Condition: Prostatic Hyperplasia · Surgery · Endoscopic Anatomical Enucleation of the Prostate (EEAP) · Sponsor: Fundacio Puigvert
Introduction: Endoscopic anatomical enucleation of the prostate (EEAP) with lasers has emerged as an effective and less invasive surgical option compared to traditional methods. Among the various available laser options, Holmium laser and Thulium Fiber laser have stood out as two prominent approaches for performing endoscopic prostate enucleation. These technologies have 3 showcased their effectiveness in ablating prostatic tissue and improving urinary symptoms. Nevertheless, differences in their physical properties and modes of action may impact their success rates and clinical outcomes. In our institution it is standard practice to use one laser or the other according to their availability in the operating room. Primary Objective: To demonstrate the superiority of MoLEP over ThuFLEP in terms of enucleation efficiency. Secondary Objectives: a) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of perioperative bleeding. b) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of postoperative hospital stay. c) To demonstrate the non-inferiority of ThuFLEP compared to ThuFLEP in terms of perioperative complications. d) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in urinary symptoms. e) To demonstrate the non-inferiority of MoLEP compared to ThuFLEP in terms of improvement in flowmetric variables. Study Type: Prospective, randomized, non-blind, multicentric clinical trial. Intervention:…
This description comes directly from the study's public registry record.
Ivan Schwartzmann Jochamowitz, MD · 0034934169700 · ischwartzm@fundacio-puigvert.es
Silvia Mateu, MD · 0034934169700 · smateu@fundacio-puigvert.es
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| Fundacio Puigvert | Barcelona, BARCELONA, Spain | Recruiting |
| Clinic Hospital of Barcelona | Barcelona, BARCELONA, Spain | Recruiting |
| Hospital Univesitari de Bellvitge | L'Hospitalet de Llobregat, BARCELONA, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06565741