Actively Recruiting
The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure in Women with Stress Urinary Incontinence - Urodynamic Early Feasibility Study
Led by Corewell Health East · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand the effect of acute peri-urethral neurostimulation on intra-urethral pressure in women diagnosed with stress urinary incontinence or stress predominant mixed incontinence lasting at least six months. It is an early feasibility, single-arm study designed to explore how stimulating the perineal branch of the pudendal nerve might influence urethral pressure and leakage during bladder filling. This study is important for gaining initial insights into neurostimulation's potential impact on urinary incontinence symptoms. During the study, participants will have commercially available stimulation needles or leads placed in the peri-urethral area targeting the pudendal nerve. An external neurostimulator device will deliver acute stimulation, with settings such as amplitude, pulse-width, and frequency adjusted to each participant's comfort and safety. Urodynamic testing, including leak point pressure measurements during Valsalva maneuvers, will be performed both with and without neurostimulation. A prophylactic antibiotic and local anesthetic cream will be applied before testing to prepare the participant. Participants will attend a single stimulation visit where urodynamic testing and neurostimulation will be conducted. Researchers will collect and analyze intra-urethral pressure data during stimulation and non-stimulation phases, observing urinary leakage during bladder filling. Safety and tolerability will also be monitored for one week after the visit. The primary outcome is the change in intra-urethral pressure caused by neurostimulation, with additional measures including leak point pressure and adverse event tracking.
CONDITIONS
Brief Title
Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Able to understand study procedures and provide 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 authorization to use and disclose information for research purposes
You will not qualify if you...
- Predominant urge incontinence as reported by patient or medical records
- Uncontrolled bladder instability as determined by the investigator
- Regular or intermittent use of a urethral catheter
- Active bladder cancer or scheduled treatment for bladder cancer
- Previous pelvic floor radiation treatment
- History or symptoms of grade 3 or 4 cystocele, enterocele, or rectocele
- Current infection such as urethritis, cystitis, or vaginitis
- Active herpes genitalis
- Unevaluated hematuria
- Use of pharmacological treatment for stress urinary incontinence within 4 weeks prior to screening
- Severe or uncontrolled diabetes (HbA1c ≥10%)
- History of drug or alcohol abuse, mental dysfunction, or factors limiting ability to cooperate
- Positive pregnancy test or currently breastfeeding
- Pregnant or given birth within the past 12 months
- Implanted active neurostimulators, pacemakers, or defibrillators (passive or temporarily off neurostimulators allowed)
- Known systemic neurological dysfunctions
- Severe coagulation disorders
- Medically unstable or unsafe for urodynamic testing as per investigator
- Presence of an artificial urinary sphincter
- Medical conditions or uncontrolled diseases that interfere with protocol compliance or safety as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a single visit where urodynamic testing with and without peri-urethral neurostimulation is performed. The procedure includes application of local anesthetic cream, insertion of stimulation needles or leads, and adjustment of neurostimulator settings to assess intra-urethral pressure and leak point pressure.
1 visit (in-person)
Duration - 1 week
Participants are monitored for safety and tolerability, including any adverse events occurring after the stimulation visit.
Follow-up contact as needed
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
A
Amanda Schonhoff, BSN
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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