NCT07627178 A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
| NCT ID | NCT07627178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tanta University |
| Condition | Benign Prostatic Hyperplasia (BPH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-10-21 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (\>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.
Eligibility 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.
Contact & Investigator
Hassan Hussein El-Tatawy, MD
STUDY DIRECTOR
Tanta University Faculty of Medicine
Frequently Asked Questions
Who can join the NCT07627178 clinical trial?
This trial is open to male participants only, studying Benign Prostatic Hyperplasia (BPH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07627178 currently recruiting?
Yes, NCT07627178 is actively recruiting participants. Contact the research team at abdullah.aldebeiky@med.tanta.edu.eg for enrollment information.
Where is the NCT07627178 trial being conducted?
This trial is being conducted at Tanta, Egypt.
Who is sponsoring the NCT07627178 clinical trial?
NCT07627178 is sponsored by Tanta University. The principal investigator is Hassan Hussein El-Tatawy, MD at Tanta University Faculty of Medicine. The trial plans to enroll 90 participants.