NCT05308017

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 1, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

March 6, 2022

Last Update Submit

March 19, 2024

Conditions

Benign Prostatic Hypertrophy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Surgeon evaluation of Laser scopes flow rate

    Day 0

  • Surgeon evaluation of Laser scope visualization

    Day 0

  • Surgeon evaluation of Laser scope bladder injury

    Day 0

Study Arms (2)

Richard Wolf 24F Laser scope

ACTIVE COMPARATOR
Device: Richard Wolf 24F Laser scope

Karl Storz 28F Laser scope

ACTIVE COMPARATOR
Device: Karl Storz 28F Laser Scope

Interventions

Richard Wolf 24F Laser scopeDEVICE

24F Laser with HoLEP

Richard Wolf 24F Laser scope
Karl Storz 28F Laser ScopeDEVICE

28 F Laser with HoLEP

Karl Storz 28F Laser scope

Eligibility Criteria

Age18 Years - 89 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale only
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who lack decisional capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Dean NS, Lee MS, Assmus MA, Guo J, Xu P, McDonald A, Fadl-Alla A, Helin J, Krambeck AE. Does Resectoscope Sheath Size Influence Holmium Laser Enucleation of the Prostate Outcomes? A Prospective Randomized Controlled Trial. J Endourol. 2023 Dec;37(12):1261-1269. doi: 10.1089/end.2023.0383.

    PMID: 37786336DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized to one of two different types of scopes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Endourology/Stone Division

Study Record Dates

First Submitted

March 6, 2022

First Posted

April 1, 2022

Study Start

May 1, 2022

Primary Completion

September 29, 2023

Study Completion

September 29, 2023

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)