Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DEVICE superficial peroneal nerve stimulation

Study Locations (1)

Pennsylvania

  • UPMC Urology - Pittsburgh

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2019-12-20
Est. Completion 2024-12-30
Phase NA

Sponsor

Christopher J Chermansky, MD

3 total trials

What the Registry Record Tells You About NCT04000763

The ClinicalTrials.gov registry entry for NCT04000763 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 140-participant average among 11 other Urinary Retention trials with a reported enrollment target (99% lower). The listed sponsor is Christopher J Chermansky, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Similar trials for Urinary Retention

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.