En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate (NCT07014969) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
En-bloc With Early Apical Release Versus Lobe-by-lobe LASER Enucleation of the Prostate
Egypt123 participantsStarted 2022-10-01
Plain-language 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.
Who can participate
Age range
40 Years – 80 Years
Sex
MALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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. -