Recruiting NCT07020364
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: A single working element for bipolar enucleation, A single working element for laser enucleation.
- Who it may be relevant to
- Registry conditions: Prostate, BPH (Benign Prostatic Hyperplasia). Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device A 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. - Device A 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.
Primary outcome measures
- Feasibility [Time frame: the operative time]
- Safety [Time frame: 1 month]
Secondary outcome measures (2)
- Efficacy [Time frame: 1 month]
- Cost Analysis [Time frame: the operative time]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Menoufia Faculty of Medicine — Shibīn al Kawm
Identifiers
NCT: NCT07020364 · Enucleation of prostate