HoLEP versus bipolar enucleation for men with large prostates
Official title: Holmium Laser Versus Bipolar Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Large Prostates: A Non-inferiority Prospective Randomized Clinical Trial
Run by Assiut University · NCT06759194 · Data updated 2026-11-12
This will test whether bipolar enucleation works as well as Holmium Laser Enucleation (HoLEP) for men over 50 with large prostates who need surgery for BPH.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | Men only |
| Enrollment | 98 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | July 24, 2025 |
| Trial ID | NCT06759194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men older than 50 with prostate volume greater than 80 mL, significant LUTS (IPSS >15) or urinary retention, reduced peak urine flow (Qmax <15 mL/s), and failure or intolerance of medical therapy are ideal candidates.
✕Probably not a fit
Patients with active urinary tract infection, known prostate or bladder cancer, urethral stricture, neurogenic bladder disorders, or prior prostate enucleation (redo cases) are excluded and unlikely to benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, non-inferiority trial comparing HoLEP and bipolar enucleation in men with large prostates who have failed medical therapy. Eligible participants are randomized to receive either Holmium Laser Enucleation or Bipolar Enucleation, with perioperative metrics, symptom scores (IPSS), urinary flow (Qmax), complications, blood loss, and catheterization time tracked. Outcomes will focus on short- and mid-term efficacy and safety to determine if bipolar enucleation offers comparable results to HoLEP. The trial recruits and follows patients at Assiut University Urology Hospital.
Why it matters
Potential benefit: If successful, bipolar enucleation could offer a lower-cost, more widely available surgical option with similar symptom relief and safety to HoLEP.
How similar studies have gone: HoLEP is an established effective technique and bipolar enucleation has shown promising results in non-randomized series, but randomized head-to-head non-inferiority data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>50 years * Prostate volume \>80 ml * Failure of or noncompliance with medical treatment * IPSS \>15 * Qmax \<15 ml/sec * Urinary retention and fixed catheters with poor results on trial of voiding without catheter Exclusion Criteria: * Patients with active UTI * Prostate cancer * Bladder carcinoma * Urethral stricture * Neurogenic bladder disorders * Redo cases
Where it's running
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Assiut University Urology Hospital
Asyut, Egypt Recruiting
Study contacts
- Principal investigator: Mostafa M. Mostafa, M.D. — Assiut University
- Study coordinator: Mostafa M. Mostafa, M.D.
- Email: mostafaabdelaziz91@gmail.com
- Phone: +201000740478
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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.