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NCT05214378 · ClinicalTrials.gov registry record · Early Phase 1
High Frequency SARS for Neurogenic Bladder and Bowel Emptying
A Early Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
NCT05214378: Completed Early Phase 1 study, sponsored by VA Office of Research and Development.
NCT05214378 is a Early Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05214378, a Early Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if bladder emptying can be achieved using stimulation of the sacral roots at certain frequencies. Neurogenic bladder dysfunction occurs after spinal cord injury (SCI). It is a problem that often includes detrusor-sphincter-dyssynergia (DSD), which results in difficulty emptying the bladder due to reflex urethral sphincter contractions during bladder emptying. Individuals with DSD typically require a catheter to empty their bladder. Some people have received an implanted device that stimulates the spinal nerves that connect to the bladder to empty the bladder without a catheter. However, this procedure usually also includes cutting nerves to stop unwanted reflexes. For this study, the investigators are testing a new stimulation pattern to determine if it can help achieve bladder emptying without having to cut nerves. Individuals with SCI who have received an implanted sacral root stimulation device are being asked to participate in this research to test the effectiveness of electrical stimulation to relax the urethral sphincter and promote bladder emptying.
Interventions
- DEVICE Finetech-Brindley Sacral Anterior Roots Stimulation System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-07-01 |
| Est. Completion | 2024-07-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05214378
The ClinicalTrials.gov registry entry for NCT05214378 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Finetech-Brindley Sacral Anterior Roots Stimulation System is the first listed.
NCT05214378 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05214378 about?
NCT05214378 is a clinical study titled "High Frequency SARS for Neurogenic Bladder and Bowel Emptying". The purpose of this study is to determine if bladder emptying can be achieved using stimulation of the sacral roots at certain frequencies. Neurogenic bladder dysfunction occurs after spinal cord injury (SCI). It is a problem that often includes detrusor-sphincter-dyssynergia (DSD), which results in...
What is the current status of trial NCT05214378?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2022-07-01. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT05214378?
The interventions under investigation include: Finetech-Brindley Sacral Anterior Roots Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT05214378?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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