Comparing holmium and thulium laser prostate enucleation for enlarged prostate
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (Munich, Bavaria) |
| Trial ID | NCT07565961 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: HoLEP is well established with strong long-term evidence, while ThuLEP is promising but comparative randomized data directly demonstrating superiority are limited.
Eligibility criteria
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 this trial is running
Munich, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.