Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

The Effect of Acute Peri-Urethral Neurostimulation on Intra-Urethral Pressure In Women With Stress Urinary Incontinence (SUI) - Urodynamic Early Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Diagnostic test: Urodynamic testing with and without pudendal nerve stimulation

Detailed Description

In this study intra-urethral pressure data will be collected and analyzed with and without peri-urethral neurostimulation. This is a single arm feasibility study of women diagnosed with stress urinary incontinence. The data collected may help researchers have a better understanding of the effect, if any, on neurostimulation on stress or mixed urinary incontinence. After informed consent and all eligibility criteria are met, enrolled participants will be brought in for a stimulation visit. At the stimulation visit, participants will undergo urodynamic testing with and without stimulation. A prophylactic antibiotic will be given before the procedure and a local anesthetic cream will be applied topically to the peri-urethral area. The participant will be prepped for urodynamic testing per protocol. Commercially available simulation needles or leads and external neurostimulator device will be used to perform peri-urethral neurostimulation of the perineal branch of the pudendal nerve. The amplitude will gradually be increased and intra-urethral pressure will be recorded. Stimulation parameters such as amplitude, pulse-width, and frequency will be explored to assess their effect on urethral pressure. Amplitude progressively will be increased until discomfort is noted, no further pressure increases are observed, or maximum output is achieved. When a consistent pressure is observed, record intra-urethral pressure measurements with stimulation on and off. Next, Leak Point Pressure (LPP) testing with and without stimulation will be completed. Start the urodynamic saline infusion until desired volume is reached. Observe for urinary leakage. This will be repeated with the stimulation on.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Giordano, BSN; Phone Number: 248-551-3517; Email: Jennifer.Giordano@corewellhealth.org
• Study Contact Backup: Name: Amanda Schonhoff, BSN; Phone Number: 248-551-1225; Email: Amanda.Schonhoff@corewellhealth.org

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Corewell Health William Beaumont University Hospital
      • Principal Investigator: Kenneth Peters, MD
      • Contact: Jennifer Giordano, BSN; Phone Number: 248-551-3517; Email: Jennifer.Giordano@corewellhealth.org
      • Contact: Amanda Schonhoff, BSN; Phone Number: 248-551-1225; Email: Amanda.Schonhoff@corewellhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of acute peri-urethral neurostimulation on intra-urethral pressure.	Intra-urethral pressure (measured in cmH2O) will be recorded with stimulation on and off.	At stimulation visit, 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation	Leak point pressure (measured in cmH20) will be collected during neurostimulation and without neurostimulation.	At stimulation visit, 1 day
Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.	Safety and tolerability of peri-urethral stimulation will be assessed in related to the incidence of adverse events reported.	One week after completing the stimulation visit

Collaborators and Investigators

• Sponsor: Corewell Health East
• Investigators: Principal Investigator: Kenneth Peters, MD, Corewell Health William Beaumont University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress
• Other Study ID Numbers: 2023-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes