Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-80
SponsorAnkara University

About this trial

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH.

The purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation.

The primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence.

All laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes

Eligibility criteria

Qualifiers

Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for anatomical prostate enucleation

Presence of a prostate and clinical indication for surgical treatment

Age between 50 and 80 years

Disqualifiers

History or suspicion of prostate cancer

Previous prostate surgery

Presence of neurogenic bladder or significant lower urinary tract dysfunction unrelated to BPH

Active urinary tract infection at the time of surgery

Trial design

Treatments tested in this trial

  • Holmium:YAG Laser Prostate Enucleation
  • Thulium:YAG Laser Prostate Enucleation
  • Thulium Fiber Laser Prostate Enucleation

Treatment groups

159 Participants
are divided into 3 treatment groups

Sponsors and collaborators