An observational study in Prostate and BPH (Benign Prostatic Hyperplasia), sponsored by Menoufia University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Menoufia University · Observational
A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.
the study will include male patients aged ≥50 years who are diagnosed with benign prostatic hyperplasia (BPH) , prostate volume ≥40 cc without 4prior history of prostate cancer while patients with ongoing urinary tract infections, prior prostate surgeries, coagulopathy or urethral strictures were excluded.
Exclusion Criteria:
Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation.
Device: A single working element for bipolar enucleation
Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Device: A single working element for laser enucleation
Device: A single working element compatible with both bipolar and laser modalities. The bipolar energy will be used for cutting and coagulation during enucleation.
Device: A single working element compatible with both bipolar and laser modalities. Thulium or Holmium laser will be employed for tissue dissection and hemostasis.
Feasibility
Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.
Time frame: the operative time
Safety
intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).
Time frame: 1 month
Efficacy
Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).
Time frame: 1 month
Cost Analysis
Cost of using a single working element vs. standard separate tools for bipolar and laser.
Time frame: the operative time
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Menoufia University