An interventional study of En-bloc HoLEP in Benign Prostate Hyperplasia and Bladder Outlet Obstruction, sponsored by Mansoura University. Active, not recruiting at 1 site in Egypt. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's enrollment of 123 is above the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
classic 2 or 3 lobe technique with early apical release
Procedure: En-bloc HoLEP
Removal of the whole adenoma in one piece using laser energy
Enucleation efficiency
resected prostate weight divided by enucleation time
Time frame: perioperative/ periprocedural
enucleation speed
time between insertion. of laser fiber till complete detachment of the adenoma
Time frame: perioperative/ periprocedural
Resected prostate weight
Weight of resected prostatic tissue expressed in Grams
Time frame: perioperative/ periprocedural
Incidence of early urinary incontinence
assessment of incidence of early urge and stress urinary incontinence.
Time frame: 1,3 and 6 months
morcellation efficiency
Weight of resected prostate tissue in grams morcellated per minute expressed in (grams per minute)
Time frame: perioperative/ periprocedural
length of hospital stay
lenght of hospital admission measure in days
Time frame: perioperative/ periprocedural
total laser energy
Total Laser energy required expressed in Joules
Time frame: perioperative/ periprocedural
LASER/Prostate ratio
Laser energy required to resect one gram of prostatic tissue expressed in (kiloJoule per gram)
Time frame: perioperative/ periprocedural
volume of intraoperative irrigation
volume of irrigation saline volume expressed in Litres
Time frame: perioperative/ periprocedural
perioperative blood loss
haemoglobin deficit measured by the difference between preopeartive and postoperative hemoglobin expressed in Gm/dl
Time frame: perioperative/ periprocedural
catheterization time
time to catheter removal expressed in Days
Time frame: perioperative/ periprocedural
Plan to share: No
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Ran from Oct 2022 to primary completion in Oct 2024, 24 months.
Of 152 non-industry interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's 24 months is close to that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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