One surgical working element for both bipolar and laser prostate enucleation.
Official title: Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
Run by Menoufia University · NCT07020364 · Data updated 2026-11-12
This will test whether one surgical tool can safely and effectively be used for both bipolar and laser prostate enucleation in men with BPH and a prostate volume of 40 cc or larger.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 50 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | September 30, 2025 |
| Study ends | November 1, 2025 |
| Registry record updated | June 13, 2025 |
| Trial ID | NCT07020364 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with symptomatic BPH requiring surgical enucleation, a prostate volume ≥40 cc on ultrasound, no prior prostate cancer, and without active infections, prior prostate surgery, coagulation disorders, long-term anticoagulation, or urethral strictures.
✕Probably not a fit
Patients with prostate cancer, prostate volume under 40 cc, active urinary tract infection, prior prostate surgery, coagulation problems or long-term anticoagulation, or anatomical urethral abnormalities are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center feasibility project will observe men with BPH and prostate volume ≥40 cc who are scheduled for enucleation to see how a single interchangeable working element performs with both bipolar and laser energy. Surgeons will use the same working element during bipolar and laser enucleation procedures while investigators record intraoperative events, device performance, and immediate safety outcomes. The study excludes men with active urinary infections, prior prostate surgery, coagulation disorders, long-term anticoagulation, known urethral strictures, or prostate cancer. No randomization or therapeutic comparison is planned; the primary focus is real-time feasibility and safety signals to inform later trials.
Why it matters
Potential benefit: If successful, the device could simplify prostate enucleation procedures, reduce instrument changes, and potentially lower operative time and costs for patients.
How similar studies have gone: Bipolar and laser enucleation techniques are well established individually, but using a single working element for both modalities is novel and has limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Menoufia Faculty of Medicine
Shibīn al Kawm, Menoufia, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed K Omar, Assistant professor
- Email: kimo_81eg@yahoo.com
- Phone: +201066949454
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.