No phaseRecruitingAge-related condition

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

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)

Sponsor
Ludwig-Maximilians - University of Munich (Academic or other)
Enrolment
150 planned
Conditions
BPH (Benign Prostatic Hyperplasia)
Interventions
Thulium Laser Enucleation of the Prostate (ThuLEP); Holmium Laser Enucleation of the Prostate (HoLEP)
Ages
adults, older adults
Registry
NCT07565961

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Change in International Prostate Symptom Score (IPSS) at 12 months

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered