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NCT Number: NCT07349147

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

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.

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Key information

Conditions

Prostate Hyperplasia Genital Diseases Genital Diseases, Male Laser Prostate Enucleation Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Thulium Fiber Laser Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Gaziantep,

Gaziantep, Gazi̇antep, 27310, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic Benign Prostatic Hyperplasia (BPH) refractory to medical treatment.
  • Prostate volume > [e.g., 40] ml.
  • Patients providing written informed consent for the prospective follow-up

Exclusion criteria

  • Neurogenic bladder dysfunction.
  • Active urinary tract infection at the time of surgery.

Treatment and study plan

Thulium Fiber Laser (TFL) Enucleation

Device

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.

Primary outcomes

  1. Learning Curve Competency

    Time frame: 12 month

    The point at which the surgeon achieves a stable enucleation efficiency (grams of tissue/minute) and a significant reduction in operative time.

Sponsors and collaborators

Lead sponsor

Muharrem Baturu

Other

Registry information

Acronym: ThuFLEP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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