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

Muharrem Baturu

Status: Completed

Conditions: Prostate Hyperplasia; Thulium Fiber Laser; Laser Prostate Enucleation

Treatments: Device: Thulium Fiber Laser (TFL) Enucleation

Study type: Interventional

Funder types: Other

Identifiers

NCT07349147

2026/01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 85 patients

Sex: Male

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Thulium Fiber Laser Enucleation of the Prostate (ThuFlEP) Group

Experimental group

Description:

All patients in this study group will undergo Thulium Fiber Laser Enucleation of the Prostate (TfLEP) for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH). The surgical procedure involves using a 60-watt Thulium Fiber Laser (TFL) system to enucleate the prostatic adenoma in a retrograde or antegrade fashion. Following enucleation, the adenoma is removed from the bladder using a mechanical morcellator. The study will monitor the surgeon's performance from the first consecutive case to evaluate the learning curve (measured by operative efficiency) and assess functional outcomes (IPSS, Qmax, and Quality of Life) at post-operative intervals of 1, 3, and 12 months.

Treatment:

Device: Thulium Fiber Laser (TFL) Enucleation