Actively Recruiting
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Led by Tanta University · Updated on 2026-06-05
90
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of three different endoscopic techniques for removing large prostate tissue in men with benign prostatic hyperplasia (BPH) who experience severe urinary symptoms. The study focuses on men with prostate sizes over 100 mL who have not responded to medical treatments and have significant symptoms measured by the International Prostate Symptom Score (IPSS) and urinary flow rates. The trial is a prospective randomized controlled study conducted at Tanta University Hospital, evaluating three surgical methods used to treat large prostates causing lower urinary tract symptoms. Participants will be randomly assigned to one of three groups, each undergoing a different prostate enucleation procedure: Thulium Fiber Laser Enucleation (ThuFLEP) using a 60W thulium fiber laser, Holmium Laser Enucleation (HoLEP) using a 150W holmium YAG laser, or Bipolar Transurethral Enucleation (B-TUEP) using bipolar electrical energy. All procedures are performed transurethrally and involve removing the prostate tissue with a morcellator. Each group will have 30 patients, and the study will run from October 2025 to October 2027. Participants will undergo thorough preoperative assessments including symptom scores, urinary flow tests, ultrasounds, blood tests, and prostate-specific antigen measurements. After surgery, follow-ups at 1, 3, and 6 months will evaluate symptom relief, quality of life, urinary flow rate, residual urine volume, and erectile function. Researchers will also track operative times, blood loss, catheter duration, hospital stay, and complications categorized by the Clavien-Dindo system. The study measures both patient outcomes and surgical efficiency over six months post-operation.
CONDITIONS
Brief Title
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients diagnosed with benign prostatic hyperplasia (BPH)
- Clinical diagnosis of BPH with lower urinary tract symptoms
- Severe symptoms with International Prostate Symptom Score (IPSS) of 20 or higher
- Maximum urinary flow rate (Qmax) of 10 mL/s or less
- Prostate volume greater than 100 mL measured by transrectal ultrasound
- Failed medical therapy and fit for surgery
You will not qualify if you...
- Current or history of prostate cancer
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants undergo one of three types of transurethral prostate enucleation surgery using thulium fiber laser, holmium laser, or bipolar energy. Post-operative care includes catheterization and hospital stay lasting up to 7 days.
1 surgical procedure and hospital stay up to 7 days
Duration - 6 months
Participants are monitored at 1, 3, and 6 months after surgery to assess symptoms, quality of life, urinary flow, erectile function, and any complications.
3 follow-up visits at 1, 3, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Tanta University Hospital
Tanta, Gharbia Governorate, Egypt, 31111
Actively Recruiting
Research Team
A
Abdullah Salah Al Debeiky, MD
O
Omar Khaled Gad, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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