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RecruitingNCT07020364Updated Jun 13, 2025

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

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
50 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate
  • BPH (Benign Prostatic Hyperplasia)

Keywords

  • laser enucleation
  • bipolar enucleation
  • BPH
  • prostate
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bipolar Enucleation

    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

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

    Device: A single working element for laser enucleation

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.

05

What researchers measure

Primary outcomes

  1. Feasibility

    Successful completion of enucleation using the single working element. Time taken to switch between bipolar and laser modalities.

    Time frame: the operative time

  2. Safety

    intraoperative complications (bleeding, urethral damage). Postoperative complications (infections, catheterization time, hospital stay).

    Time frame: 1 month

Secondary outcomes

  1. 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

  2. Cost Analysis

    Cost of using a single working element vs. standard separate tools for bipolar and laser.

    Time frame: the operative time

06

Study locations

1 of 1 sites recruiting
  • Menoufia Faculty of Medicine
    Shibin Al Kawm, Menoufia 13829, Egypt
    Recruiting
07

Registry details

Key details

Study ID
NCT07020364
Lead sponsor
Menoufia University
Responsible party
Mohamed Kamal Omar (Assistant professor, Menoufia University) — Principal investigator
First posted
Jun 13, 2025
Start date
Oct 1, 2024
Primary completion
Sep 30, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Jun 13, 2025

Study contacts

Mohamed K Omar, Assistant professor
Contact
kimo_81eg@yahoo.com
+201066949454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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