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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07349147

Acronym

ThuFLEP

Enrollment

Registered

2026-01-16

Start date

2024-01-01

Completion date

2026-01-01

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laser Prostate Enucleation, Prostate Hyperplasia, Thulium Fiber Laser

Keywords

ThuFlep, Prostate enucleation, learning curve, laser enucleation

Brief 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).

Interventions

DEVICEThulium 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Learning Curve Competency	12 month	The point at which the surgeon achieves a stable enucleation efficiency (grams of tissue/minute) and a significant reduction in operative time.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026