Corewell Health East
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 pro…
Inclusion Criteria: * Female aged 18 years old or older * Capable of understanding the clinical study procedures and giving informed consent * Willing and able to undergo the study procedure * Diagnosis of SUI or stress predominant mixed incontinence, for at least 6 months * Provided authorization to use and disclose information for research purposes Exclusion Criteria: * Predominant urge incontinence per patient report or medical record * Active symptomatic uncontrolled bladder instability as determined by the investigator * Regularly or intermittently used a urethral catheter * Active bla…
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.
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