NCT07627178Recruiting
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 26 May 2026
- Start date
- 21 Oct 2025
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Tanta University
- NCT number
- NCT07627178
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 21 Oct 2025 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate surgery
- Previous urethral surgery.
- Previous pelvic radiation.
Other illness
- Prostate cancer (current or history).
- Active urinary tract infection.
- Severe cardiovascular disease (ASA Class IV).
Other
- Neurogenic bladder dysfunction.
- Urethral stricture
- Urinary bladder stones.
Who the study is looking for
- 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
Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta University Hospital Coordinator of this site? Confirm its status | Tanta | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.