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

NCT07014969 · tracked via the Priya Life Science Egypt tracker

Sponsor

Mansoura University

Phase

Not applicable

Started

2022-10-01

Last updated

2025-06-11

Condition(s) studied

Benign Prostate HyperplasiaBladder Outlet Obstruction

Investigational drug(s) / intervention(s)

En-bloc HoLEP

En-bloc HoLEP: Removal of the whole adenoma in one piece using laser energy

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.

Eligibility

Sex

MALE

Min age

40 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Patients' age ≥ 40 years 2. LUTS secondary to BOO due to BPH who failed medical treatment 3. International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8) 4. 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. 5. ASA (American society of anaesthesiologists) score ≤3. 6. TRUS prostate size 80-200 ml Exclusion Criteria: 1. Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease 2. Active urinary tract infection, 3. Presence of active bladder cancer. 4. 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. 5. 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. 6. Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg). 7. Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent. -

Primary outcome measure(s)

Enucleation efficiency — perioperative/ periprocedural
resected prostate weight divided by enucleation time
enucleation speed — perioperative/ periprocedural
time between insertion. of laser fiber till complete detachment of the adenoma

Trial sites (1)

Facility	City	Region	Status
Urology and nephrology center	Al Mansurah	Outside U.S./Canada

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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 NCT07014969 on ClinicalTrials.gov ↗ ← All trials in Egypt