NCT06068790

Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Marcelino Rivera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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

• Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	HoLEP Surgery	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.
DEVICE	22 French sized rigid sheath	The 22Fr is the smaller, investigational sheath size to be used in this study.

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2023-10-05
• Last updated: 2024-12-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study