Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
NCT ID: NCT05900570
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-02-26
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Urodynamic testing and LLP with and without pudendal nerve stimulation
Commercially available stimulation needles or leads will be inserted into the peri-urethral space targeting the perineal branch of the pudendal nerve. An external neurostimulator settings will be adjusted to deliver acute stimulation. Urodynamic testing will be completed by filling the bladder to a set volume and observing for urinary leakage. The assessment will be completed with stimulation turned on and off. The neurostimulator device settings will be adjusted by the investigator to stay within safe and comfortable levels for each individual study participant.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Corewell Health East
OTHER
Responsible Party
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Kenneth M Peters, MD
Director and Chair of the Department of Urology
Principal Investigators
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Kenneth Peters, MD
Role: PRINCIPAL_INVESTIGATOR
Corewell Health William Beaumont University Hospital
Locations
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Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-117
Identifier Type: -
Identifier Source: org_study_id
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