NCT05128682

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-07-27
• Completion: 2022-09-07
• First posted: 2021-11-22
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study