RecruitingNot ApplicableNCT05799313

Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead

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)


Sponsor

The Cleveland Clinic

Enrollment

30 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Age greater than or equal to 18 years of age
  • Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome

Exclusion Criteria5

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERAt home removal

Removal of PNE lead at home

OTHERIn office removal

Removal of PNE lead in the office


Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05799313


Related Trials