What is the mechanism of action of this treatment?

Laser-based treatments for an enlarged prostate, such as Thulium Fiber Laser Enucleation (ThuFLEP) and Holmium Laser Enucleation of the Prostate (HoLEP), utilize high-energy lasers to precisely remove excess prostate tissue. These lasers create a vaporization bubble that destroys prostatic tissue with minimal deep tissue penetration, reducing the risk of bleeding and other complications. ThuFLEP, in particular, uses a high wavelength and pulsed mode of action, which allows for efficient and safe enucleation of large prostate volumes. These treatments are significant for BPH patients as they offer minimally invasive options with shorter hospital stays, reduced catheterization times, and lower risks of perioperative bleeding, making them suitable for patients on anticoagulation therapy.

What side effects are associated with this type of intervention?

Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP) and Holmium Laser Enucleation of the Prostate (HoLEP) are advanced treatments for benign prostatic hyperplasia (BPH). Common side effects of these laser-based treatments include transient stress urinary incontinence, which is usually temporary, and a longer operative time compared to traditional methods like Transurethral Resection of the Prostate (TURP). Both ThuFLEP and HoLEP are associated with minimal blood loss, shorter catheterization times, and decreased hospital stays. However, there is a risk of perioperative bleeding complications, though this is generally lower than with TURP. Additionally, patients on anticoagulation therapy may experience slightly longer durations of bladder irrigation and hospital stays.

What prior FDA approvals exist?

The FDA has approved several laser-based treatments for benign prostatic hyperplasia (BPH), including Holmium Laser Enucleation of the Prostate (HoLEP) and Photoselective Vaporization of the Prostate (PVP). These treatments, like Thulium Fiber Laser Enucleation (ThuFLEP), use laser energy to remove or vaporize excess prostate tissue, thereby relieving urinary symptoms. HoLEP, in particular, is known for its efficacy in treating large prostate volumes with minimal bleeding risk, similar to the high wavelength and pulsed mode of action seen in ThuFLEP.

What other types of research exist?

Promising novel alternatives to Thulium Fiber Laser Enucleation (ThuFLEP) for treating an enlarged prostate in 2024 include Holmium Laser Enucleation of the Prostate (HoLEP) with MOSES technology, which offers efficient tissue removal with minimal blood loss, and Robotic Waterjet Treatment (RWT), which uses a high-velocity waterjet for precise tissue ablation while sparing major blood vessels.

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Laser Therapy

Thulium Fiber vs MOSES Holmium Laser for Enlarged Prostate

N/A

Recruiting

Led By Hazem Elmansy, MD

Research Sponsored by Thunder Bay Regional Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of urethral stenosis or its management

Prostate size < 80 mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,3,6,12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include bleeding requiring blood transfusion, late postoperative bleeding similar to TURP complications but expected less due to the nature of laser treatments which typically result in minimal blood loss.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had urethral stenosis or treatment for it.

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My prostate is smaller than 80 mL.

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I have had surgery for an enlarged prostate.

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I have a history of prostate cancer.

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I have bladder control issues due to nerve problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3,6,12 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3,6,12 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3,6,12 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in size

International Prostate Symptom Score

Operative time

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Thulium Fibre Laser (TFL)Experimental Treatment1 Intervention

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

Group II: MOSES Holmium LaserExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thulium Fibre Laser

2022

N/A

~190

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Laser-based treatments for an enlarged prostate, such as Thulium Fiber Laser Enucleation (ThuFLEP) and Holmium Laser Enucleation of the Prostate (HoLEP), utilize high-energy lasers to precisely remove excess prostate tissue. These lasers create a vaporization bubble that destroys prostatic tissue with minimal deep tissue penetration, reducing the risk of bleeding and other complications. ThuFLEP, in particular, uses a high wavelength and pulsed mode of action, which allows for efficient and safe enucleation of large prostate volumes. These treatments are significant for BPH patients as they offer minimally invasive options with shorter hospital stays, reduced catheterization times, and lower risks of perioperative bleeding, making them suitable for patients on anticoagulation therapy.

Thulium Fiber Laser Enucleation of the Prostate: Prospective Study of Mid- and Long-Term Outcomes in 1328 Patients.Novel Thulium Fiber Laser for Enucleation of Prostate: A Retrospective Comparison with Open Simple Prostatectomy.Enucleation of the prostate for benign prostatic hyperplasia thulium laser versus holmium laser: a systematic review and meta-analysis.