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

NCT07014969 | Active Not Recruiting

• 1 other identifier: MS.21.07.1561
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Enucleation efficiency

  resected prostate weight divided by enucleation time

  perioperative/ periprocedural

• enucleation speed

  time between insertion. of laser fiber till complete detachment of the adenoma

  perioperative/ periprocedural

Secondary Outcomes (9)

• Resected prostate weight

  perioperative/ periprocedural

• Incidence of early urinary incontinence

  1,3 and 6 months

• morcellation efficiency

  perioperative/ periprocedural

• length of hospital stay

  perioperative/ periprocedural

• total laser energy

  perioperative/ periprocedural

Study Arms (2)

En-bloc HoLEP

EXPERIMENTAL

1. An inverted U-shaped incision in front of the veru montanum followed by extension of the incision laterally on both lateral lobes 2. Using the peak of the scope, blunt enucleation of the lateral lobes 3. Enucleation continued laterally with insinuation of the scope lateral to the enucleated lobe on both sides, ending by residual mucosal attachment of the adenoma to the sphincter between 11 and 1 O'clock positions 4. Release of the adenoma from the sphincter is done by transverse cutting of the mucosal attachment using 180 degree inverted scope the fiber position at 12 O'clock position of the scope 5. the enucleation process continued above the adenoma from side to side both bluntly and laser assisted till reaching the bladder neck 6. lateral dissection of the ad enoma will be carried out on both sides 7. Finally basal dissection of the adenoma and flipping of the both adenomas as one chunk to the bladder followed by laser cutting of any residual attachment.

Procedure: En-bloc HoLEP

Lobe by Lobe HoLEP

ACTIVE COMPARATOR

classic 2 or 3 lobe technique with early apical release

Procedure: En-bloc HoLEP

Interventions

En-bloc HoLEP PROCEDURE

Removal of the whole adenoma in one piece using laser energy

En-bloc HoLEP; Lobe by Lobe HoLEP

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients' age ≥ 40 years
• LUTS secondary to BOO due to BPH who failed medical treatment
• International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
• Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
• ASA (American society of anaesthesiologists) score ≤3.
• TRUS prostate size 80-200 ml

You may not qualify if:

• Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
• Active urinary tract infection,
• Presence of active bladder cancer.
• Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
• Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
• Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
• Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent. -

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases

Study Officials

• Ahmed El-Assmy

  Mansoura Univeristy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 11, 2025
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)