What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate, such as Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Fiber Laser Enucleation of the Prostate (TFLEP), are generally well-tolerated but can have side effects. These may include urinary incontinence, which is usually temporary, and urinary tract infections. Patients might also experience hematuria (blood in urine), bladder spasms, and, less commonly, erectile dysfunction. Both HoLEP and TFLEP aim to minimize these side effects by improving enucleation efficiency and hemostasis, with TFLEP potentially offering better hemostatic properties due to its optimal wavelength and shallow tissue penetration.

What prior FDA approvals exist?

The FDA has approved several treatments for benign prostatic hyperplasia (BPH), including laser-based techniques similar to m-HoLEP and TFLEP. Holmium Laser Enucleation of the Prostate (HoLEP) is a well-established method that uses a holmium: yttrium-aluminum-garnet (Ho: YAG) laser to remove prostate tissue, offering benefits such as reduced hospital stay and improved symptom scores. The Thulium Fiber Laser Enucleation of the Prostate (TFLEP) is a newer technique that uses a thulium fiber laser for more precise tissue removal and better hemostasis. Other FDA-approved treatments for BPH include medications like alpha-blockers and 5-alpha-reductase inhibitors, as well as minimally invasive surgical therapies such as transurethral resection of the prostate (TURP) and transurethral microwave therapy (TUMT).

What other types of research exist?

Promising novel alternatives to m-HoLEP and TFLEP for treating an enlarged prostate in 2024 include: 1) Bipolar Transurethral Resection of the Prostate (B-TURP) - offers similar efficacy to monopolar TURP with fewer adverse events and better hemostasis. 2) Prostatic Urethral Lift (PUL) - minimally invasive, preserves sexual function, and has a lower risk of complications. 3) Aquablation - uses waterjet ablation for precise tissue removal with minimal thermal damage, reducing the risk of complications. 4) Rezūm Water Vapor Therapy - minimally invasive, uses steam to ablate prostate tissue, and has a quick recovery time.

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Procedure

TFLEP vs m-HoLEP for Enlarged Prostate

N/A

Recruiting

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Patients with symptomatic benign prostate hyperplasia : urinary retention, acute renal failure (post-renal), refractory hematuria, repeated urinary tract infections, refractory symptoms.

Prostates between 50-300 grams,

Must not have

History of prostatic surgery,

Patients unfit for surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1-year post-operatively

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two laser treatments for men with enlarged prostates causing urinary problems. It aims to see which laser method, holmium with Moses technology or thulium fiber, is safer and more effective. The study will help doctors choose the best treatment for their patients.

Who is the study for?

Men with bothersome urinary symptoms due to an enlarged prostate (BPH), who haven't improved with medication, can join. They should have a prostate size between 50-300 grams and a urine flow rate of less than 15 ml/sec. Men who've had previous prostate/bladder surgery, cancer in these areas, or certain bladder conditions cannot participate.

What is being tested?

The study compares two laser technologies for treating BPH: m-HoLEP uses the Ho: YAG laser with Moses technology for better blood control; TFLEP uses thulium fiber laser which may offer similar benefits. The trial will assess safety and effectiveness up to one year after treatment.

What are the potential side effects?

Potential side effects from both procedures include bleeding, infection risk, temporary difficulty urinating or need for catheterization post-surgery, irritation during urination, erectile dysfunction, and rare cases of urinary incontinence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe symptoms from an enlarged prostate, like difficulty urinating or kidney issues.

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My prostate weighs between 50-300 grams.

Exclusion Criteria

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

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I have had surgery on my prostate.

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I am not a candidate for surgery due to my health condition.

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I have a history of prostate or bladder cancer.

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I am on blood thinners, but I can't stop them for surgery.

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I have a narrowed urethra.

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I have a condition where my bladder doesn't empty properly due to nerve problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1-year post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1-year post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1-year post-operatively for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To compare the hospital stay between the thulium fiber laser enucleation of the prostate (TFLEP) and the holmium:YAG laser enucleation of the prostate with Moses technology (m-HoLEP).

Secondary study objectives

To compare catheterization time between cohorts

To compare change in erectile function (IIEF) between cohorts

To compare drop in International Prostate Symptom Score (I-PSS) between cohorts

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Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: m-HoLEPActive Control1 Intervention

The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is the longest running and most studied laser used to perform this minimally invasive procedure. Holmium laser enucleation of the prostate reduces hospital stay and hemoglobin drop while improving IPSS and quality of life, as well as other positive postoperative outcomes compared to the historical gold standard, transurethral resection of the prostate (TURP). HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP). Patients will undergo m-HoLEP at the Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Nord-de-l'Île-de-Montréal as a treatment for benign prostate hyperplasia. The surgeon performing m-HoLEP is experienced in m-HoLEP procedures.

Group II: TFLEPActive Control1 Intervention

Thulium fiber laser (TFL) is a novel laser technology that delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. Patients will undergo thulium fiber laser enucleation of the prostate (TFLEP) at the Centre Hospitalier de l'Université de Montréal (CHUM) as a treatment for benign prostate hyperplasia. The surgeon performing TFLEP is experienced in TFLEP procedures.

0 / 8Eligibility 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 enucleation techniques, such as Holmium Laser Enucleation of the Prostate (HoLEP) and Thulium Fiber Laser Enucleation of the Prostate (TFLEP), work by using laser energy to remove excess prostate tissue that causes urinary obstruction. HoLEP, especially with Moses Technology, enhances enucleation efficiency and hemostasis by modulating pulsed laser energy, which reduces bleeding and improves surgical precision. TFLEP uses a thulium fiber laser that operates at an optimal wavelength with shallow tissue penetration, providing superior hemostatic properties. These mechanisms are crucial for patients with BPH as they minimize surgical risks, reduce hospital stays, and improve postoperative outcomes, leading to better symptom relief and quality of life.

[Comparative analysis of the effectiveness of various techniques of endoscopic prostate enucleation in a single center].