Comparing two laser treatments for enlarged prostate management

GreenLight (532nm) LASER (XPS) Enucleation vs. Thulium LASER Enucleation of Prostate for Treatment of Benign Prostatic Hyperplasia

This study is testing which of two laser treatments for enlarged prostates helps relieve urinary problems better for men with BPH.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 40 Years to 80 Years
• Sex: Male
• Sponsor: Mansoura University (Academic / other)
• Locations: 1 site (Al Mansurah, Dakahlia Governorate)
• Trial ID: NCT03305861 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of Greenlight Laser Enucleation of the Prostate (Green LEP) and Thulium Laser Enucleation of the Prostate (ThuLEP) in reducing lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). The study will involve a randomized controlled trial design, where patients will receive one of the two laser treatments. Researchers will evaluate various outcomes, including urinary flow parameters, prostate size changes, and any complications associated with the procedures. The trial seeks to provide insights into which laser technique offers better results for patients with significantly enlarged prostates.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 40 and older with lower urinary tract symptoms due to benign prostatic hyperplasia who have not responded to medical treatment.

Not a fit: Patients with neurological disorders affecting bladder function, active urinary tract infections, or known prostate cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from urinary obstruction due to enlarged prostates.

How similar studies have performed: Previous studies have shown promising long-term outcomes for Thulium laser techniques, indicating potential success for this comparative approach.

Eligibility criteria

Inclusion Criteria:

* Patients' age ≥ 40 years
* LUTS secondary to BOO due to BPH who failed medical treatment
* International prostate symptom scores (IPSS) \>15 and bother score (QOL) ≥ 3 (according to IPSS question 8)
* Peak urinary flow rate (Qmax) \<15 ml/sec with at least 125 ml voided volume or Patients with acute urine retention secondary to BPH who failed trial of voiding on medical treatment.
* ASA (American society of anaesthesiologists) score ≤3.
* TRUS prostate size \> /= 80 ml

Exclusion Criteria:

* Patient with neurological disorder which might affect bladder function as cerebrovascular stroke, Parkinson disease
* Active urinary tract infection,
* Presence of active bladder cancer (within the last 2 years)
* Known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and TRUS imaging followed by prostate biopsies if necessary.
* Patient has a disorder of the coagulation cascade (e.g., liver cell failure) or disorders that affect platelet count or function (e.g., von Willebrand disease) that would put the subject at risk for intraoperative or postoperative bleeding.
* Patient is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d) except for low-dose aspirin (e.g., 100 mg).
* Patient has had an acute myocardial infarction or open-heart surgery \<180 days prior to the date of informed consent.

Where this trial is running

Al Mansurah, Dakahlia Governorate

• Urology and Nephrology Center — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)

Study contacts

• Study coordinator: Mahmoud Nabil Laymon, MD

Conditions Prostatic Hyperplasia With Urinary Obstruction; Thulium Laser Enucleation of the Prostate; Greenlight Laser Enucleation of the Prostate