Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath
Primary Purpose
Urinary Incontinence
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HoLEP Surgery
Sponsored by
About this trial
This is an interventional health services research trial for Urinary Incontinence
Eligibility 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
Sites / Locations
- Indiana University Health Physicians Urology
- Indiana University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
HoLEP surgery
Arm Description
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06068790
First Posted
August 29, 2023
Last Updated
September 28, 2023
Sponsor
Marcelino Rivera
Collaborators
Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT06068790
Brief Title
Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath
Official Title
28Fr Versus 22Fr HoLEP, A Randomized Controlled Trial Indiana University School of Medicine, Department of Urology
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcelino Rivera
Collaborators
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking 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
Allocation
N/A
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HoLEP surgery
Arm Type
Other
Arm Description
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
Intervention Type
Procedure
Intervention Name(s)
HoLEP Surgery
Intervention Description
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
Primary Outcome Measure Information:
Title
Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Indiana University Health Physicians Urology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath
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