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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05308017
Enrollment
152
Registered
2022-04-01
Start date
2022-05-01
Completion date
2023-09-29
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hypertrophy

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).

Interventions

DEVICERichard Wolf 24F Laser scope

24F Laser with HoLEP

DEVICEKarl Storz 28F Laser Scope

28 F Laser with HoLEP

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

randomized to one of two different types of scopes.

Eligibility

Sex/Gender
MALE
Age
18 Years to 89 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Surgery Time difference between the 24F laser scope and the 28F laser scopeDay 0comparing operative time between the 24F and the 28F laser scope groups.

Secondary

MeasureTime frameDescription
Surgeon evaluation of Laser scopes flow rateDay 0Internal 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
Surgeon evaluation of Laser scope visualizationDay 0Internal 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 injuryDay 0Internal 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026