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

• Sponsor: Northwestern University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05308017
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hypertrophy	Device: Richard Wolf 24F Laser scope; Device: Karl Storz 28F Laser Scope	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized to one of two different types of scopes.randomized to one of two different types of scopes.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Does Sheath Size Matter? Wolf 24 F vs. Storz 28 F Laser Sheath Size for Holmium Laser Enucleation of the Prostate
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who lack decisional capacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amy Krambeck, Director of the Endourology/Stone Division, Northwestern University
• ClinicalTrials.gov Identifier: NCT05308017
• Other Study ID Numbers: STU00215646
• First Posted: Apr 1, 2022
• Last Update Posted: May 11, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hypertrophy

Study Results

No Results Posted as of May 11, 2022