NCT05240001

Thulium Fiber Laser (TFL) vs Holmium MOSES for Treatment of Benign Prostatic Hyperplasia (BPH)

Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser Enucleation of the Prostate for Treatment of Benign Prostatic Hyperplasia (BPH): A Randomized Prospective Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Thunder Bay Regional Health Research Institute · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Benign prostatic hyperplasia (BPH), the non-cancerous enlargement of the prostate, places pressure on the urethra and causes urination and bladder problems. Transurethral Resection of the Prostate (TURP) remains the gold standard treatment in most centres for BPH. However, morbidity after TURP is high, especially bleeding requiring blood transfusion and late postoperative bleeding. Holmium laser enucleation of the prostate (HoLEP) is a safe and effective procedure which has demonstrated comparable results to TURP. HOLEP also offers patients the alternative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay. The main reason HoLEP has yet to become the new standard for treatment of symptomatic BPH is due the complexity of this procedure as compared to TURP. Furthermore, the HoLEP can be used with the MOSESTM system, a system that allows for more efficiency and ease of use of the HoLEP. Thulium fiber laser (TFL) enucleation of the prostate is an emerging technology for endoscopic prostate enucleation that is notable for its high wavelength and pulsed mode of action. Recent studies have shown TFL enucleation of the prostate to be a safe and highly efficacious treatment modality for the management of large volume (\> 80 cm3) glands in BPH. Due to its novelty, further studies are needed to broaden the investigators' understanding of the TFL and comprehend the full implications and benefits of this new technology, as well its limitations. The aim of this study is to whether Thulium Fiber laser enucleation of the prostate (ThuFLEP) and Holmium laser enucleation using MOSES™ (M-HoLEP) have comparable length of hospital stay, as well as intraoperative and postoperative outcomes.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DEVICE	Thulium Fibre Laser	Participants will undergo treatment using the TFL
DEVICE	MOSES Holmium Laser	Participants will undergo treatment using the MOSES Holmium laser.

Timeline

• Start date: 2022-04-20
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2022-02-15
• Last updated: 2024-08-16

Locations

1 site across 1 country: Canada