Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study (PNS_UDT)

The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic: Early Feasibility Study

The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve.

Study Overview

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

Detailed Description

Patients with a neurostimulator implanted at the pudendal nerve will be enrolled and undergo urodynamic testing. Before testing, study staff will provide an oral antibiotic (to reduce the risk of infection) and adjust the stimulation settings with a goal to increase urethral pressure from baseline by at lest 20cm H2O, without causing the patient discomfort/distress. These settings will be used throughout urodynamics. Before filling the bladder, a urethral pressure profile study will be completed 3 times with stimulation off, then 3 times with stimulation on. Leak point pressure (LPP) testing will then be completed. The patient's bladder will be filled following standard urodynamic testing protocol. Filling will be paused every 50-100mL to complete LPP assessment. Subjects will be asked to complete a light cough, medium cough, forceful cough, and Valsalva maneuver (in that order). Detrusor pressure will be measured at each event, and staff will document whether or not a leak was elicited. This will be completed with stimulation off, then with stimulation on, as the bladder is filled. Once the subject reports a strong urge to void, urethral pressure profile assessment will be completed again: 3 times with stimulation off, then 3 times with stimulation on. Once urodynamic testing is complete and the patient's bladder is emptied, a measurement of urethral pressure will be completed with stimulation off, then during 5 seconds of stimulation, then again with stimulation off.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital - Royal Oak
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital Royal Oak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women between the ages of 18 and 85 years old, inclusive.
• Implanted with a neurostimulation device for at least 3 months prior to consent (Medtronic Interstim neurostimulator models 3023, 3058, 97810, or similar).
• Implanted with a tined lead that is placed and functionable at the pudendal nerve (Medtronic model 3889 or similar).
• Is capable of understanding clinical study procedures and giving informed consent.
• Willing and able to visit the clinic for the UDT evaluation (study procedure)

Exclusion Criteria:

• Medically unstable at time of study and unsafe to undergo urodynamic testing as determined by the investigator.
• History of bladder cancer.
• History of pelvic radiotherapy.
• Active gross hematuria.
• Active symptomatic urinary tract infection (UTI)
• Active symptomatic uncontrolled bladder instability as determined by the investigator.
• History or symptoms of cystocele, enterocele, or rectocele of grade 3 or 4. Per the medical record or as determined by the investigator.
• Presence of an artificial urinary sphincter.
• Women who are pregnant and/or have given birth in the previous 12 months
• Any medical condition 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
• BMI greater than 39.

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

Other: Urodynamic testing with and without pudendal nerve stimulation; The neuromodulation settings of the implanted device will be adjusted to deliver acute simulation. Urodynamic testing (UDT) will be completed by filling the bladder and observing for urinary leakage. The assessment will be completed with the stimulation sets turned off and then turned on. At the end of the UDT the settings will be returned to the previously set therapeutic values. The neuromodulation settings constitute the "dose" and can include the voltage/current amplitude, frequency, pulse width, on time/off time duration and electrode polarity assignments. These parameters are limited by the available ranges of the approved neurostimulation device and will be adjusted during the study by the principal investigator to stay within the safe and comfortable levels for each individual study subject.

Diagnostic test: Urodynamic testing with and without pudendal nerve stimulation; A urodynamic test (UDT) for eligible subjects with and without acute PNS will be conducted. Prior to introducing the acute PNS, the subject's original stimulation properties will be turned off. The implanted neurostimulator device will be programmed to deliver acute PNS per individual tolerance level with the objective of increasing external urethral sphincter pressure. The LPP during Valsalva maneuver or forceful coughing will be assessed with and without acute PNS. The LPP will be assessed at increasing bladder volumes until major detrusor instability, significant leakage (more than drops, stream) or subject discomfort (strong desire to void) is observed. Finally, a UPP with PNS set in an on/off cycling regimen will be conducted to observe the effect on pressures along the length of the urethra.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.	PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.	After Visit 2 activities are complete. An average of 30 days after enrollment.
Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.	PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation.	After Visit 2 activities are complete. An average of 30 days after enrollment.
Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.	PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation.	After Visit 2 activities are complete. An average of 30 days after enrollment.
Identification of All Study-related Adverse Events	Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported.	After Visit 2 activities are complete. An average of 30 days after enrollment.
Changes in Leak Point Pressure (LPP) Upon Acute PNS	Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water.	After Visit 2 activities are complete. An average of 30 days after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of Acute PNS on the Urethral Pressure Profile (UPP).	Measure the maximum urethral closure pressure with and without programmed pudendal nerve stimulation. In cm water. Urethral pressure profile is a test of the bladder neck, urethra, and urethral sphincters that is completed with urodynamic equipment. A small catheter is pulled at a constant rate from the bladder neck down the urethra to provide the functional length of the urethra and points of maximal urethral resistance at the urethral sphincter. It is a procedure used to measure the competency of the urethral sphincter (outflow resistance).	After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Max Cystometic Capacity.	Max cystometic capacity will be collected, with and without programmed PNS, the difference will be reported. In mL.	After Visit 2 activities are complete. An average of 30 days after enrollment.
Effect of Acute PNS on Post Void Residual.	Post void residual collected at end of UDT testing. Measured in mL.	After Visit 2 activities are complete. An average of 30 days after enrollment.

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Kenneth Peters, MD, Beaumont Hospital - Royal Oak

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Actual): July 27, 2022
• Study Completion (Actual): September 7, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: urinary incontinence; pudendal nerve
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: 2021-286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes