Bladder Outlet Obstruction Clinical Trials

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A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Egypt
Tanta University Hospital
RECRUITING
Tanta
Contact Information
Primary
Abdullah Salah Al Debeiky, MD
abdullah.aldebeiky@med.tanta.edu.eg
+201221430915
Backup
Omar Khaled Gad, MSc
omar_khaled@med.tanta.edu.eg
+201117837272
Time Frame
Start Date: 2025-10-21
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 90
Treatments
Active_comparator: ThuFLEP Group
30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber
Active_comparator: HoLEP Group
30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber
Active_comparator: Bipolar Enucleation Group
30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov