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

Al-Azhar University

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia

Treatments: Procedure: HOLEP for treating BPH

Study type: Interventional

Funder types: Other

Identifiers

NCT05678452

low and high power HOLEP

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

LP-HoLEP

Active Comparator group

Description:

2J/25Hz setting

Treatment:

Procedure: HOLEP for treating BPH

HP-HoLEP.

Active Comparator group

Description:

2J/50Hz setting

Treatment:

Procedure: HOLEP for treating BPH