Comparative Study Between Safety and Effectiveness of High Versus Low Power HOLEP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HOLEP for treating BPH.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: from 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study Between Safety and Efficacy of High Versus Low Power HOLEP in Enucleation of the Prostate; Prospective Randomized Double Blind Trial
Overview
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
- Procedure HOLEP for treating BPH
HoLEP will be performed using 100W Versapulse, Luminis Inc., with 2J/25Hz for LP-HoLEP and 2J/50Hz for HP-HoLEP.
Primary outcome measures
- Enucleation Efficiency [Time frame: 3 hours]
Secondary outcome measures (2)
- Dysuria will be assessed by dysuria visual analog scale [Time frame: 2 weeks]
- The complications of both techniques [Time frame: 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Urology department - AlAzhar university — Cairo
Identifiers
NCT: NCT05678452 · low and high power HOLEP