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NCT Number: NCT07020364

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

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.

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Key information

Conditions

Prostate BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Menoufia Faculty of Medicine

Shibīn al Kawm, Menoufia, 13829, Egypt

Location status: Recruiting

Location contact

Mohamed k Omar, Assistant professor

CONTACT

[email protected]

+201066949454

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A single working element for bipolar enucleation

Device

Device: A single working element compatible with both bipolar and laser modalities.

The bipolar energy will be used for cutting and coagulation during enucleation.

A single working element for laser enucleation

Device

Device: A single working element compatible with both bipolar and laser modalities.

Thulium or Holmium laser will be employed for tissue dissection and hemostasis.

Primary outcomes

  1. Feasibility

    Time frame: the operative time

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

  2. Safety

    Time frame: 1 month

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

Secondary outcomes

  1. Efficacy

    Time frame: 1 month

    Operative time. Enucleation efficiency (grams of tissue removed per minute). Postoperative symptom improvement measured using International Prostate Symptom Score (IPSS).

  2. Cost Analysis

    Time frame: the operative time

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed K Omar, Assistant professor

CONTACT

[email protected]

+201066949454

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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