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Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP

Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05678452
Enrollment
200
Registered
2023-01-10
Start date
2022-01-01
Completion date
2025-09-01
Last updated
2024-08-15

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

Conditions

Benign Prostatic Hyperplasia

Keywords

HOLEP, Enucleation, Prostate

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.

Interventions

PROCEDUREHOLEP for treating BPH

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

double blind

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* large prostate indicated for surgical intervention.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Enucleation Efficiency3 hoursEnucleated weight/min will be evaluated.

Secondary

MeasureTime frameDescription
Dysuria will be assessed by dysuria visual analog scale2 weeksburning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale
The complications of both techniques3 monthsThe complications will be classified according to the modified Clavien classification system.

Countries

Egypt

Contacts

Primary ContactMohamed F Salman, MD
prof_mohamed_fawzy@yahoo.com+201111788996

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026