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NCT05141487 · ClinicalTrials.gov registry record
Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder
A clinical trial of Urinary Incontinence and Urinary Bladder, Neurogenic, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- 16
- Enrollment target
- 1
- Study location
NCT05141487: Recruiting study of Urinary Incontinence and Urinary Bladder, Neurogenic, sponsored by VA Office of Research and Development.
NCT05141487 is a study of Urinary Incontinence and Urinary Bladder, Neurogenic that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 16 participants, below the 262-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05141487, a study of Urinary Incontinence and Urinary Bladder, Neurogenic, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Incontinence associates with military service and post-traumatic stress disorder in both male and female Veterans. Neurogenic detrusor overactivity (NDO) is caused by spinal cord injury or disorder, or peripheral neurodegenerative conditions, and causes urine leakage at low volumes. NDO is disproportionately experienced by Veterans and treatment effectiveness varies greatly between individuals. This project will demonstrate the feasibility of a new type of nerve stimulation-triggered sacral neuromodulation-to treat NDO in Veterans. A wireless bladder sensor will be inserted into the bladder to transmit a feedback signal enabling stimulation from a percutaneous lead. The wireless sensor will also measure NDO symptoms during simulated activities of daily living without catheters. Catheter-free detection of bladder activity will improve the outcomes of neuromodulation evaluations for Veterans with NDO. Future work could use the triggered neuromodulation system to study other methods of nerve stimulation to treat bladder, bowel, or sexual dysfunction.
Primary Outcome
Time between voids will be measured to determine change in conditional SNM response compared to baseline (no stimulation). Outcome will be measured from participant reporting and catheter- and device-referenced bladder pressures. For participant reporting (for example when voiding in a private bathroom) the clock time will be recorded and number of seconds from previous void will be recorded. For catheter- and device-referenced bladder pressures, the time between voids will be calculated manuall
Conditions Studied
Interventions
- DEVICE UroMonitor
- DEVICE ASCU
Study Locations (1)
Ohio
- Louis Stokes VA Medical Center, Cleveland, OH - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2026-10-30 |
What NCT05141487 shows while recruiting
NCT05141487 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 262-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which UroMonitor is the first listed.
NCT05141487 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05141487 about?
NCT05141487 is a clinical study titled "Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder". Incontinence associates with military service and post-traumatic stress disorder in both male and female Veterans. Neurogenic detrusor overactivity (NDO) is caused by spinal cord injury or disorder, or peripheral neurodegenerative conditions, and causes urine leakage at low volumes. NDO is dispropor...
What is the current status of trial NCT05141487?
This trial is currently recruiting. The enrollment target is 16 participants. The study started on 2022-10-03. Estimated completion is 2026-10-30.
What conditions does trial NCT05141487 study?
This clinical trial studies the following conditions: Urinary Incontinence, Urinary Bladder, Neurogenic.
What interventions are being tested in trial NCT05141487?
The interventions under investigation include: UroMonitor (DEVICE), ASCU (DEVICE).
Who is sponsoring clinical trial NCT05141487?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05141487 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05141487's enrollment target sits among peer trials
16 45th of 48 higher than 4 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
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