Thulium Fiber vs MOSES Holmium Laser for Enlarged Prostate

Overseen By Rabail Siddiqui, MPH, MHSc

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thunder Bay Regional Research Institute

Disqualifiers: Prostate cancer, Urethral stenosis, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Intra-Op

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two laser treatments for men with an enlarged prostate, which can lead to bladder and urination issues. It compares the Thulium Fiber Laser, known for its cutting-edge technology, with the MOSES Holmium Laser, which is already in use and results in less blood loss and shorter hospital stays. The researchers aim to determine if these treatments offer similar recovery times and outcomes. Men who may qualify have persistent urination problems due to an enlarged prostate and have not found success with non-surgical treatments. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments that could enhance quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Thulium Fiber Laser (TFL) offers a promising and safe option for treating an enlarged prostate. One study found that TFL effectively removes prostate tissue, regardless of size, and is generally safe. Patients experienced minimal blood loss and recovered quickly.

Similarly, the MOSES Holmium Laser has demonstrated positive results. Studies indicate it is efficient and safe for prostate treatment, often allowing shorter treatment times and quick recovery, with many patients returning home the same day. No major safety issues were identified compared to standard treatments.

Both lasers appear to be safe alternatives to traditional surgery. The TFL, being newer, requires further research to fully understand its benefits and limitations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using lasers for treating enlarged prostate because these technologies offer new ways to address the condition. The Thulium Fibre Laser (TFL) is known for its precision and ability to minimize bleeding during the procedure, potentially leading to quicker recovery times. On the other hand, the MOSES Holmium Laser is designed to improve energy transmission efficiency, which might result in shorter operation times and more effective tissue removal. Both treatments represent advancements over traditional surgical methods, promising fewer complications and enhanced patient outcomes.

What evidence suggests that this trial's treatments could be effective for benign prostatic hyperplasia?

This trial will compare the Thulium Fiber Laser (TFL) and the MOSES Holmium Laser for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Research has shown that the Thulium Fiber Laser is a promising treatment, significantly improving symptoms, urinary flow, and overall quality of life for patients. It is safe and effective, particularly for larger prostate glands.

Research on the MOSES Holmium Laser indicates it can shorten surgery times and improve recovery. This laser technology often allows for quicker procedures, enabling many patients to go home the same day. Both lasers, tested in separate arms of this trial, provide safer and faster alternatives to traditional methods, with less blood loss and shorter hospital stays. ^{1 2 3 4 6}

Who Is on the Research Team?

Hazem Elmansy, MD

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for men over 50 with severe urinary symptoms from an enlarged prostate (BPH) who haven't improved with medication. They must have a prostate size of ≥80 ml, be able to follow study procedures, and give informed consent in English. Men with urethral stenosis history, prostate cancer, active infections or previous BPH surgery are excluded.

Inclusion Criteria

IPSS >15 and QOL score ≥3 and Qmax <15 ml/sec

I am a man over 50 years old.

My prostate was measured to be 80 ml or larger before surgery.

Exclusion Criteria

I have had urethral stenosis or treatment for it.

I can understand and consent to the study in English.

My prostate is smaller than 80 mL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo treatment using either Thulium Fiber Laser (TFL) or MOSES Holmium Laser for prostate enucleation

Intra-Op

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months post-operation

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MOSES Holmium Laser
• Thulium Fibre Laser

Trial Overview The study compares two laser treatments for BPH: Thulium Fiber Laser (TFL) enucleation and Holmium MOSES Laser enucleation. It aims to see if they're equally effective in reducing hospital stay time and improving intraoperative and postoperative outcomes.

How Is the Trial Designed?

Group I: Thulium Fibre Laser (TFL) Experimental Treatment 1 Intervention

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

Group II: MOSES Holmium Laser Experimental Treatment 1 Intervention

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

MOSES Holmium Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in European Union as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in Canada as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Who Is Running the Clinical Trial?

Thunder Bay Regional Research Institute

Lead Sponsor

Trials

9

Recruited

620+

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Published Research Related to This Trial

In a study of 185 patients who underwent Ivor Lewis Robot-assisted minimally invasive esophagectomy (IL-RAMIE), 5.9% developed postesophagectomy diaphragmatic prolapse (PDP), typically presenting around 241 days post-surgery with symptoms like reflux and pain.

The treatment of PDP using a minimally invasive approach was found to be safe and effective, with 91% of patients undergoing successful revisional surgery and a manageable average hospital stay of 12 days, although there was a recurrence rate of 36%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postesophagectomy Diaphragmatic Prolapse after Robot-Assisted Minimally Invasive Esophagectomy (RAMIE). Brunner, S., Müller, DT., Eckhoff, JA., et al.[2023]

In a study involving 236 patients (118 each for MoLEP and ThuFLEP), both Holmium laser with MOSES technology and Thulium fiber laser enucleation of the prostate were found to be safe and effective, with similar short-term surgical outcomes and complication rates.

At the 12-month mark, patients who underwent MoLEP experienced a significantly greater reduction in their International Prostate Symptom Score (IPSS), indicating better long-term symptom relief compared to those who had ThuFLEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser with MOSES technology (MoLEP) vs Thulium fiber laser enucleation of the prostate (ThuFLEP) in a real-world setting. Mid-term outcomes from a multicenter propensity score analysis. Castellani, D., Di Rosa, M., Gómez Sancha, F., et al.[2023]

In a study of 176 ureteroscopy cases, the use of Moses technology with the Lumenis Pulse P120H holmium laser did not significantly improve procedural efficiency compared to the regular mode, as measured by procedural time, fragmentation time, and energy used.

There were no significant differences in complication rates or stone-free rates between the Moses and regular modes, suggesting that while Moses technology may have potential benefits, they were not evident in this analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. Knoedler, MA., Li, S., Best, SL., et al.[2022]

The use of MOSES technology in holmium laser ablation of the prostate (HoLAP) significantly improved ablation efficiency, with a rate of 0.86 g/min compared to 0.59 g/min without MOSES, indicating a more effective procedure.

Despite the increased efficiency with MOSES, postoperative outcomes such as symptom scores, quality of life, and complications were similar between the two groups, suggesting that MOSES enhances procedural efficiency without compromising patient safety or short-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of MOSES Modulated Pulse Mode Results in Improved Efficiency in Holmium:YAG Laser Ablation of the Prostate. Whiles, BB., Martin, AJ., Brevik, A., et al.[2023]

In a study of 82 patients undergoing surgery for benign prostatic hyperplasia, the MOSESTM technology showed significantly shorter operative times compared to the thulium fiber laser (TFL), indicating a more efficient surgical option.

Both MOSESTM and TFL demonstrated comparable safety and postoperative outcomes, such as urinary function and complication rates, suggesting that MOSESTM is an effective alternative for treating BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Elmansy, H., Hodhod, A., Elshafei, A., et al.[2022]

Moses laser enucleation of the prostate (MoLEP) demonstrated significant advantages over holmium laser enucleation of the prostate (HoLEP) in terms of shorter hemostasis, enucleation, and operative times, as well as reduced intraoperative blood loss and hospital stay, based on a meta-analysis of 12 studies involving 1160 patients.

MoLEP also resulted in a lower total postoperative complications rate compared to HoLEP, although both procedures showed similar outcomes in terms of symptom relief and urinary function, indicating MoLEP may be a safer and more efficient option for treating benign prostatic hyperplasia (BPH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency and clinical outcomes of Moses technology for holmium laser enucleation of the prostate: An evidence-based analysis. Li, K., Meng, C., Li, J., et al.[2023]

In a study comparing minimally invasive esophagectomy (MIE) techniques, robotic surgery showed a significant reduction in complications (Clavien-Dindo Grade 2 or above) compared to conventional thoracoscopy-laparoscopy, with rates of 41.8% vs 59.7% respectively, indicating better safety outcomes for the robotic approach.

Robotic MIE also resulted in a shorter hospital stay (median of 7 days vs 8 days for TL) and a trend towards fewer anastomotic leaks, suggesting improved efficacy and recovery for patients undergoing this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus thoraco-laparoscopic minimally invasive Ivor Lewis esophagectomy, a matched-pair single-center cohort analysis. Chouliaras, K., Attwood, K., Brady, M., et al.[2023]

The SuperPulse Thulium fiber laser (SP TFL) is an effective and safe treatment for small calyceal stones in the lower pole of the kidney, achieving a stone-free rate of 86.6% after 90 days in a study of 15 patients.

The use of small laser fibers allows for better maneuverability during flexible ureteroscopy, enabling successful treatment even in challenging anatomical conditions, with a low complication rate of 6.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. Rapoport, LM., Gazimiev, MA., Korolev, DO., et al.[2021]

Robot-assisted minimally invasive esophagectomy (RAMIE) is a safe and effective surgical option for treating resectable esophageal cancer, showing good oncologic results and reduced postoperative complications.

RAMIE expands the possibilities for curative surgery, making it suitable for patients with more advanced conditions, such as T4b tumors and lymph node metastases after neoadjuvant treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robot-assisted minimally invasive esophagectomy. German version]. van Hillegersberg, R., Seesing, MF., Brenkman, HJ., et al.[2018]

Robot-assisted minimally invasive esophagectomy (RAMIE) is a safe and effective surgical option for treating resectable esophageal cancer, showing good oncologic results and reduced postoperative complications.

RAMIE expands the possibilities for curative surgery, making it suitable for patients with more advanced conditions, such as T4b tumors and lymph node metastases after neoadjuvant treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted minimally invasive esophagectomy. van Hillegersberg, R., Seesing, MF., Brenkman, HJ., et al.[2022]

In a study involving 57 patients, robot-assisted transthoracic esophagectomy (TTE) using the Versius Surgical System was successfully performed without any unplanned conversions to other surgical methods, indicating its feasibility and effectiveness.

The procedure resulted in minimal estimated blood loss and no reported complications or deaths, highlighting the safety of this robotic surgical approach for major esophageal resections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transthoracic esophagectomy with a next-generation surgical robot. Puntambekar, S., Bharambe, S., Pawar, S., et al.[2023]

In a study of 60 patients, holmium laser enucleation of the prostate using MOSES technology significantly reduced total operative time (101 minutes vs. 126 minutes) and enucleation times compared to traditional methods, indicating improved efficiency in the procedure.

The MOSES technology also resulted in less blood loss and shorter hemostasis times, while maintaining similar functional outcomes and safety profiles compared to traditional holmium laser enucleation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MOSESTM Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Controlled Trial. Kavoussi, NL., Nimmagadda, N., Robles, J., et al.[2021]

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/laser-therapies/moses-technology.html

Lumenis Pulse™ 120H Holmium Laser System Treat kidney stones and BPH with the Lumenis Pulse 120H Holmium Laser System with MOSES 2.0 Technology. It delivers remarkable efficiency and versatility.

2. bostonscientific.com bostonscientific.com/en-US/products/lithotripsy/Lumenis-PulseTM-120H.html

Lumenis Pulse™ 120H - Holmium Laser Lithotripsy For benign prostatic hyperplasia (BPH) treatments, MOSES Technology has been shown to result in significantly shorter treatment time due to improved enucleation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9486436/

Comparative efficacy and safety of holmium laser ... Moses HoLEP demonstrated superiority in post operative outcome of lower PVR. •. Moses HoLEP possessed no safety issues compared to standard HoLEP. 1.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456922000360

Does MOSES Technology Enhance the Efficiency and ... We found that the MOSES laser system can improve intraoperative performance, making prostate treatment a same-day discharge surgery.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004954/

A review of the Moses effect and its applications in ... The MOSES™ technology has also been applied in holmium laser enucleation of the prostate, reducing enucleation and hemostasis times, leading to improved ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20570885&pc=GEX

MAUDE Adverse Event Report: LUMENIS LTD MOSES PULSE The study concludes that holmium laser enucleation of the prostate is a safe, effective and durable procedure to treat benign prostatic hyperplasia during long- ...