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

NCT07349147 | Completed

• 1 other identifier: 2026/01
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Hyperplasia; Thulium Fiber Laser; Laser Prostate Enucleation

Keywords

ThuFlep; Prostate enucleation; learning curve; laser enucleation

Outcome Measures

Primary Outcomes (1)

• Learning Curve Competency

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

  12 month

Study Arms (1)

Thulium Fiber Laser Enucleation of the Prostate (ThuFlEP) Group

EXPERIMENTAL

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.

Device: Thulium Fiber Laser (TFL) Enucleation

Interventions

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.

Thulium Fiber Laser Enucleation of the Prostate (ThuFlEP) Group

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Muharrem Baturu: lead

Study Sites (1)

University of Gaziantep,

Gaziantep, Gazi̇antep, 27310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)