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Search / Trial NCT06649357

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate

Launched by FUNDACIO PUIGVERT · Oct 17, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Prostate Hyperplasia Surgery Endoscopic Anatomical Enucleation Of The Prostate (Eeap)

ClinConnect Summary

This clinical trial is studying two different surgical methods for treating benign prostatic hyperplasia (BPH), a common condition that causes urinary problems in men. The two methods being compared are the Bipolar Transurethral Resection of the Prostate (Bi-TURP) and the Moses Assisted Holmium Laser Enucleation of the Prostate (MoLEP). The main goal is to see which procedure results in shorter hospital stays and better overall outcomes for patients. Researchers will also look at how long each surgery takes and the rate of any complications after the surgery.

To be eligible for this trial, participants must be men experiencing moderate to severe urinary symptoms and have a specific flow rate of urine. They should also have a prostate size between 40 and 80 cc. However, individuals who have had previous prostate surgeries, certain types of cancer, or specific bladder issues will not be included. Those who participate will be randomly assigned to receive either the MoLEP or Bi-TURP treatment, and their care will follow established medical practices at the participating hospitals. This study aims to provide clearer insights into the best surgical options for managing BPH.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Patients with maximum flow rate \< 15 ml/sec before obstructive surgery or with maximum flow rate \> 15 ml/sec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index \> 40.
  • Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35.
  • Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.
  • Exclusion Criteria:
  • History of prior prostatic obstructive or urethral surgery.
  • Diagnosis of prostate neoplasia.
  • Diagnosis of urothelial neoplasia.
  • Lack of flowmetry or IPSS data before surgery.
  • Diagnosis or suspicion of hypo/acontractile detrusor before prostatic obstructive surgery.
  • Diagnosis or suspicion of neurogenic bladder or neurological disease.
  • History of pelvic radiation therapy.

About Fundacio Puigvert

Fundació Puigvert is a leading non-profit organization dedicated to advancing medical research and clinical care in urology, nephrology, and andrology. Based in Barcelona, Spain, the foundation is committed to improving patient outcomes through innovative clinical trials and studies that seek to enhance understanding and treatment of urological and renal diseases. With a multidisciplinary team of experts, Fundació Puigvert fosters collaboration between researchers, clinicians, and healthcare professionals, ensuring that cutting-edge research translates into effective therapeutic strategies. The foundation is recognized for its ethical approach and dedication to patient-centered care, contributing significantly to the global medical community's knowledge and practices in these specialized fields.

Locations

Santiago De Compostela, A Coruña, Spain

Valladolid, , Spain

Barcelona, , Spain

Santiago De Compostela, , Spain

Gijón, Asturias, Spain

Hospitalet De Llobregat, Barcelona, Spain

Santander, Cantabria, Spain

Valladolid, , Spain

Patients applied

0 patients applied

Trial Officials

Ivan Schwartzmann Jochamowitz, MD

Principal Investigator

Fundacio Puigvert

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported