NCT05900570 Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
| NCT ID | NCT05900570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corewell Health East |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2027-01 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 bladder cancer (currently undergoing or scheduled to undergo treatment for bladder cancer). * Previous radiation treatment in the pelvic floor * History or symptoms of cystocele, enterocele or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator * Current infection (urethritis, cystitis or vaginitis) as determined by investigator. * Active herpes genitalis * Unevaluated