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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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower). 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.
Primary Outcome
urethral sphincter pressure measured in response to presence of stimulation (treatment) compared to pressure in absence of stimulation
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 |
What the finished NCT05214378 record still lists
NCT05214378 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Finetech-Brindley Sacral Anterior Roots Stimulation System is the first listed.
NCT05214378 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05214378's enrollment target sits among peer trials
4 1922nd of 2000 higher than 53 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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