HoLEP-ThuLEP - Comparing Lasers for BPH Surgery (HOT)

Background and rationale Benign prostatic syndrome (BPS) is among the most frequent urological diseases in older men and a leading cause of treatment-requiring lower urinary tract symptoms (LUTS). For moderately to severely enlarged prostates, endoscopic enucleation procedures have become the surgical gold standard. Holmium Laser Enucleation of the Prostate (HoLEP) is considered the reference technique, with excellent long-term functional outcomes and a low re-intervention rate.

Thulium Laser Enucleation of the Prostate (ThuLEP) using pulsed thulium laser technology (wavelength approximately 2013 nm) has been introduced as an alternative enucleation procedure. The high absorption in water enables precise tissue dissection while allowing effective hemostasis, and the pulsed energy delivery may offer advantages in tissue control, precision, and intraoperative hemostasis. However, adequately powered prospective randomized trials directly comparing ThuLEP and HoLEP remain scarce, and patient-reported outcomes such as IPSS and ICIQ-SF are insufficiently studied.

Objectives The primary objective is to compare the improvement of LUTS between ThuLEP and HoLEP, measured as the change in IPSS from baseline to 12 months postoperatively. Secondary objectives include comparison of functional outcomes (Qmax, post-void residual urine), urinary continence (ICIQ-SF), erectile function (IIEF), perioperative parameters (operative time, laser time, blood loss, catheter indwelling time, length of hospital stay), complication rates (Clavien-Dindo), and re-intervention and re-catheterization rates.

Design Prospective, randomized, single-blind (participant-blinded), interventional comparative trial with 1:1 allocation to ThuLEP or HoLEP. Randomization is performed using sealed envelopes drawn preoperatively. Follow-up duration is 12 months per participant.

Study procedures After establishing the indication for surgical treatment of BPS, patients are screened and informed. Following written informed consent, patients are randomized. Baseline assessment (IPSS, Qmax, post-void residual urine, IIEF, ICIQ-SF) is performed the day before surgery. Surgery is performed according to randomization. Clinical baseline data (laboratory parameters, age, medications, comorbidities) and perioperative data (operative time, resection weight, laser energy) are extracted from operative and medical records. Postoperative assessments are performed at discharge and at 3, 6, and 12 months in the urology outpatient clinic, where patients are scheduled for follow-up visits.

Sample size Sample size calculation is based on the primary endpoint ΔIPSS. Assuming a clinically relevant difference of 5 IPSS points, a standard deviation of 7 points, a power of 80-90%, and a significance level of α = 0.05, approximately 64-86 patients per group are required. Allowing for a 10% drop-out rate, a total of 150 patients will be enrolled.

Risk-benefit Both surgical techniques are established, guideline-concordant treatments of BPS. Participation in the study does not introduce additional procedural risks. A potential benefit is the optimization of individualized treatment strategies for future patients.

Data management Data processing follows medical confidentiality and data protection regulations. Patient data are pseudonymized using an automatically generated code linked to name and date of birth; the decoding key is accessible only to the study team. Data are stored exclusively on secure computers within the hospital network and retained for a maximum of 10 years. No biological material is collected. No data transfer to third parties is planned. Participants may request deletion of their data at any time.