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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
The 28Fr is the standard of care sheath size used at this site.
The 22Fr is the smaller, investigational sheath size to be used in this study.
Indiana University Health Physicians Urology
Indianapolis, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
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.
Time frame: M-ISI survey completed at 1,4,12 weeks
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