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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
RECRUITINGThe effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.
Time frame: At stimulation visit, 1 day
Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.
Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported.
Time frame: One week after completing the stimulation visit
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation
Leak point pressure (measured in cmH20) will be collected during neurostimulation and without neurostimulation.
Time frame: At stimulation visit, 1 day
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