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

William Beaumont Hospitals

Status: Terminated

Conditions: Urinary Incontinence

Treatments: Diagnostic Test: Urodynamic testing with and without pudendal nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05128682

2021-286

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Urodynamic testing with and without pudendal nerve stimulation

Other group

Description:

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.

Treatment:

Diagnostic Test: Urodynamic testing with and without pudendal nerve stimulation