← Back to Search

Home vs Office PNE Lead Removal for Overactive Bladder (STIM Trial)

N/A
Recruiting
Led By Cecile A. Ferrando, M.D.
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing sacral neuromodulation (SNM) for urinary urgency incontinence or urgency-frequency syndrome
Age greater than or equal to 18 years of age
Must not have
Previous SNM treatment
Patients undergoing SNM for other indications (e.g. urinary retention, fecal incontinence)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-7 days
Awards & highlights
No Placebo-Only Group

Summary

This trial assesses if women with overactive bladder benefit from having their PNE lead removed at home or in the office.

Who is the study for?
This trial is for women over 18 with overactive bladder who are undergoing a nerve evaluation called PNE as part of their treatment. They must understand English, be able to consent, and have someone at home to help if they choose home removal.
What is being tested?
The study aims to compare patient satisfaction between two methods of removing the PNE lead: doing it at home versus in a medical office after the initial therapy trial to see which method patients prefer.
What are the potential side effects?
While specific side effects aren't listed for this procedure, typical risks may include discomfort or pain where the lead was inserted and potential infection risk from improper removal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am receiving SNM therapy for sudden strong urges to urinate or frequent urination.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had sacral neuromodulation treatment before.
Select...
I am receiving SNM therapy for issues like urinary retention or fecal incontinence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient satisfaction between at home versus in office PNE lead removal
Secondary study objectives
Patient discomfort with PNE lead removal
Patient discomfort with PNE trial overall
Patient inconvenience for PNE lead removal
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: At home removalExperimental Treatment1 Intervention
Group II: In office removalActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,730 Total Patients Enrolled
Cecile A. Ferrando, M.D.Principal InvestigatorThe Cleveland Clinic

Media Library

At home removal Clinical Trial Eligibility Overview. Trial Name: NCT05799313 — N/A
Overactive Bladder Research Study Groups: At home removal, In office removal
Overactive Bladder Clinical Trial 2023: At home removal Highlights & Side Effects. Trial Name: NCT05799313 — N/A
At home removal 2023 Treatment Timeline for Medical Study. Trial Name: NCT05799313 — N/A
~11 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top