Thulium Fiber vs MOSES Holmium Laser for Enlarged Prostate

Overseen by Hazem Elmansy, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thunder Bay Regional Research Institute

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares two laser treatments for men with an enlarged prostate. These treatments aim to remove excess prostate tissue with less bleeding and faster recovery than traditional methods. One treatment uses a Thulium laser, while the other uses a Holmium laser.

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.

What data supports the effectiveness of the treatment MOSES Holmium Laser and Thulium Fiber Laser for enlarged prostate?

Research shows that both MOSES Holmium Laser and Thulium Fiber Laser are effective for treating benign prostatic hyperplasia (BPH), a condition where the prostate is enlarged. Studies indicate that these laser technologies are safe and improve surgical and functional outcomes for patients undergoing prostate procedures. ^{1 2 3 4 5}

Is the Thulium Fiber Laser and MOSES Holmium Laser safe for treating an enlarged prostate?

Research shows that both the Thulium Fiber Laser and MOSES Holmium Laser are generally safe for treating an enlarged prostate, with studies indicating no significant differences in complication rates between these technologies. ^{1 4 5 6 7}

How does the Thulium Fiber vs MOSES Holmium Laser treatment for enlarged prostate differ from other treatments?

The Thulium Fiber and MOSES Holmium Laser treatments for enlarged prostate are unique because they use advanced laser technology to precisely target and remove prostate tissue, potentially offering more precision and less bleeding compared to traditional surgical methods. These lasers are designed to improve the efficiency and safety of the procedure, which may lead to quicker recovery times and fewer complications. ^{8 9 10 11 12}

Research Team

Hazem Elmansy, MD

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• MOSES Holmium Laser (Laser Therapy)
• Thulium Fibre Laser (Laser Therapy)

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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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 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]

References

1. Italy 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. [2022]

2. Germany 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. [2023]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficiency and clinical outcomes of Moses technology for holmium laser enucleation of the prostate: An evidence-based analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

MOSESTM Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Utilization of MOSES Modulated Pulse Mode Results in Improved Efficiency in Holmium:YAG Laser Ablation of the Prostate. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Robotic versus thoraco-laparoscopic minimally invasive Ivor Lewis esophagectomy, a matched-pair single-center cohort analysis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Robot-assisted minimally invasive esophagectomy. German version]. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Robot-assisted minimally invasive esophagectomy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Feasibility of transthoracic esophagectomy with a next-generation surgical robot. [2023]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Postesophagectomy Diaphragmatic Prolapse after Robot-Assisted Minimally Invasive Esophagectomy (RAMIE). [2023]