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

Study Overview
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Brief Summary
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Thulium Fibre Laser
* Device: MOSES Holmium Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thulium Fibre Laser (TFL)<br>Patients randomized to this arm will undergo treatment using the TFL. | Device: Thulium Fibre Laser<br>* Participants will undergo treatment using the TFL<br>|
| Experimental: MOSES Holmium Laser<br>Patients randomized to this arm will undergo treatment using the MOSES Holmium laser. | Device: MOSES Holmium Laser<br>* Participants will undergo treatment using the MOSES Holmium laser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the hospital |  | within 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of bleeding |  | Intra-Op | 
| Incidence of blood transfusion |  | Intra-Op | 
| Operative time | Including laser use time | Intra-Op | 
| International Prostate Symptom Score | Eight questions (seven concerning urinary symptoms and one concerning quality of life), responses range from 0 (better outcome) to 5 (worse outcome), with total score ranging from 0 to 35. | 1,3,6,12 months post-op | 
| Quality of Life (QOL) as scored on the International Prostate Symptom Score (IPSS) | Response to the last question on the IPSS: If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Response ranging from 'Delighted' to 'Terrible'. | 1,3,6,12 months post-op | 
| Peak flow rate | Qmax | 1,3,6,12 months post-op | 
| Post-void residual | PVR | 1,3,6,12 months post-op | 
| Prostate specific antigen | PSA | 1,3,6,12 months post-op | 
| Change in size | Assessed by TRUS | 6 months | 
| Time to Catheter Removal |  | within 4 hours |