Bipolar TURP versus MOSES‑assisted Holmium laser enucleation for enlarged prostate

Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study

This trial will test whether MOSES‑assisted Holmium laser enucleation (MoLEP) or bipolar transurethral resection (Bi‑TURP) leads to shorter hospital stays and improved intraoperative outcomes for men with symptomatic benign prostatic hyperplasia and prostate volumes of 40–80 cc.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sex: Male
• Sponsor: Fundacio Puigvert (other)
• Drugs / interventions: radiation
• Locations: 6 sites (Santiago de Compostela, A Coruña and 5 other locations)
• Trial ID: NCT06649357 on ClinicalTrials.gov

What this trial studies

This interventional trial compares two surgical approaches for BPH: MOSES‑augmented HoLEP using the Lumenis Pulse 120H with contemporary single‑use MOSES 2.0 fibers and modern morcellation versus bipolar transurethral resection of the prostate (Bi‑TURP). Men meeting symptom, flow, and prostate volume criteria (IPSS 8–35, flowmetry or urodynamic obstruction, prostate 40–80 cc) will undergo one of the procedures and have perioperative metrics recorded. Primary and secondary outcomes include hospital stay, transfusion and complication rates, operative time, and functional outcomes such as IPSS and maximum urinary flow. The trial focuses on current generation laser/morcellator technology to re‑evaluate differences previously reported with older equipment.

Who should consider this trial

Good fit: Ideal candidates are men with symptomatic BPH (IPSS 8–35), prostate volume between 40 and 80 cc, and obstructive flow on flowmetry or urodynamics (Qmax <15 ml/s or bladder outlet obstruction index >40).

Not a fit: Patients with prior prostatic or urethral surgery, prostate or urothelial cancer, suspected hypo/acontractile detrusor or neurogenic bladder, prior pelvic radiation, or missing baseline flow/IPSS data are excluded and unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the MoLEP approach could reduce bleeding and hospital stay and improve intraoperative efficiency while maintaining similar urinary function compared with Bi‑TURP.

How similar studies have performed: Previous studies have generally shown HoLEP reduces transfusion rates and hospital stay versus TURP while producing similar functional outcomes, but MOSES‑augmented HoLEP and newer morcellators are more recent innovations with more limited direct comparison data.

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.

Where this trial is running

Santiago de Compostela, A Coruña and 5 other locations

• Complejo Hospitalario Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain (RECRUITING)
• Fundacio Puigvert — Barcelona, BARCELONA, Spain (RECRUITING)
• Hospital Univesitari de Bellvitge — L'Hospitalet de Llobregat, BARCELONA, Spain (NOT_YET_RECRUITING)
• Hospital Universitario Marqués de Valdecillas — Santander, Cantabria, Spain (RECRUITING)
• Hospital Universitario de Cabueñes — Gijón, Principality of Asturias, Spain (RECRUITING)
• Hospital Universitario Río Hortega — Valladolid, Valladolid, Spain (RECRUITING)

Study contacts

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

Conditions: Prostate Hyperplasia, Surgery, Endoscopic Anatomical Enucleation of the Prostate, Prostate hyperplasia, Endoscopic anatomical enucleation of the prostate