Benign Prostatic Hypertrophy Clinical Trial
Official title:
Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate
Verified date | March 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare two different types of scopes that can be used for HoLEP. HoLEP is performed through the urethra using a Laser scope to remove obstructing prostate tissue. Laser scopes come in different sizes (diameters).
Status | Completed |
Enrollment | 152 |
Est. completion date | September 29, 2023 |
Est. primary completion date | September 29, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms Exclusion Criteria: - Patients who lack decisional capacity |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgery Time difference between the 24F laser scope and the 28F laser scope | comparing operative time between the 24F and the 28F laser scope groups. | Day 0 | |
Secondary | Surgeon evaluation of Laser scopes flow rate | Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
1) How was the flow through the scope? a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good |
Day 0 | |
Secondary | Surgeon evaluation of Laser scope visualization | Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
2) How was the visualization? a. 1) Poor 2) Problematic 3) Mediocre 4) Adequate 5) Good |
Day 0 | |
Secondary | Surgeon evaluation of Laser scope bladder injury | Internal survey within REDCap to be completed by the surgeon using the scope. The survey will ask the surgeon the following questions after every surgery
3) Did bladder injury occur? a. 1) Yes 2) No |
Day 0 |
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