Bipolar TURP versus MOSES‑assisted Holmium laser enucleation for enlarged prostate
Official title: Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study
Run by Fundacio Puigvert · NCT06649357 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Sex | Men only |
| Enrollment | 130 (estimated) |
| Sponsor | Fundacio Puigvert Academic / other |
| Drugs / interventions | radiation |
| Locations | 6 sites (Santiago de Compostela, A Coruña and 5 other locations) |
| Status | Recruiting |
| Started | April 1, 2025 |
| Main results expected | November 2030 |
| Study ends | November 2030 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT06649357 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain Recruiting -
Fundacio Puigvert
Barcelona, Barcelona, Spain 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 -
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain Not yet recruiting
Study contacts
- Principal investigator: Ivan Schwartzmann Jochamowitz, MD — Fundacio Puigvert
- Study coordinator: Ivan Schwartzmann Jochamowitz, MD
- Email: ischwartzm@fundacio-puigvert.es
- Phone: 0034934169700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.