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โ† Trials
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EEAP Using Moses 2.0 Technology vs the Thulium Fiber Laser in Medium-Large Prostates

RecruitingNAAges 40 Years - 90 YearsMaleFundacio Puigvert
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In plain words

What the trial is, and whether it could suit you

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 MoL

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • MoLEP
  • ThuFLEP
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Where

3 sites
Fundacio Puigvert
Barcelona, Spain
Clinic Hospital of Barcelona
Barcelona, Spain
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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