Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
STIM
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)
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedStudy Start
First participant enrolled
June 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 23, 2026
January 1, 2026
3.6 years
March 23, 2023
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
3-7 days
Secondary Outcomes (7)
Patient percentage of improvement reported in urinary symptoms
3-7 days
Patient discomfort with PNE trial overall
3-7 days
Patient discomfort with PNE lead removal
3-7 days
Patient inconvenience for PNE lead removal
3-7 days
Patient preference for PNE lead removal at home or in office
3-7 days
- +2 more secondary outcomes
Study Arms (2)
At home removal
EXPERIMENTALIn office removal
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 18 years of age
- Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cleveland Clinic
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecile A. Ferrando, M.D.
The Cleveland Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 5, 2023
Study Start
June 7, 2023
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share