What is this study of laser and bipolar enucleation techniques studying for benign prostatic hyperplasia?

This study is comparing three surgical methods to treat large prostate enlargement causing severe urinary symptoms. Researchers aim to evaluate the safety and effectiveness of Thulium Fiber Laser, Holmium Laser, and Bipolar enucleation techniques. The trial is sponsored by Tanta University and focuses on improving treatment options for men with benign prostatic hyperplasia.

Who may be eligible for this benign prostatic hyperplasia clinical trial?

Men diagnosed with benign prostatic hyperplasia, experiencing severe urinary symptoms with an IPSS score of 20 or higher, a maximum urine flow rate of 10 mL/s or less, and prostate size over 100 mL may be eligible. Participants must have failed medical therapy and be fit for surgery. Please review eligibility criteria for more details.

Is there any cost to participate in this benign prostatic hyperplasia clinical trial?

Study-related care, including the surgical procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should prepare for any additional costs associated with attending the study visits.

Actively Recruiting

Phase Not Applicable

MALE

Healthy Volunteers

ID07627178

Comparing Safety and Effectiveness of Three Endoscopic Procedures for Large Prostate Treatment in Men with Severe Urinary Symptoms

Led by Tanta University · Updated on 2026-06-05

Participants Needed

Research Sites

25 weeks

Total Duration

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

MALE

Healthy Volunteers

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

Research Team

Abdullah Salah Al Debeiky, MD

Omar Khaled Gad, MSc

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