NCT05900570 · Corewell Health East
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
What this study is about
The purpose of this early feasibility forward-looking study is to gain initial understanding of the effect of acute peri-urethral neurostimulation on the perineal nerves on intra-urethral pressure.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
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.
Primary outcome measures
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.
Time frame: At stimulation visit, 1 day
Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Royal Oak, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 11, 2025 · Source of record for eligibility and locations