HoLEP vs BipolEP in Management of BPH Patients With Large Prostates

NCT06759194 · tracked via the Priya Life Science Egypt tracker

Sponsor

Assiut University

Phase

Not applicable

Started

2025-01-01

Last updated

2025-07-24

Condition(s) studied

Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

Holmium Laser Enucleation of the ProstateBipolar Enucleation of the Prostate

Holmium Laser Enucleation of the Prostate: Enucleation of the prostate gland using holmium laser energy

Bipolar Enucleation of the Prostate: Enucleation of the prostate gland using bipolar energy

Study summary

This is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

Eligibility

Sex

MALE

Min age

50 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age \>50 years * Prostate volume \>80 ml * Failure of or noncompliance with medical treatment * IPSS \>15 * Qmax \<15 ml/sec * Urinary retention and fixed catheters with poor results on trial of voiding without catheter Exclusion Criteria: * Patients with active UTI * Prostate cancer * Bladder carcinoma * Urethral stricture * Neurogenic bladder disorders * Redo cases

Primary outcome measure(s)

Change in peak flow rate — At 6 months after the procedure (HoLEP or BipolEP)
Treatment efficacy will be evaluated by comparing the change in peak flow rate (Qmax) on uroflowmetry between the two groups

Trial sites (1)

Facility	City	Region	Status
Assiut University Urology Hospital	Asyut	Egypt	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759194 on ClinicalTrials.gov ↗ ← All trials in Egypt