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NCT06068790 Clinical Trial

Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

Urinary Incontinence Clinical Trial

Official title:
28Fr Versus 22Fr HoLEP, A Randomized Controlled Trial Indiana University School of Medicine, Department of Urology

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06068790
Other study ID # IndianaU 14563
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date July 1, 2025

Study information
Verified date September 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 126
Est. completion date July 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Indiana University Indianapolis Indiana
United States Indiana University Health Physicians Urology Indianapolis Indiana

Sponsors (2)
Lead Sponsor Collaborator
Marcelino Rivera Indiana University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. 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
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