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

Menoufia University

Status: Enrolling

Conditions: Prostate; BPH (Benign Prostatic Hyperplasia)

Treatments: Device: A single working element for laser enucleation; Device: A single working element for bipolar enucleation

Study type: Observational

Funder types: Other

Identifiers

NCT07020364

Enucleation of prostate

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

60 participants in 2 patient groups

Bipolar Enucleation

Description:

Bipolar Enucleation Group: The bipolar energy will be used for cutting and coagulation during enucleation.

Treatment:

Device: A single working element for bipolar enucleation

Laser Enucleation

Description:

Laser Enucleation Group: Thulium or Holmium laser will be employed for tissue dissection and hemostasis.

Treatment:

Device: A single working element for laser enucleation