NCT07565961 HoLEP-ThuLEP - Comparing Lasers for BPH Surgery
| NCT ID | NCT07565961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ludwig-Maximilians - University of Munich |
| Condition | BPH (Benign Prostatic Hyperplasia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-06-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Benign prostatic hyperplasia (BPH) is a very common condition in older men. As the prostate enlarges, it can press on the urethra and make urination difficult. Typical symptoms include a weak urinary stream, frequent urination, getting up at night to urinate, and a feeling that the bladder is not fully empty. When medication is no longer sufficient, surgical removal of the inner part of the prostate ("enucleation") is the recommended treatment. Two modern laser techniques are used for this operation. Holmium Laser Enucleation of the Prostate (HoLEP) is currently considered the reference standard, with very good long-term results and a low rate of re-operations. Thulium Laser Enucleation of the Prostate (ThuLEP) using a pulsed thulium laser is a newer alternative. Because the laser energy is delivered in short pulses, ThuLEP may allow more precise tissue cutting and better control of bleeding during surgery. So far, only limited high-quality randomized data directly compare the two techniques, particularly for patient-reported outcomes such as urinary symptoms, continence, and erectile function. Purpose of the study The HoT-Trial investigates whether ThuLEP is as effective as HoLEP for men who need surgery for an enlarged prostate, and whether there are differences in recovery, complication rates, urinary symptoms, continence, and erectile function after surgery. Research question Does ThuLEP lead to a similar improvement in lower urinary tract symptoms (LUTS) as HoLEP 12 months after surgery, measured by the change in the International Prostate Symptom Score (IPSS)? How the study works A total of 150 men aged 18 years or older with clinically relevant BPH, an IPSS of 8 or higher, a prostate volume above 40 ml, and an indication for surgery will take part. Each participant will be randomly assigned (1:1) to either ThuLEP or HoLEP. Participants are blinded to the assigned technique (single-blind design). Both procedures are established, guideline-recommended treatments; taking part in the study does not add any risks beyond standard care. Before surgery, participants complete standardized questionnaires (IPSS, ICIQ-SF, IIEF) and undergo uroflowmetry and residual urine measurement. Surgery is performed according to randomization. Participants are then followed up in the urology outpatient clinic at discharge and at 3, 6, and 12 months after surgery. The same measurements and questionnaires are repeated at each visit. Primary outcome Change in IPSS from baseline to 12 months after surgery. Secondary outcomes Maximum urinary flow rate (Qmax) and post-void residual urine; continence (ICIQ-SF) and erectile function (IIEF); operative time, laser time, blood loss, transfusion rate; catheter indwelling time and length of hospital stay; peri- and postoperative complications graded by the Clavien-Dindo classification; and the rate of re-intervention or re-catheterization within 12 months. Setting and timeline The study is conducted as a single-center trial at the Department of Urology, Ludwig-Maximilians-University Munich, Germany. Recruitment runs for approximately two years, with up to 12 months of follow-up per participant. The total study period is planned from April 2026 to April 2029. By directly comparing the two laser enucleation techniques in a randomized setting, the HoT-Trial aims to help patients and physicians choose the most suitable surgical treatment for benign prostatic hyperplasia.
Eligibility 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
Contact & Investigator
Yannic Volz, PD Dr. med.
STUDY CHAIR
LMU University Hospital
Frequently Asked Questions
Who can join the NCT07565961 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying BPH (Benign Prostatic Hyperplasia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07565961 currently recruiting?
Yes, NCT07565961 is actively recruiting participants. Contact the research team at yannic.volz@med.uni-muenchen.de for enrollment information.
Where is the NCT07565961 trial being conducted?
This trial is being conducted at Munich, Germany.
Who is sponsoring the NCT07565961 clinical trial?
NCT07565961 is sponsored by Ludwig-Maximilians - University of Munich. The principal investigator is Yannic Volz, PD Dr. med. at LMU University Hospital. The trial plans to enroll 150 participants.