NCT05678452

Brief Summary

Holmium laser enucleation (HOLEP) has became a standard of treatment of large prostates that indicates surgery. HOLEP is widely used nowadays. Many settings are used but no optimal setting was world wide adopted. The aim of this trial is to assess the Low-power Holmium laser enucleation of the prostate (LP-HoLEP)and compare to high-power (HP-HoLEP) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

3.4 years

First QC Date

December 24, 2022

Last Update Submit

August 13, 2024

Conditions

Benign Prostatic Hyperplasia

Keywords

HOLEP, Enucleation, Prostate

Outcome Measures

Primary Outcomes (1)

  • Enucleation Efficiency

    Enucleated weight/min will be evaluated.

    3 hours

Secondary Outcomes (2)

  • Dysuria will be assessed by dysuria visual analog scale

    2 weeks

  • The complications of both techniques

    3 months

Study Arms (2)

LP-HoLEP

ACTIVE COMPARATOR

2J/25Hz setting

Procedure: HOLEP for treating BPH

HP-HoLEP.

ACTIVE COMPARATOR

2J/50Hz setting

Procedure: HOLEP for treating BPH

Interventions

HOLEP for treating BPHPROCEDURE

HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.

HP-HoLEP.LP-HoLEP

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • large prostate indicated for surgical intervention.

You may not qualify if:

  • prostate cancer
  • recurrent adenomas
  • associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - AlAzhar university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Mohamed F Salman, MD

CONTACT

+201111788996prof_mohamed_fawzy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 24, 2022

First Posted

January 10, 2023

Study Start

January 1, 2022

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

EG(1)