Overactive BladderSTIMNCT05799313
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
A study testing At home removal and In office removal in people with Overactive Bladder, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- At home removal and In office removal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years of age
- Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- At home removal, In office removal
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At home removalOther
Removal of PNE lead at home
In office removalOther
Removal of PNE lead in the office
| Study group | Role | What they receive |
|---|---|---|
| At home removal | Experimental | Not described Receives: Other: At home removal |
| In office removal | Active comparator | Not described Receives: Other: In office removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3-7 days
Secondary outcomes (7)
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)
Measured: 3-7 days
Patient discomfort with PNE trial overall
Patient reported discomfort with PNE trial overall on a scale of 0 (no discomfort) to 10 (most discomfort)
Measured: 3-7 days
Patient discomfort with PNE lead removal
Patient reported discomfort with PNE lead removal on a scale of 0 (no discomfort) to 10 (most discomfort)
Measured: 3-7 days
Patient inconvenience for PNE lead removal
Patient reported inconvenience for PNE lead removal on a scale of 0 (not inconvenient) to 10 (most inconvenient)
Measured: 3-7 days
Patient preference for PNE lead removal at home or in office
Patient choice of in office or at home
Measured: 3-7 days
Physician ease of PNE lead placement
Physician ease of PNE lead placement on a scale of 0 (very difficult) to 10 (very easy)
Measured: 1 day
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)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start7 Jun 2023
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Wallace, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799313
- Sponsor's protocol ID
- 22-1242
- Acronym
- STIM
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05799313
- Acronym / sponsor ID
- STIM / 22-1242
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At home removal | Experimental | Other: At home removal |
| In office removal | Active comparator | Other: In office removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years of age
- Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At home removalRemoval of PNE lead at home | Other | At home removal |
| In office removalRemoval of PNE lead in the office | Other | In office removal |
Primary outcome
Patient satisfaction between at home versus in office PNE lead removal
Time frame: 3-7 days
Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (most satisfied)
7 secondary outcomes
Patient percentage of improvement reported in urinary symptoms
Time frame: 3-7 days
Patient discomfort with PNE trial overall
Time frame: 3-7 days
Patient discomfort with PNE lead removal
Time frame: 3-7 days
Patient inconvenience for PNE lead removal
Time frame: 3-7 days
Patient preference for PNE lead removal at home or in office
Time frame: 3-7 days
Physician ease of PNE lead placement
Time frame: 1 day
Patient reported degree of pain of PNE lead placement
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Wallace, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At home removal and In office removal in people with Overactive Bladder, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction between at home versus in office PNE lead removal (time frame: 3-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.