Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

Part of paid clinical trials in Royal Oak, Michigan.

Sponsor
Corewell Health East
Study ID
NCT05900570
Status
Recruiting
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Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Urodynamic testing with and without pudendal nerve stimulation — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Urodynamic testing and LLP with and without pudendal nerve stimulation
    Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.

Primary Outcome Measure

The effect of acute peri-urethral neurostimulation on intra-urethral pressure. [ Time Frame: At stimulation visit, 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corewell Health William Beaumont University HospitalRoyal OakMichigan48073
Jennifer Giordano, BSN
[email protected]
248-551-3517
Amanda Schonhoff, BSN
[email protected]
248-551-1225
Kenneth Peters, MD (PRINCIPAL_INVESTIGATOR)

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Corewell Health William Beaumont University Hospital· Royal Oak, MI

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