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, and/or 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, and/or 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 patient's 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
patient's electronic medical record.