition is one that does not worsen over time.
References

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