Urinary Incontinence
Conditions
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.
Interventions
PROCEDUREHoLEP Surgery
HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.
DEVICE28 French sized rigid sheath
The 28Fr is the standard of care sheath size used at this site.
DEVICE22 French sized rigid sheath
The 22Fr is the smaller, investigational sheath size to be used in this study.
Sponsors
Indiana University
Marcelino Rivera
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. | M-ISI survey completed at 1,4,12 weeks | Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey. |
Countries
United States
Outcome results
None listed