One surgical working element for both bipolar and laser prostate enucleation.
Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Menoufia University Academic / other |
| Locations | 1 site (Shibīn al Kawm, Menoufia) |
| Trial ID | NCT07020364 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shibīn al Kawm, Menoufia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.