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Search / Trial NCT05799313

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

Launched by THE CLEVELAND CLINIC · Mar 23, 2023

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how women feel about removing a device called a PNE lead, which is used to help treat overactive bladder. The study compares two ways to remove this lead: some women will take it out at home, while others will have it removed in a doctor's office. The researchers want to find out if there is a difference in satisfaction between these two methods.

To participate in this trial, women must be at least 18 years old and are planning to undergo a specific therapy for bladder issues. However, those who have had previous treatments, cannot understand English well, or do not have someone at home to help them with the lead removal won't be eligible. If you join the study, you can expect to share your experience and feelings about the lead removal process, whether done at home or in the office. This information will help improve care for women dealing with overactive bladder in the future.

Gender

FEMALE

Eligibility 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

About The Cleveland Clinic

The Cleveland Clinic is a renowned nonprofit academic medical center based in Cleveland, Ohio, recognized for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, the Cleveland Clinic leverages its multidisciplinary expertise and state-of-the-art facilities to conduct groundbreaking studies aimed at improving patient outcomes across a wide range of medical conditions. With a strong emphasis on patient-centered care, the institution fosters collaboration among researchers, clinicians, and patients to explore new treatments and therapies, contributing significantly to the global body of medical knowledge.

Locations

Cleveland, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Cecile A. Ferrando, M.D.

Principal Investigator

The Cleveland Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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