RecruitingNot Applicable

EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates

Spain120 participantsStarted 2024-09-03

Plain-language summary

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: Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or ThuFLEP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50 cases) and possessing experience with both laser types, will perform the surgical procedure.

Who can participate

Age range40 Years – 90 Years

SexMALE

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Inclusion Criteria: * Males aged between 40 and 90 years. * Patients who, due to their lower urinary tract symptoms, are candidates for BPH surgery, including: * Obstructive urinary symptoms evaluated through IPSS with a score \>7 and QoL \> 2 or acute urinary reten on refractory to catheter removal. * Obstructive urinary flow evaluated through uroflowmetry with Qmax\< 15 ml/s, obstruction demonstrated by pressure/flow study, prostatic origin haematuria refractory to medical treatment, or acute urinary retention refractory to catheter removal. * Prostatic volume measured by transabdominal ultrasound, transrectal ultrasound, or magnetic resonance imaging of more than 80 cc. * Prostate-specific antigen (PSA) \< 4 ng/ml, or with multiparametric prostate magnetic resonance imaging reporting PIRADS \< 3 or equal to 3 with PSA density \< 15%. Exclusion Criteria: * Diagnosis, suspicion, or history of urethral stenosis or urethral surgery. * History of prostate surgery or pelvic radiotherapy. * Diagnosis or suspicion of prostate cancer or urothelial cancer. * Body mass index superior to 30.

What they're measuring

SURGICAL TIME

Timeframe: Total time of Surgery procedure

Trial details

NCT IDNCT06565741

SponsorFundacio Puigvert

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Ivan Schwartzmann Jochamowitz, MD

0034934169700 ischwartzm@fundacio-puigvert.es