Recruiting

TFL vs. Holmium MOSES

Sponsor:

Thunder Bay Regional Health Research Institute

Code:

NCT05240001

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Thulium Fibre Laser

MOSES Holmium Laser

Study Details

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

Study ID

NCT05240001

Start date

Apr 20, 2022

Status verified date

Aug, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Apr, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Thulium Fibre Laser (TFL)

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

experimental: MOSES Holmium Laser

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

Interventions

Thulium Fibre Laser

Participants will undergo treatment using the TFL

MOSES Holmium Laser

Participants will undergo treatment using the MOSES Holmium laser.

Primary outcome measure

  • Length of stay in the hospital [ Time Frame: within 6 hours ]

Central Contacts and Locations

Central contacts

Rabail Siddiqui, MPH, MHSc

(807) 684-6608siddiqur@tbh.net

Locations

Thunder Bay Regional Health Sciences Centre

Recruiting

Thunder Bay, Ontario, Canada, P7B 6V4

Contacts

Rabail Siddiqui, MPH, MHSc

siddiqur@tbh.net

More Information

Sponsor

Thunder Bay Regional Health Research Institute

Last update posted

Aug 16, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thunder Bay Regional Health Research Institute on 2024-08-16.