Clinical trial Recruiting at 5 sites Interventional Men only

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.

More Prostate Hyperplasia trials

Quick facts

Study typeInterventional
SexMen only
Enrollment130 (estimated)
SponsorFundacio Puigvert
Academic / other
Drugs / interventionsradiation
Locations6 sites (Santiago de Compostela, A Coruña and 5 other locations)
StatusRecruiting
StartedApril 1, 2025
Main results expectedNovember 2030
Study endsNovember 2030
Registry record updatedApril 29, 2026
Trial IDNCT06649357 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  • Comparing two laser techniques for prostate surgery

    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.

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    This study is testing whether robotic surgery or laser surgery is better for treating men with prostate enlargement who haven't found relief from other treatments.

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  • Comparing two treatments for benign prostatic hyperplasia

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.