Actively Recruiting
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
Led by Menoufia University · Updated on 2025-06-13
60
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility and safety of using a single working element device compatible with both bipolar and laser enucleation techniques in prostate surgery for patients with benign prostatic hyperplasia (BPH). The study will focus on real-time assessment of this new device to ensure its safe and effective integration before larger clinical trials are conducted. The investigation is led by Menoufia University and targets males aged 50 years and older with prostate enlargement requiring surgery. Participants will be divided into two groups: one using bipolar enucleation where bipolar energy is applied for cutting and coagulation, and the other using laser enucleation with either Thulium or Holmium lasers for tissue dissection and hemostasis. Both groups will use the same single working element device designed to work with both energy types. This prospective study will observe the operative time and safety over a one-month period. During the study, participants will undergo surgical procedures with the assigned enucleation technique using the single device. Researchers will monitor operative time, safety outcomes, and effectiveness at one month post-procedure. They will also analyze costs associated with the operative time. The total participation involves preoperative assessment, the surgery itself, and follow-up evaluations to measure the device's performance and patient safety.
CONDITIONS
Brief Title
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical intervention
- Prostate volume 40 cc or larger as assessed by transrectal ultrasound
- No prior history of prostate cancer
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgery event
Participants undergo prostate enucleation surgery using a single working element device with either bipolar energy or laser modalities for tissue dissection and hemostasis.
1 surgical procedure visit
Duration - 1 month
Participants are monitored for safety and efficacy outcomes following surgery.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, Egypt, 13829
Actively Recruiting
Research Team
M
Mohamed K Omar, Assistant professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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