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NCT05740527 · ClinicalTrials.gov registry record · NA
Ambulatory Closed-loop Stimulation for Bladder Control
A NA study, sponsored by MetroHealth Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
NCT05740527 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 7 participants.
The verdict
NCT05740527, a NA study, has completed, sponsored by MetroHealth Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
Study Summary
Individuals with spinal cord injury (SCI) develop neurogenic detrusor overactivity (NDO), resulting in urinary incontinence, decreased bladder capacity, and reduced quality of life. Current treatments incompletely address the problem and have unwanted side effects. Therefore, an alternative approach is needed. Electrical stimulation of the genital nerves (GNS) can inhibit NDO, improving bladder capacity and urinary continence. However, an automated closed-loop bladder feedback system, which currently does not exist, is necessary for individuals with SCI and NDO to utilize this therapy. The researchers have developed a custom algorithm to detect bladder contractions in real time, which requires only a bladder pressure signal. Our collaborators have developed a wireless, catheter-free bladder pressure sensor, called the UroMonitor, that was recently approved for testing in human participants. The goal of this project is to evaluate the potential feasibility and effectiveness of automated closed-loop GNS to inhibit unwanted bladder contractions using our custom algorithm and the wireless UroMonitor sensor. This project represents the next logical step toward improving or restoring bladder control using existing or emerging approaches to meet an important need for individuals with SCI. Successful completion of this project will motivate advancing a closed-loop approach using our custom algorithm and wireless bladder pressure sensor.
Interventions
- DEVICE Noninvasive electrical stimulation of genital nerves
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2024-10-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05740527
The ClinicalTrials.gov registry entry for NCT05740527 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Noninvasive electrical stimulation of genital nerves is the first listed.
NCT05740527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05740527 about?
NCT05740527 is a clinical study titled "Ambulatory Closed-loop Stimulation for Bladder Control". Individuals with spinal cord injury (SCI) develop neurogenic detrusor overactivity (NDO), resulting in urinary incontinence, decreased bladder capacity, and reduced quality of life. Current treatments incompletely address the problem and have unwanted side effects. Therefore, an alternative approach...
What is the current status of trial NCT05740527?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2021-03-01. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT05740527?
The interventions under investigation include: Noninvasive electrical stimulation of genital nerves (DEVICE).
Who is sponsoring clinical trial NCT05740527?
This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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