Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead (STIM)
Primary Purpose
Overactive Bladder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
At home removal
In office removal
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
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
Sites / Locations
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
At home removal
In office removal
Arm Description
Outcomes
Primary Outcome Measures
Patient satisfaction between at home versus in office PNE lead removal
Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (most satisfied)
Secondary Outcome Measures
Patient percentage of improvement reported in urinary symptoms
Patient reported improvement in urinary symptoms on a scale of 0 (least improvement) to 100 (most improvement)
Patient discomfort with PNE trial overall
Patient reported discomfort with PNE trial overall on a scale of 0 (no discomfort) to 10 (most discomfort)
Patient discomfort with PNE lead removal
Patient reported discomfort with PNE lead removal on a scale of 0 (no discomfort) to 10 (most discomfort)
Patient inconvenience for PNE lead removal
Patient reported inconvenience for PNE lead removal on a scale of 0 (not inconvenient) to 10 (most inconvenient)
Patient preference for PNE lead removal at home or in office
Patient choice of in office or at home
Physician ease of PNE lead placement
Physician ease of PNE lead placement on a scale of 0 (very difficult) to 10 (very easy)
Patient reported degree of pain of PNE lead placement
Patient reported degree of pain of PNE lead placement on a scale of 0 (no pain) to 10 (most painful)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05799313
Brief Title
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
Acronym
STIM
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
At home removal
Arm Type
Experimental
Arm Title
In office removal
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
At home removal
Intervention Description
Removal of PNE lead at home
Intervention Type
Other
Intervention Name(s)
In office removal
Intervention Description
Removal of PNE lead in the office
Primary Outcome Measure Information:
Title
Patient satisfaction between at home versus in office PNE lead removal
Description
Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (most satisfied)
Time Frame
3-7 days
Secondary Outcome Measure Information:
Title
Patient percentage of improvement reported in urinary symptoms
Description
Patient reported improvement in urinary symptoms on a scale of 0 (least improvement) to 100 (most improvement)
Time Frame
3-7 days
Title
Patient discomfort with PNE trial overall
Description
Patient reported discomfort with PNE trial overall on a scale of 0 (no discomfort) to 10 (most discomfort)
Time Frame
3-7 days
Title
Patient discomfort with PNE lead removal
Description
Patient reported discomfort with PNE lead removal on a scale of 0 (no discomfort) to 10 (most discomfort)
Time Frame
3-7 days
Title
Patient inconvenience for PNE lead removal
Description
Patient reported inconvenience for PNE lead removal on a scale of 0 (not inconvenient) to 10 (most inconvenient)
Time Frame
3-7 days
Title
Patient preference for PNE lead removal at home or in office
Description
Patient choice of in office or at home
Time Frame
3-7 days
Title
Physician ease of PNE lead placement
Description
Physician ease of PNE lead placement on a scale of 0 (very difficult) to 10 (very easy)
Time Frame
1 day
Title
Patient reported degree of pain of PNE lead placement
Description
Patient reported degree of pain of PNE lead placement on a scale of 0 (no pain) to 10 (most painful)
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cecile A. Ferrando, M.D.
Phone
216-444-0642
Email
ferranc2@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecile A. Ferrando, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Line
Phone
216-445-8090
First Name & Middle Initial & Last Name & Degree
Marie Fidela R. Paraiso, M.D.
First Name & Middle Initial & Last Name & Degree
Shannon Wallace, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
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