A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber… (NCT07627178) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
Egypt90 participantsStarted 2025-10-21
Plain-language 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.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Prostate Symptom Score (IPSS)
Timeframe: at 1, 3 and 6 months post-surgery
2
Quality of Life Score (QoL)
Timeframe: Baseline and at 1, 3, and 6 months post-surgery
3
Maximum Urinary Flow Rate (Qmax)
Timeframe: Baseline and at 1, 3, and 6 months post-surgery
4
Post-Void Residual Urine Volume (PVR)
Timeframe: Baseline and at 1, 3, and 6 months post-surgery