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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: Completed NA study, sponsored by MetroHealth Medical Center.
NCT05740527 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The closed-loop system has been designed to detect neurogenic bladder spasms (contractions) and to turn on a device to deliver genital nerve stimulation. Genital nerve stimulation has been shown previously to relax NDO bladder spasms and therefore allow for increased capacity, longer time between catheterization, and a reduction in incontinence episodes. The outcome for this feasibility trial will be the ability of the system to perform within expected parameters (\<5% false negative, \<10% fals
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 |
What the finished NCT05740527 record still lists
NCT05740527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which Noninvasive electrical stimulation of genital nerves is the first listed.
NCT05740527 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05740527's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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