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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-02-26 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 hematuria * Currently taking, or has taken within 4 weeks prior to the screening/baseline visit, pharmacological treatment for SUI (including but not limited to, alpha adrenergics, and tricyclic antidepressants) * Severe or uncontrolled diabetes, (defined as being a diabetic with a hemoglobin A1c of ≥10%) per patient medical record. * History of drug/alcohol abuse, mental dysfunction, or other factors limiting her ability to cooperate fully * Pregnancy test with positive result during screening or women who are breastfeeding * Women who are pregnant and/or have given birth in the previous 12 months * Have implanted active neurostimulators, pacemakers, or defibrillators; neurostimulators which are passive or that can be briefly turned off for the stimulation procedure are acceptable * Known systemic neurological dysfunctions * Severe coagulation disorders * Medically unstable at time of study and unsafe to undergo urodynamic testing (UDT) as determined by the investigator * Presence of an artificial urinary sphincter * Any medical condition (e.g. Multiple Sclerosis, spinal cord injury, mobility) or uncontrolled chronic disease (e.g. renal diseases that requires dialysis) that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
Contact & Investigator
Kenneth Peters, MD
PRINCIPAL INVESTIGATOR
Corewell Health William Beaumont University Hospital
Frequently Asked Questions
Who can join the NCT05900570 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05900570 currently recruiting?
Yes, NCT05900570 is actively recruiting participants. Contact the research team at Jennifer.Giordano@corewellhealth.org for enrollment information.
Where is the NCT05900570 trial being conducted?
This trial is being conducted at Royal Oak, United States.
Who is sponsoring the NCT05900570 clinical trial?
NCT05900570 is sponsored by Corewell Health East. The principal investigator is Kenneth Peters, MD at Corewell Health William Beaumont University Hospital. The trial plans to enroll 20 participants.