Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05128682
Status:
TERMINATED
Last Update Posted:
2023-05-16
First Post:
2021-09-22
Brief Title:
Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic Early Feasibility Study
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This is an early feasibility study After the first 4 patients completed study activities the investigator determined that this protocol is not the best way to test the study hypothesis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNS_UDT
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
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 discomfortdistress 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 patients 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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None