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

NCT05128682 | Terminated Results FDA Device

• 1 other identifier: 2021-286
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

pudendal nerve; urinary incontinence

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Effect of Acute PNS on the Urethral Pressure Profile (UPP).

  After Visit 2 activities are complete. An average of 30 days after enrollment.

• Effect of Acute PNS on Max Cystometic Capacity.

  After Visit 2 activities are complete. An average of 30 days after enrollment.

• Effect of Acute PNS on Post Void Residual.

  After Visit 2 activities are complete. An average of 30 days after enrollment.

Study Arms (1)

Urodynamic testing with and without pudendal nerve stimulation

OTHER

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

Interventions

Urodynamic testing with and without pudendal nerve stimulation DIAGNOSTIC_TEST

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.

Urodynamic testing with and without pudendal nerve stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (2)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Beaumont Hospital Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

After the first 4 patients completed study activities, the investigator determined that this protocol is not the best way to test the study hypothesis due to uninterpretable data. Study was then terminated.

Results Point of Contact

• Title: Jennifer Giordano CRM
• Organization: Beaumont Hosptials

jennifer.giordano@corewellhealth.org

248-551-3517

Study Officials

• Kenneth Peters, MD

  Beaumont Hospital - Royal Oak

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Subjects who meet all eligibility criteria will be enrolled in the study and will undergo urodynamic testing with UPP.

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: November 22, 2021
• Study Start: May 24, 2022
• Primary Completion: July 27, 2022
• Study Completion: September 7, 2022
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)