Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05799313
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-03-23
Brief Title:
Home Versus Office Removal of Percutaneous Nerve Evaluation PNE Lead
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Randomized Trial Comparing Home verSus In-office Removal of the percuTaneous Nerve evaluatIon Lead perforMed for the Treatment of Overactive Bladder in Women STIM Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STIM
Brief Summary:
For women undergoing percutaneous nerve evaluation PNE for the treatment of overactive bladder the first step is the PNE interstim therapy trial If the PNE works patients may opt to have the interstim procedure The purpose of this study is to see if patients who remove their PNE lead at home have the same satisfaction with the PNE trial as those women who have their lead removed in the office
Detailed Description:
Study Identification and Recruitment Potential subjects will be identified by members of the Center for Urogynecology Pelvic Reconstructive Surgery at the Cleveland Clinic Main campus Hillcrest Hospital Medina Hospital and Fairview Hospital Eligible patients who agree to participate will be provided written informed consent administered by the collaborators listed on this IRB Enrollment and consent will take place either at the time of office consultation prior to the procedure or virtually before the procedure using DocuSign
Randomization Randomization will occur prior to PNE placement Subjects will be randomized to either in-office versus at-home removal of the PNE lead Randomization will be done according to a computer-generated randomization schedule with the use of the SAS statistical software package SAS Institute Cary NC Subjects and research personnel will not be blinded to group allocation
Intervention PNE will be performed in a standard fashion with the patient placed in a flat prone position Her lower back will be prepped with antiseptics and she will be draped in sterile fashion Her coccyx is identified and an area 9cm cephalad to this point will be marked with a pen A line is then drawn 2 cm bilaterally in a horizontal fashion and points 2 cm cephalad to these points will also be marked to estimate the skin entry point for access into the S3 foramen Local anesthesia 1 lidocaine will be infiltrated bilaterally in the marked areas The PNE kit is opened and the foramen needle is inserted at an approximately 60 degree through one of the marked sites entering the presumed S3 foramen The S3 foraminal location is confirmed with any of the following responses levator ani motor response perirectal bellows plantar flexion of the ipsilateral great toe andor patient report of perineal sensation A second foramen needle is then placed on the contralateral side 4 cm away from the first needle also at a 60-degree angle into the S3 foramen Foraminal location is again confirmed with any of the following responses levator ani motor response perirectal bellows plantar flexion of the ipsilateral great toe andor patient report of perineal sensation Once the S3 foraminal location is confirmed the stylets are removed and the temporary leads are placed The leads are tested bilaterally and if similar responses are obtained bilaterally the procedure is complete The temporary leads are then taped securely to the skin with Tegaderm
PNE Lead Removal Patients will complete the trial within 3 to 7 days of the PNE lead being placed
At Home Removal Patients will receive a phone call day of removal by study personnel and they will be guided over the phone on how to remove the lead in real time If there is any question of complete lead removal they will be asked to upload a picture of their lead to their MyChart or they will text a picture of it to a Cleveland Clinic encrypted mobile phone belonging to one of the study personnel Confirmation of complete lead removal will be made and documented in the patients electronic medical record If there is any concern that the lead was not removed entirely the patient will be asked to come into the office for a visit and they will bring the removed lead with them
In Office Removal The temporary lead will be removed in the office at a scheduled visit by study personnel Confirmation of complete lead removal will be documented in the patients electronic medical record
Randomization Randomization will occur prior to PNE placement Subjects will be randomized to either in-office versus at-home removal of the PNE lead Randomization will be done according to a computer-generated randomization schedule with the use of the SAS statistical software package SAS Institute Cary NC Subjects and research personnel will not be blinded to group allocation
Intervention PNE will be performed in a standard fashion with the patient placed in a flat prone position Her lower back will be prepped with antiseptics and she will be draped in sterile fashion Her coccyx is identified and an area 9cm cephalad to this point will be marked with a pen A line is then drawn 2 cm bilaterally in a horizontal fashion and points 2 cm cephalad to these points will also be marked to estimate the skin entry point for access into the S3 foramen Local anesthesia 1 lidocaine will be infiltrated bilaterally in the marked areas The PNE kit is opened and the foramen needle is inserted at an approximately 60 degree through one of the marked sites entering the presumed S3 foramen The S3 foraminal location is confirmed with any of the following responses levator ani motor response perirectal bellows plantar flexion of the ipsilateral great toe andor patient report of perineal sensation A second foramen needle is then placed on the contralateral side 4 cm away from the first needle also at a 60-degree angle into the S3 foramen Foraminal location is again confirmed with any of the following responses levator ani motor response perirectal bellows plantar flexion of the ipsilateral great toe andor patient report of perineal sensation Once the S3 foraminal location is confirmed the stylets are removed and the temporary leads are placed The leads are tested bilaterally and if similar responses are obtained bilaterally the procedure is complete The temporary leads are then taped securely to the skin with Tegaderm
PNE Lead Removal Patients will complete the trial within 3 to 7 days of the PNE lead being placed
At Home Removal Patients will receive a phone call day of removal by study personnel and they will be guided over the phone on how to remove the lead in real time If there is any question of complete lead removal they will be asked to upload a picture of their lead to their MyChart or they will text a picture of it to a Cleveland Clinic encrypted mobile phone belonging to one of the study personnel Confirmation of complete lead removal will be made and documented in the patients electronic medical record If there is any concern that the lead was not removed entirely the patient will be asked to come into the office for a visit and they will bring the removed lead with them
In Office Removal The temporary lead will be removed in the office at a scheduled visit by study personnel Confirmation of complete lead removal will be documented in the patients electronic medical record
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None