Wolf 24 F vs. Storz 28 F Laser Sheath Size for HoLEP

Not Applicable

Completed

• Conditions: Benign Prostatic Hypertrophy
• Interventions: Device: Richard Wolf 24F Laser scope; Device: Karl Storz 28F Laser Scope

• Registration Number: NCT05308017
• Lead Sponsor: Northwestern University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-06
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-05-01
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 152

Inclusion Criteria

• Patients Males 18-89 undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms

Exclusion Criteria

• Patients who lack decisional capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Richard Wolf 24F Laser scope	Richard Wolf 24F Laser scope	-
Karl Storz 28F Laser scope	Karl Storz 28F Laser Scope	-

Primary Outcome Measures

Name	Time	Method
Surgery Time difference between the 24F laser scope and the 28F laser scope	Day 0	comparing operative time between the 24F and the 28F laser scope groups.

Secondary Outcome Measures

Name	Time	Method
Surgeon evaluation of Laser scope visualization	Day 0	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
Surgeon evaluation of Laser scope bladder injury	Day 0	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
Surgeon evaluation of Laser scopes flow rate	Day 0	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

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States