NCT06531473

Brief Summary

The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

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

Study Start

First participant enrolled

March 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

June 26, 2024

Last Update Submit

August 18, 2026

Conditions

Urologic DiseasesProstate Obstruction

Outcome Measures

Primary Outcomes (1)

  • Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.

    Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.

    2 years

Study Arms (3)

2J 40hz Laser Energy

EXPERIMENTAL

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz

Procedure: HoLEP

2J 50hz Laser Energy

EXPERIMENTAL

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz

Procedure: HoLEP

2J 60hz Laser Energy

EXPERIMENTAL

Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz

Procedure: HoLEP

Interventions

HoLEPPROCEDURE

Patients will be randomized to one of the laser energy groups day of surgery.

2J 40hz Laser Energy2J 50hz Laser Energy2J 60hz Laser Energy

Eligibility Criteria

Age18 Years - 89 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates

You may not qualify if:

  • Prostates measurements over 200g
  • Patients who lack decisional capacity
  • Patients who are non-english speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Amy Krambeck, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urologic Surgeon

Study Record Dates

First Submitted

June 26, 2024

First Posted

August 1, 2024

Study Start

March 4, 2024

Primary Completion

August 30, 2025

Study Completion

April 30, 2026

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)