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Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

NCT ID: NCT06068790

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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 Groups

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HoLEP surgery with 22Fr

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

Group Type ACTIVE_COMPARATOR

22 French sized rigid sheath

Intervention Type DEVICE

The 22Fr is the smaller, investigational sheath size to be used in this study.

HoLEP surgery with 28Fr

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

Group Type EXPERIMENTAL

28 French sized rigid sheath

Intervention Type DEVICE

The 28Fr is the standard of care sheath size used at this site.

Interventions

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HoLEP Surgery

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

Intervention Type PROCEDURE

28 French sized rigid sheath

The 28Fr is the standard of care sheath size used at this site.

Intervention Type DEVICE

22 French sized rigid sheath

The 22Fr is the smaller, investigational sheath size to be used in this study.

Intervention Type DEVICE

Other Intervention Names

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28Fr 22Fr

Eligibility Criteria

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Exclusion Criteria

* Age \< 18 years old
* Existing stress or urge urinary incontinence
* Planned overnight admission or overnight catheterization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role collaborator

Marcelino Rivera

OTHER

Sponsor Role lead

Responsible Party

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Marcelino Rivera

Assistant Professor of Urology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Indiana University Health Physicians Urology

Indianapolis, Indiana, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IndianaU 14563

Identifier Type: -

Identifier Source: org_study_id