MedTrace Logo

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

NCT05900570 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-11

No results posted yet for this study

Summary

The purpose of this early feasibility prospective study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.

Conditions

  • Stress Urinary Incontinence

Interventions

DIAGNOSTIC_TEST

Urodynamic testing with and without pudendal nerve stimulation

A urodynamic test with and without neurostimulation will be conducted. The external neurostimulator device settings will be adjusted to deliver acute nerve stimulation per the individual tolerance level to assess the effect on urethral pressure. A leak point pressure (LLP) during Valsalva maneuver will be assessed with and without acute nerve stimulation.

Sponsors & Collaborators

  • Corewell Health East

    lead OTHER

Principal Investigators

  • Kenneth Peters, MD · Corewell Health William Beaumont University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05900570 on ClinicalTrials.gov