Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

December 4, 2024 updated by: Marcelino Rivera

28Fr Versus 22Fr HoLEP, a Randomized Controlled Trial Indiana University School of Medicine, Department of Urology

The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Physicians Urology

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:• Age >18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal

Exclusion Criteria:

  • Age < 18 years old
  • Existing stress or urge urinary incontinence
  • Planned overnight admission or overnight catheterization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HoLEP surgery with 22Fr
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
Device: 22 French sized rigid sheath
The 22Fr is the smaller, investigational sheath size to be used in this study.
Other Names:
  • 22Fr
Experimental: HoLEP surgery with 28Fr
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
Device: 28 French sized rigid sheath
The 28Fr is the standard of care sheath size used at this site.
Other Names:
  • 28Fr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Time Frame: M-ISI survey completed at 1,4,12 weeks
Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey.
M-ISI survey completed at 1,4,12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcelino Rivera

Collaborators

Indiana University

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 Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndianaU 14563

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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