RecruitingNCT07020364

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

Sponsor

Menoufia University

Enrollment

60 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Prostate BPH (Benign Prostatic Hyperplasia)

Summary

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.

Eligibility

Sex: MALEMin Age: 50 Years

Inclusion Criteria3

Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention.
Prostate volume ≥40 cc (as assessed by transrectal ultrasound).
No prior history of prostate cancer.

Exclusion Criteria4

Patients with ongoing urinary tract infections.
Prior prostate surgeries.
Coagulation disorders or patients on long-term anticoagulation therapy.
Known urethral strictures or other anatomical abnormalities complicating endoscopic procedures.

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Interventions

DEVICEA single working element for bipolar 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.

DEVICEA single working element for laser 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.