Compare three tools for removing large prostates: ThuFLEP, HoLEP, and B-TUEP
Official title: A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Run by Tanta University · NCT07627178 · Data updated 2026-11-12
This trial tests whether three endoscopic techniques for large prostate removal are safe and effective in men with severe urinary symptoms who have not improved with medicines.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Men only |
| Enrollment | 90 (estimated) |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | May 30, 2027 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07627178 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with BPH causing severe LUTS (IPSS ≥ 20, Qmax ≤ 10 mL/s) and prostate volume >100 mL who have not responded to medical therapy and are suitable for endoscopic enucleation.
✕Probably not a fit
Patients with prostate cancer, prior prostate or urethral surgery, neurogenic bladder, active urinary infection, or significant cardiovascular disease may have limited benefit or be excluded for safety reasons.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized trial compares Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation of the Prostate (B-TUEP) for prostates larger than 100 mL. Ninety men with severe LUTS due to BPH who failed medical therapy are randomized equally to the three arms and followed for 6 months. Primary outcomes include changes in IPSS, quality of life, maximal flow rate, and post-void residual at 1, 3, and 6 months. Secondary outcomes cover operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates by Clavien-Dindo. The study will be conducted at Tanta University Hospital with IRB-approved protocols.
Why it matters
Potential benefit: If successful, patients with large prostates may have safer procedures, faster recovery, and better symptom relief across the three techniques.
How similar studies have gone: Similar endoscopic enucleation comparisons have shown that laser and bipolar approaches can be effective, but direct head-to-head data for ThuFLEP, HoLEP, and B-TUEP in large prostates is limited and this trial aims to fill that gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients diagnosed with BPH * Clinical diagnosis of BPH with lower urinary tract symptoms. * IPSS ≥ 20 (severe symptoms) * Maximum urinary flow rate (Qmax) ≤ 10 mL/s * Prostate volume \>100 mL (measured by transrectal ultrasound) * Failed medical therapy and fit for operation Exclusion Criteria: * Prostate cancer (current or history). * Previous prostate surgery * Previous urethral surgery. * Neurogenic bladder dysfunction. * Active urinary tract infection. * Severe cardiovascular disease (ASA Class IV). * Previous pelvic radiation. * Urethral stricture * Urinary bladder stones.
Where it's running
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Tanta University Hospital
Tanta, Gharbia Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Abdullah Salah Al Debeiky, MD
- Email: abdullah.aldebeiky@med.tanta.edu.eg
- Phone: +201221430915
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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.