Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

Marcelino Rivera

Status: Withdrawn

Conditions: Urinary Incontinence

Treatments: Procedure: HoLEP Surgery; Device: 22 French sized rigid sheath; Device: 28 French sized rigid sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT06068790

IndianaU 14563

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

HoLEP surgery with 22Fr

Active Comparator group

Description:

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

Treatment:

Device: 22 French sized rigid sheath

HoLEP surgery with 28Fr

Experimental group

Description:

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

Treatment:

Device: 28 French sized rigid sheath