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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 150 (estimated) |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Status | Recruiting |
| Started | September 5, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT07565961 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
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Urologische Klinik und Poliklinik, LMU Klinikum
Munich, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Yannic Volz, PD Dr. med.
- Email: yannic.volz@med.uni-muenchen.de
- Phone: +498944000
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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.