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Procedure

Sheath Size in HoLEP Surgery for Urinary Incontinence

N/A

Waitlist Available

Research Sponsored by Marcelino Rivera

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years old

Undergoing HoLEP for benign prostatic enlargement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up m-isi survey completed at 1,4,12 weeks

Awards & highlights

Study Summary

This trial looks at whether using smaller sheaths in prostate surgery can result in better outcomes.

Who is the study for?

This trial is for adults over 18 who are eligible for same-day catheter removal and undergoing HoLEP surgery due to benign prostatic enlargement. It's not suitable for those with existing stress or urge urinary incontinence, or if an overnight hospital stay or catheterization is planned.Check my eligibility

What is being tested?

The study aims to compare the outcomes of HoLEP surgery using two different instrument sizes: a smaller 22Fr sheath versus the standard larger 28Fr sheath, to see if there's any difference in patient recovery, specifically regarding urinary incontinence.See study design

What are the potential side effects?

Potential side effects from HoLEP surgery can include discomfort at the surgical site, bleeding, infection risk, temporary difficulty urinating, and possibly short-term changes in urinary control following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I am having surgery for an enlarged prostate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ m-isi survey completed at 1,4,12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~m-isi survey completed at 1,4,12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and m-isi survey completed at 1,4,12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HoLEP surgeryExperimental Treatment1 Intervention

HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityOTHER

983 Previous Clinical Trials

981,116 Total Patients Enrolled

2 Trials studying Urinary Incontinence

180 Patients Enrolled for Urinary Incontinence

Marcelino RiveraLead Sponsor

Frequently Asked Questions

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

Is this experiment still open to volunteers?

"The clinicaltrials.gov data suggests that this trial, which was initially published on August 1st 2023, is no longer searching for patients. However, there are still 146 other medical studies actively recruiting individuals at the present moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

Marcelino Rivera 2023. "Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06068790.

All > Urinary Incontinence