RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-06-07
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05799313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years of age
  2. * Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome
  1. * Inability to comprehend written and/or spoken English
  2. * Inability to provide informed consent
  3. * Patients undergoing SNM for other indications (e.g. urinary retention, fecal incontinence,)
  4. * Previous SNM treatment
  5. * No home support to assist with lead removal

Contacts and Locations

Study Contact

Cecile A. Ferrando, M.D.
CONTACT
216-444-0642
ferranc2@ccf.org

Principal Investigator

Cecile A. Ferrando, M.D.
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Cecile A. Ferrando, M.D., PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-07
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-06-07
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Overactive Bladder