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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
4
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.
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States
Beaumont Hospital Royal Oak
Royal Oak, Michigan, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.
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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).
Time frame: 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.
Time frame: 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.
Time frame: After Visit 2 activities are complete. An average of 30 days after enrollment.