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

NCT05240001 | Recruiting

• 1 other identifier: RP-775
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Length of stay in the hospital

  within 6 hours

Secondary Outcomes (10)

• Incidence of bleeding

  Intra-Op

• Incidence of blood transfusion

  Intra-Op

• Operative time

  Intra-Op

• International Prostate Symptom Score

  1,3,6,12 months post-op

• Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS)

  1,3,6,12 months post-op

Study Arms (2)

Thulium Fibre Laser (TFL)

EXPERIMENTAL

Patients randomized to this arm will undergo treatment using the TFL.

Device: Thulium Fibre Laser

MOSES Holmium Laser

EXPERIMENTAL

Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.

Device: MOSES Holmium Laser

Interventions

Thulium Fibre Laser DEVICE

Participants will undergo treatment using the TFL

Thulium Fibre Laser (TFL)

MOSES Holmium Laser DEVICE

Participants will undergo treatment using the MOSES Holmium laser.

MOSES Holmium Laser

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males over 50 years of age at the time of enrollment
• Referred to urology for refractory LUTS or urinary retention secondary to BPH
• Failed medical (non-surgical) treatment
• Prostate size on preoperative TRUS of≥80 ml
• IPSS \>15 and QOL score ≥3 and Qmax \<15 ml/sec
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Previous surgical treatment for BPH
• History of prostate cancer
• Prostate size \< 80 mL
• History of urethral stenosis or its management
• Known or suspected neurogenic bladder
• Participants with active urinary tract infection until appropriately treated
• Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study
• Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead

Study Sites (1)

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hazem Elmansy, MD

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rabail Siddiqui, MPH, MHSc

CONTACT

(807) 684-6608; siddiqur@tbh.net

Hazem Elmansy, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 15, 2022
• Study Start: April 20, 2022
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)