NCT05900570

Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Corewell Health East · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study intra-urethral pressure data will be collected and analyzed with and without peri-urethral neurostimulation. This is a single arm feasibility study of women diagnosed with stress urinary incontinence. The data collected may help researchers have a better understanding of the effect, if any, on neurostimulation on stress or mixed urinary incontinence. After informed consent and all eligibility criteria are met, enrolled participants will be brought in for a stimulation visit. At the stimulation visit, participants will undergo urodynamic testing with and without stimulation. A prophylactic antibiotic will be given before the procedure and a local anesthetic cream will be applied topically to the peri-urethral area. The participant will be prepped for urodynamic testing per protocol. Commercially available simulation needles or leads and external neurostimulator device will be used to perform peri-urethral neurostimulation of the perineal branch of the pudendal nerve. The amplitude will gradually be increased and intra-urethral pressure will be recorded. Stimulation parameters such as amplitude, pulse-width, and frequency will be explored to assess their effect on urethral pressure. Amplitude progressively will be increased until discomfort is noted, no further pressure increases are observed, or maximum output is achieved. When a consistent pressure is observed, record intra-urethral pressure measurements with stimulation on and off. Next, Leak Point Pressure (LPP) testing with and without stimulation will be completed. Start the urodynamic saline infusion until desired volume is reached. Observe for urinary leakage. This will be repeated with the stimulation on.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-26
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2023-06-12
• Last updated: 2025-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study