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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Holmium:YAG Laser Prostate Enucleation
Procedure/SurgeryAnatomical prostate enucleation performed using a Holmium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
Thulium:YAG Laser Prostate Enucleation
Procedure/SurgeryAnatomical prostate enucleation performed using a Thulium:YAG laser system as part of standard surgical treatment for benign prostatic hyperplasia.
Thulium Fiber Laser Prostate Enucleation
Procedure/SurgeryAnatomical prostate enucleation performed using a Thulium Fiber Laser (TFL) system as part of standard surgical treatment for benign prostatic hyperplasia.
Treatment groups
Trial outcomes
Primary outcomes
Laser Enucleation Efficiency (g/J)
Laser enucleation efficiency will be evaluated by calculating the amount of enucleated prostate tissue in grams per joule of laser energy used (g/J), based on intraoperative laser system data and enucleated tissue weight recorded during surgery.
Secondary outcomes
Change in International Prostate Symptom Score (IPSS)
Change in the International Prostate Symptom Score (IPSS) from preoperative assessment to postoperative follow-up will be evaluated to assess functional outcomes after prostate enucleation.
Postoperative Urinary Incontinence
The presence of postoperative urinary incontinence will be assessed during routine postoperative follow-up visits.
Sponsors and contacts
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