Clinical trial NCT07014969: En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate
Official title: En-bloc Versus Lobe-by-lobe Holmium Laser Enucleation of the Prostate (HoLEP): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostate Hyperplasia
Bladder Outlet Obstruction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 123
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Benign prostatic hyperplasia (BPH) is one of the most commonly diagnosed conditions of the male genitourinary tract worldwide, resulting in approximately 1.2 million surgical procedures per year. Holmium laser enucleation of the prostate (HoLEP) has proven to be an efficient, durable, and safe surgical option for the management of BPH. The European Association of Urology (EAU) Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms (LUTS) in 2016 considered HoLEP (referred to as endoscopic enucleation of the prostate, EEP) as a reference technique for the management of large prostates.

The evolution of laser technology has revived the concept of anatomical enucleation, allowing the resectoscope to be used to dissect the adenoma from the surgical capsule, mimicking the surgeon's index finger in open prostatectomy. This concept of laser-assisted anatomical enucleation can be efficiently replicated by other types of laser energy apart from Holmium.

HoLEP was first described in 1998 as a three-lobe technique, involving the creation of two incisions at the bladder neck, then joining these incisions in front of the verumontanum before enucleating the median, left, and right lobes sequentially but its dissemination has been limited by a steep learning curve and relative procedural difficulty, especially in large glands as well as high rate of trasnient stress urinary incontinence.

More recently, 'en bloc' techniques have been introduced, which may offer advantages such as better visualization, faster identification of the surgical capsule and dissection plane, early release and better preservation of the sphincter, and an improved learning curve compared to the three-lobe technique.

One such en-bloc method involves identifying the correct plane between adenoma and capsule at the apex of the left lobe lateral to the verumontanum, extending the incision retrogradely towards the bladder, and using the endoscope to gently raise the lobe from the capsular plane, gradually exposing the dissection plane and reducing intraoperative difficulties such as bleeding and capsule perforation, while shortening enucleation time.

Feasibility studies of en-bloc HoLEP on patients with moderately enlarged prostates showed promising operative times and significant reductions in prostate-specific antigen (PSA) and transition zone volume, indicating effective adenoma removal.

Comparative studies between en-bloc HoLEP and traditional two- or three-lobe techniques have reported shorter enucleation times and lower laser energy use with the en-bloc approach.

Large randomized trials have similarly found that en-bloc HoLEP is associated with significantly shorter operative and enucleation times compared to the three-lobe technique.

Aim of the work

Growing evidence suggests that en-bloc enucleation of the prostatic adenoma, which involves dissection of the adenoma as a single tissue mass, offers advantages over the usual two- or three-lobe techniques: shortened operation time, optimal visualization of the dissection plane due to reduced bleeding and excellent irrigation, and improved enucleation effectiveness.

Early demarcation of the 'white line' leading to early release of the sphincter from the prostatic apex could reduce the likelihood of transient postoperative stress urinary incontinence. This is because the sphincter is less likely to be stretched during dissection movements, which can otherwise occur when the external sphincter is fixed on one side and the scope is dissecting on the opposite side.

In this study, the investigators aim to provide high-level evidence on the feasibility and efficacy of en-bloc enucleation using holmium lasers and its impact on early continence recovery. The investigators will conduct a well-designed randomized controlled trial comparing en-bloc endoscopic laser enucleation versus the conventional two- or three-lobe technique.

Eligibility criteria: 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 outcomes:
measure: Enucleation efficiency
timeFrame: perioperative/ periprocedural
measure: enucleation speed
timeFrame: perioperative/ periprocedural
Secondary outcomes:
measure: Resected prostate weight
timeFrame: perioperative/ periprocedural
measure: Incidence of early urinary incontinence
timeFrame: 1,3 and 6 months
measure: morcellation efficiency
timeFrame: perioperative/ periprocedural
measure: length of hospital stay
timeFrame: perioperative/ periprocedural
measure: total laser energy
timeFrame: perioperative/ periprocedural
measure: LASER/Prostate ratio
timeFrame: perioperative/ periprocedural
measure: volume of intraoperative irrigation
timeFrame: perioperative/ periprocedural
measure: perioperative blood loss
timeFrame: perioperative/ periprocedural
measure: catheterization time
timeFrame: perioperative/ periprocedural
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Urology and nephrology center
state: Outside U.S./Canada
Study officials:
affiliation: Mansoura Univeristy
name: Ahmed El-Assmy
role: STUDY_DIRECTOR
References: