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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
Must not have
Age < 18 years old
Planned overnight admission or overnight catheterization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up m-isi survey completed at 1,4,12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am scheduled for an overnight hospital stay or catheterization.
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I experience sudden urges to urinate or leak urine.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Awards & Highlights

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

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.

Find a Location

Who is running the clinical trial?

Indiana UniversityOTHER
1,035 Previous Clinical Trials
1,218,853 Total Patients Enrolled
2 Trials studying Urinary Incontinence
180 Patients Enrolled for Urinary Incontinence
Marcelino RiveraLead Sponsor
~7 spots leftby Jan 2025
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