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NCT04000763 · ClinicalTrials.gov registry record · NA
Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention
A NA study of Urinary Retention and Urinary Bladder, Underactive, sponsored by Christopher J Chermansky, MD.
- Completed
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT04000763: Completed NA study of Urinary Retention and Urinary Bladder, Underactive, sponsored by Christopher J Chermansky, MD.
NCT04000763 is a NA study of Urinary Retention and Urinary Bladder, Underactive that has completed, run by Christopher J Chermansky, MD. The registered enrollment target is 2 participants, below the 140-participant average among 11 other Urinary Retention trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04000763, a NA study of Urinary Retention and Urinary Bladder, Underactive, has completed, sponsored by Christopher J Chermansky, MD.
- COMPLETED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling suprapubic catheter. Currently an effective drug for non-obstructive urinary retention does not exist. It is a therapeutic challenge for clinicians to successfully treat non-obstructive urinary retention. Sacral neuromodulation has been approved by the FDA since 1999 to treat non-obstructive urinary retention. It achieves \>50% improvement in bladder emptying (reducing the frequency of self-catheterization or increasing voided volume) in just over half of the patients. Sacral neuromodulation requires surgical implantation of a stimulator and a lead with 4 electrodes. The surgery and implant are invasive and expensive, preventing a broad application of this effective therapy to many non-obstructive urinary retention patients. The goal of this study is to develop a novel non-invasive neuromodulation therapy for non-obstructive urinary retention as an alternative. Specifically, the investigators will explore the possibility to translate into humans a recent discovery in cats of an excitatory reflex from the superficial peroneal nerve to the bladder to treat non-obstructive urinary retention. Therefore, in this study the investigators propose to develop a non-invasive, transcutaneous neuromodulation therapy for non-obstructive urinary retention that can be administered at home.
Primary Outcome
Counted using a patient voiding diary both before and after superficial peroneal nerve stimulation.
Conditions Studied
Interventions
- DEVICE superficial peroneal nerve stimulation
Study Locations (1)
Pennsylvania
- UPMC Urology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2024-12-30 |
| Phase | NA |
What the finished NCT04000763 record still lists
NCT04000763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 140-participant average among 11 other Urinary Retention trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Urinary Retention appearing as the primary indexed condition, and to 1 intervention - of which superficial peroneal nerve stimulation is the first listed.
NCT04000763 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04000763 about?
NCT04000763 is a clinical study titled "Superficial Peroneal Nerve Neuromodulation for Non-Obstructive Urinary Retention". Millions of Americans are suffering from underactive bladder (UAB). The impact of severe UAB, i.e. non-obstructive urinary retention (NOUR) on quality of life is significant because current treatment for non-obstructive urinary retention requires intermittent self-catheterization or an indwelling su...
What is the current status of trial NCT04000763?
This trial is currently completed. It is a NA study. The enrollment target is 2 participants. The study started on 2019-12-20. Estimated completion is 2024-12-30.
What conditions does trial NCT04000763 study?
This clinical trial studies the following conditions: Urinary Retention, Urinary Bladder, Underactive.
What interventions are being tested in trial NCT04000763?
The interventions under investigation include: superficial peroneal nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT04000763?
This trial is sponsored by Christopher J Chermansky, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04000763 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04000763's enrollment target sits among peer trials
2 12th of 11 the lowest of 11 other Urinary Retention trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Retention 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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