Comparing home and office removal of nerve leads for bladder treatment
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)
This study is testing whether women with overactive bladder feel more satisfied when their nerve leads are removed at home compared to having them taken out in a doctor's office.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05799313 on ClinicalTrials.gov |
What this trial studies
This study evaluates the satisfaction levels of women undergoing percutaneous nerve evaluation (PNE) for overactive bladder when the PNE lead is removed at home versus in a clinical office setting. Participants will be randomly assigned to one of the two removal methods after undergoing the PNE procedure. The study aims to determine if the method of lead removal affects patient satisfaction and overall experience with the PNE trial. Recruitment will occur at multiple Cleveland Clinic locations, and informed consent will be obtained prior to participation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are undergoing sacral neuromodulation for urinary urgency incontinence or urgency-frequency syndrome.
Not a fit: Patients who are unable to comprehend English, cannot provide informed consent, or lack home support for lead removal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more convenient and satisfactory option for lead removal, potentially improving their overall treatment experience.
How similar studies have performed: While there is limited data on the specific comparison of home versus office lead removal, similar studies in patient-centered care have shown positive outcomes in convenience and satisfaction.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Cecile A. Ferrando, M.D. — The Cleveland Clinic
- Study coordinator: Cecile A. Ferrando, M.D.
- Email: ferranc2@ccf.org
- Phone: 216-444-0642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.