Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

NCT ID: NCT05799313

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-07
• Study Completion Date: 2026-12-31

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, 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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

At home removal

Group Type: EXPERIMENTAL

At home removal

Intervention Type: OTHER

Removal of PNE lead at home

In office removal

Group Type: ACTIVE_COMPARATOR

In office removal

Intervention Type: OTHER

Removal of PNE lead in the office

Interventions

At home removal

Removal of PNE lead at home

Intervention Type: OTHER

In office removal

Removal of PNE lead in the office

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age greater than or equal to 18 years of age
• Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome

Exclusion Criteria

• Inability to comprehend written and/or spoken English
• Inability to provide informed consent
• Patients undergoing SNM for other indications (e.g. urinary retention, fecal incontinence,)
• Previous SNM treatment
• No home support to assist with lead removal

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecile A. Ferrando, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cecile A. Ferrando, M.D.

Role: CONTACT

ferranc2@ccf.org

216-444-0642

Facility Contacts

Research Line

Role: primary

216-445-8090

Other Identifiers

22-1242

Identifier Type: -

Identifier Source: org_study_id