An interventional study of Tri-lobar HoLEP and En-bloc HoLEP in Benign Prostatic Hyperplasia With Outflow Obstruction, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
Several HoLEP techniques have been developed, with the conventional tri-lobar and the en-bloc approaches being the most commonly practiced. Although both techniques achieve comparable functional outcomes and safety profiles, they differ in surgical dissection strategy and anatomical orientation. Some authors suggest that the en-bloc technique may facilitate maintenance of the correct surgical plane, whereas others consider the tri-lobar approach easier for surgeons familiar with transurethral resection of the prostate (TURP). However, evidence comparing their learning characteristics remains limited.
Most published studies evaluating the HoLEP learning curve have investigated a single surgical technique or assessed a second technique after surgeons had already gained substantial HoLEP experience. Such study designs introduce significant bias because increasing surgical experience inevitably influences subsequent performance.
A prospective alternating design, in which a HoLEP-naïve surgeon performs consecutive tri-lobar and en-bloc procedures, may provide a more balanced comparison by exposing both techniques to similar levels of cumulative surgical experience while minimizing temporal bias.
Tanta University is the lead sponsor of 987 studies on the registry; 313 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Procedure: Tri-lobar HoLEP
Procedure: En-bloc HoLEP
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as 3 specimens (median lobe and 2 lateral lobes) using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
endoscopic, retro-grade dissection and liberation of the entire transition zone of the prostate (the hyperplastic adenoma) from the surrounding surgical capsule as a single, intact specimen using a holmium:yttrium-aluminum-garnet (Ho:YAG) laser
Number of cases required to achieve procedural proficiency
Number of cases required to achieve procedural proficiency, defined by a sustained plateau in enucleation efficiency (enucleated weight in gm/operative time in min) determined using RA-CUSUM. Risk-adjusted CUSUM adjusts for: * Prostate size * Operative time (Enucleation time + Morcellation time) * Enucleated weight
Time frame: 1 year
Enucleation time
Time frame: 1 year
Morcellation time
Time frame: 1 year
Enucleated weight
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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