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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-7 days
Awards & highlights

STIM Trial 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.Check my eligibility
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.See study design
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.

STIM Trial 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.

STIM Trial 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

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

STIM 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
1,030 Previous Clinical Trials
1,365,528 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the current trial accept enrollees?

"This medical study, originally posted on April 15th 2023 and most recently updated March 23rd 2023 is not accepting patients at this time. However, there are 73 other clinical trials actively recruiting research subjects."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead
2023. "Home Versus Office Removal of Percutaneous Nerve Evaluation (PNE) Lead". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05799313.
All > Overactive Bladder
~20 spots leftby Dec 2025
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