Comparing two laser techniques for prostate surgery

Prospective and Randomized Analysis of Endoscopic Prostate Enucleation Using Moses 2.0 Technology Versus the New Thulium Fiber Laser in Medium and Large Prostates.

This study is testing which of two laser surgery techniques works better for men with medium to large prostates who need help with urinary problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 90 Years
• Sex: Male
• Sponsor: Fundacio Puigvert (other)
• Locations: 3 sites (Barcelona, BARCELONA and 2 other locations)
• Trial ID: NCT06565741 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of two laser techniques, MoLEP and ThuFLEP, for endoscopic anatomical enucleation of the prostate in men with medium to large prostates. The study will evaluate the enucleation efficiency and perioperative bleeding associated with each technique. A total of 120 male patients aged 40 to 90 years, who are candidates for surgery due to lower urinary tract symptoms, will be randomly assigned to one of the two treatment groups. Follow-up assessments will occur at various intervals post-surgery to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are males aged 40 to 90 years with medium to large prostates and significant lower urinary tract symptoms.

Not a fit: Patients with a history of urethral stenosis or previous prostate surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recovery times for patients undergoing prostate surgery.

How similar studies have performed: Previous studies have shown promising results with both laser techniques, but this specific comparison is novel.

Eligibility criteria

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.

Where this trial is running

Barcelona, BARCELONA and 2 other locations

• 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)

Study contacts

• Principal investigator: Ivan Schwartzmann Jochamowitz, MD — Fundacio Puigvert
• Study coordinator: Ivan Schwartzmann Jochamowitz, MD

Conditions: Prostatic Hyperplasia, Surgery, Endoscopic Anatomical Enucleation of the Prostate, Medium and Large Prostates, Endoscopic Prostate Enucleation, Endoscopic anatomical enucleation of the prostate, Holmium laser, Thulium Fiber laser