Actively Recruiting
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
Led by Corewell Health East · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years old or older
- Able to understand the study procedures and give informed consent
- Willing and able to undergo the study procedure
- Diagnosed with stress urinary incontinence or stress predominant mixed incontinence for at least 6 months
- Provided permission to use and disclose information for research purposes
You will not qualify if you...
- Predominant urge incontinence reported by patient or medical record
- Active uncontrolled bladder instability as decided by the investigator
- Regular or intermittent use of a urethral catheter
- Active bladder cancer or current treatment for bladder cancer
- Previous radiation treatment in the pelvic floor area
- History or symptoms of severe cystocele, enterocele, or rectocele (grade 3 or 4)
- Current infection such as urethritis, cystitis, or vaginitis
- Active genital herpes
- Unevaluated blood in urine
- Use of pharmacological treatment for stress urinary incontinence within 4 weeks prior to screening
- Severe or uncontrolled diabetes (hemoglobin A1c of 10% or higher)
- History of drug or alcohol abuse, mental dysfunction, or other factors limiting cooperation
- Positive pregnancy test during screening or currently breastfeeding
- Pregnant or given birth within the last 12 months
- Implanted active neurostimulators, pacemakers, or defibrillators that cannot be turned off for the procedure
- Known neurological disorders
- Severe coagulation disorders
- Medically unstable or unsafe for urodynamic testing
- Presence of an artificial urinary sphincter
- Any medical condition or uncontrolled chronic disease that affects ability to comply or safety as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
Research Team
J
Jennifer Giordano, BSN
CONTACT
A
Amanda Schonhoff, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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