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

Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hypertrophy
• Intervention / Treatment: Device: Richard Wolf 24F Laser scope; Device: Karl Storz 28F Laser Scope

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Richard Wolf 24F Laser scope	Device: Richard Wolf 24F Laser scope; 24F Laser with HoLEP
Active Comparator: Karl Storz 28F Laser scope	Device: Karl Storz 28F Laser Scope; 28 F Laser with HoLEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hypertrophy
• Other Study ID Numbers: STU00215646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes