Study on Safety and Use of a Single Device for Bipolar and Laser Prostate Surgery in Men with Enlarged Prostate

What this Trial Is About

This research aims to evaluate the feasibility and safety of using a single working element device compatible with both bipolar and laser enucleation techniques in prostate surgery for patients with benign prostatic hyperplasia BPH. The study will focus on real-time assessment of this new device to ensure its safe and effective integration before larger clinical trials are conducted. The investigation is led by Menoufia University and targets males aged 50 years and older with prostate enlargement requiring surgery. Participants will be divided into two groups one using bipolar enucleation where bipolar energy is applied for cutting and coagulation, and the other using laser enucleation with either Thulium or Holmium lasers for tissue dissection and hemostasis. Both groups will use the same single working element device designed to work with both energy types. This prospective study will observe the operative time and safety over a one-month period. During the study, participants will undergo surgical procedures with the assigned enucleation technique using the single device. Researchers will monitor operative time, safety outcomes, and effectiveness at one month post-procedure. They will also analyze costs associated with the operative time. The total participation involves preoperative assessment, the surgery itself, and follow-up evaluations to measure the devices performance and patient safety.

Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study