Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Comparing holmium and thulium laser prostate enucleation for enlarged prostate

Official title: Prospective Randomized Comparative Study Evaluating Functional and Perioperative Outcomes After Thulium Laser Enucleation of the Prostate (ThuLEP) Versus Holmium Laser Enucleation of the Prostate (HoLEP)

Run by Ludwig-Maximilians - University of Munich · NCT07565961 · Data updated 2026-11-12

This compares two laser operations—HoLEP and ThuLEP—to see which gives better symptom relief for men with an enlarged prostate (BPH) who need surgery.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment150 (estimated)
SponsorLudwig-Maximilians - University of Munich
Academic / other
Locations1 site (Munich, Bavaria)
StatusRecruiting
StartedSeptember 5, 2026
Main results expectedDecember 30, 2026
Study endsDecember 31, 2027
Registry record updatedOctober 7, 2026
Trial IDNCT07565961 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18 or older with clinically significant BPH, IPSS ≥8, prostate volume >40 mL, and a surgical indication who can provide informed consent are the intended participants.

Probably not a fit

Patients with known or suspected prostate cancer, prior prostate or urethral surgery, neurogenic bladder dysfunction, or anticoagulation that cannot be paused are excluded and therefore not expected to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with bothersome BPH and prostate volume >40 mL who require surgical enucleation are randomized to receive either Holmium Laser Enucleation of the Prostate (HoLEP) or pulsed Thulium Laser Enucleation of the Prostate (ThuLEP) at LMU Klinikum. The primary outcome is change in International Prostate Symptom Score (IPSS) from baseline to 12 months, with secondary outcomes including urinary flow (Qmax), post-void residual, continence (ICIQ-SF), erectile function (IIEF), and perioperative metrics such as operative time, blood loss, and catheter time. Follow-up visits collect both objective measures and patient-reported outcomes to evaluate functional recovery and complications. The comparison aims to determine whether ThuLEP's pulsed thulium energy offers advantages in precision or hemostasis over the established HoLEP technique.

Why it matters

Potential benefit: If ThuLEP matches or improves on HoLEP, patients could receive similar or better symptom relief with potentially less bleeding or faster perioperative recovery.

How similar studies have gone: HoLEP is well established with strong long-term evidence, while ThuLEP is promising but comparative randomized data directly demonstrating superiority are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male, age ≥ 18 years
* Clinically relevant benign prostatic syndrome (BPS) with an established indication for surgical treatment
* International Prostate Symptom Score (IPSS) ≥ 8
* Prostate volume \> 40 ml
* Signed written informed consent

Exclusion Criteria:

* Proven or suspected prostate cancer
* Previous surgery of the prostate or urethra
* Neurogenic bladder dysfunction
* Anticoagulation therapy that cannot be paused perioperatively

Where it's running

  • Urologische Klinik und Poliklinik, LMU Klinikum
    Munich, Bavaria, Germany
    Recruiting

Study contacts

Similar studies

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

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.