Effect of Peri-Urethral Stimulation on Intra-Urethral Pressure

NCT05900570 | Recruiting FDA Device

• 1 other identifier: 2023-117
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety and tolerability will be assessed in relation to the incidence of adverse events occurring within one week of stimulation visit.

  One week after completing the stimulation visit

• Valsalva leak point pressure (LLP) in response to acute peri-urethral neurostimulation compared to no stimulation

  At stimulation visit, 1 day

Study Arms (1)

Urodynamic testing and LLP with and without pudendal nerve stimulation

EXPERIMENTAL

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

Interventions

Urodynamic testing with and without pudendal nerve stimulation DIAGNOSTIC_TEST

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.

Urodynamic testing and LLP with and without pudendal nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Born female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Peters, MD

  Corewell Health William Beaumont University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Giordano, BSN

CONTACT

248-551-3517; Jennifer.Giordano@corewellhealth.org

Amanda Schonhoff, BSN

CONTACT

248-551-1225; Amanda.Schonhoff@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: Participants who meet all eligibility criteria will be enrolled in the study and undergo urodynamic testing and LPP with and without neurostimulation

Study Record Dates

• First Submitted: May 13, 2023
• First Posted: June 12, 2023
• Study Start: February 26, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)