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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05308017
• Other study ID #: STU00215646
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Device:
• Richard Wolf 24F Laser scope
24F Laser with HoLEP
• Karl Storz 28F Laser Scope
28 F Laser with HoLEP

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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