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En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate

NCT07014969 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2025-06-11

No results posted yet for this study

Summary

Since its introduction in 1998 , and through numerous level 1a evidence, Holmium Laser enucleation of the prostate (HoLEP) has come to be considered a size-independent golden standard treatment for management of bladder outlet obstruction (BOO) secondary to benign prostatic hyperplasia (BPH) endorse by all guidelines.

Furthermore, Holep, together with minimaly invasive simple prostatectomy, is considered the most accepted alternative to Open simple protatectomy for prostates larger than 80ml.

Despite being the most thoroughly investigated laser technique with enduring efficacy and low morbidity, HoLEP remains restricted to relatively few centers mostly due to the long flat learning curve and lack of access to mentorship programs . On the other hand, the prevalence of stress urinary incontinence following HoLEP was reported to be about (3.3%-26% ) To overcome these difficulties hindering the wide-spread adoption of HoLEP, several modifications of the original three-lobe technique have been described to improve surgical outcomes and overcome the learning difficulties .

One of the newer modifications for AEEP that have shown promising results is the en-bloc enucleation with early apical release developed by Sancha et al in 2015 utilizing Green Light LASER which has the potential advantage of preserving the integrity of the external sphincter . The same principles of early apical liberation and sphincter mucosal preservation have been applied to lobe by lobe techniques as well.

In this work the investigators aim to obtain high level evidence of efficacy of En-bloc HoLEP and its impact on early recovery of continence in comparison to the conventional lobe-by-lobe (LBL) HoLEP.

Conditions

  • Benign Prostate Hyperplasia
  • Bladder Outlet Obstruction

Interventions

PROCEDURE

En-bloc HoLEP

Removal of the whole adenoma in one piece using laser energy

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Ahmed El-Assmy · Mansoura Univeristy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-10-01
Completion
2025-10-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014969 on ClinicalTrials.gov