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

NCT ID: NCT07349147

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-01-01

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).

Conditions

Prostate Hyperplasia; Thulium Fiber Laser; Laser Prostate Enucleation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thulium Fiber Laser Enucleation of the Prostate (ThuFlEP) Group

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.

Group Type: EXPERIMENTAL

Thulium Fiber Laser (TFL) Enucleation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Muharrem Baturu

OTHER

Sponsor Role: lead

Responsible Party

Muharrem Baturu

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Gaziantep,

Gaziantep, Gazi̇antep, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2026/01

Identifier Type: -

Identifier Source: org_study_id