HoLEP versus bipolar enucleation for men with large prostates
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyut) |
| Trial ID | NCT06759194 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Asyut
- 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
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.