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)
The Cleveland Clinic
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.
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 plac…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- OtherAt home removal
Removal of PNE lead at home
- OtherIn office removal
Removal of PNE lead in the office
Location
- Cleveland ClinicCleveland, Ohio