NCT07349147

Thulium Fiber Laser Enucleation of the Prostate: Learning Curve and Functional Outcomes - A Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Muharrem Baturu · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The aim of this prospective study is to evaluate the learning curve and functional outcomes of Thulium Fiber Laser Enucleation of the Prostate (TfLEP) performed by a single surgeon. The study focuses on surgical efficiency, safety (complication rates), and the improvement of lower urinary tract symptoms (LUTS) and quality of life over a 12-month follow-up period.

Detailed description

Thulium Fiber Laser (TFL) is an emerging technology in the field of laser prostatectomy. While Holmium Laser Enucleation (HoLEP) is well-established, the learning curve and long-term functional stability of TFL need further prospective validation. This study will involve the first \[Insert Number, e.g., 100\] consecutive cases of TfLEP. The "Learning Curve" will be analyzed using Cumulative Sum (CUSUM) analysis of enucleation efficiency and operative time. Functional outcomes will be assessed via IPSS, Qmax, and IIEF-5 scores at baseline and post-operative intervals (1, 3, and 12 months).

Conditions

• Prostate Hyperplasia
• Thulium Fiber Laser
• Laser Prostate Enucleation

Interventions

Type	Name	Description
DEVICE	Thulium Fiber Laser (TFL) Enucleation	Surgical enucleation of the prostate using TFL technology to achieve complete removal of the transition zone adenoma, aiming for symptomatic relief and improvement in urinary flow.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-10-01
• Completion: 2026-01-01
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Turkey (Türkiye)