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NCT Number: NCT05678452

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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology department - AlAzhar university

Cairo, Egypt

Location status: Recruiting

Location contact

Mohamed F Salman, MD

CONTACT

[email protected]

+201111788996

Mohamed F Salman, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HOLEP for treating BPH

Procedure

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

Primary outcomes

  1. Enucleation Efficiency

    Time frame: 3 hours

    Enucleated weight/min will be evaluated.

Secondary outcomes

  1. Dysuria will be assessed by dysuria visual analog scale

    Time frame: 2 weeks

    burning micturation after the procedure. Dysuria will be assessed by dysuria visual analog scale

  2. The complications of both techniques

    Time frame: 3 months

    The complications will be classified according to the modified Clavien classification system.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed F Salman, MD

CONTACT

[email protected]

+201111788996

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 10, 2023
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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