What is the mechanism of action of this treatment?

Common treatments for an enlarged prostate (BPH) include pharmacological and surgical options. Pharmacological treatments like alpha blockers relax the muscles in the prostate and bladder neck, easing urination, while 5-alpha reductase inhibitors shrink the prostate by blocking the conversion of testosterone to DHT. Surgical options, such as the Holmium Xpeeda side firing fibre, use laser energy to efficiently remove or vaporize excess prostate tissue, reducing urinary obstruction and minimizing vaporization time. Understanding these mechanisms helps patients make informed decisions about their treatment based on efficacy, side effects, and recovery time.

What side effects are associated with this type of intervention?

Common treatments for an enlarged prostate, such as Holmium laser enucleation and photoselective vaporization, generally have side effects that include urinary tract infections, bleeding, and temporary difficulty urinating. Other potential side effects are retrograde ejaculation, where semen enters the bladder instead of exiting through the penis, and erectile dysfunction. Minimally invasive laser treatments like the Holmium Xpeeda side firing fibre aim to reduce vaporization time and may offer a lower risk of these side effects, but comprehensive data on this specific technology is still pending.

What prior FDA approvals exist?

The FDA has approved several laser-based therapies for the treatment of benign prostatic hyperplasia (BPH), which are similar to the Holmium Xpeeda side firing fibre. These include the GreenLight laser therapy, which uses a high-powered laser to vaporize excess prostate tissue, and the Holmium Laser Enucleation of the Prostate (HoLEP), which removes obstructive prostate tissue with minimal perioperative morbidity. These treatments aim to improve lower urinary tract symptoms by reducing prostate size and relieving obstruction.

What other types of research exist?

Promising novel alternatives to the Holmium Xpeeda side firing fibre for treating an enlarged prostate include: 1) Aquablation, which uses a high-velocity water jet for tissue removal and has shown favorable outcomes in clinical trials. 2) Prostatic Arterial Embolization (PAE), which reduces blood flow to the prostate, causing it to shrink. 3) Transurethral Microwave Thermotherapy (TUMT), which uses microwave energy to destroy excess prostate tissue. These alternatives offer minimally invasive options with varying mechanisms of action and potential benefits.

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Laser Therapy

Greenlight Vaporization vs Xpeeda Vaporesection for Enlarged Prostate

N/A

Waitlist Available

Led By Hazem Elmansy, MD

Research Sponsored by Thunder Bay Regional Health Research Institute

Eligibility Criteria Checklist

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

Must have

Males over 50 years of age at the time of enrollment

Referred to urology for refractory LUTS secondary to BPH

Must not have

Previous surgical treatment for BPH

Prostate size > 80 mL or <40 mL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate a new laser technology for treating men with bothersome urinary symptoms caused by an enlarged prostate. The new laser is designed to be faster and more efficient by delivering energy directly to the tissue, which helps reduce procedure time and bleeding. The study will assess how well this new laser works compared to existing treatments.

Who is the study for?

Men over 50 with an enlarged prostate (40-80 ml in size) causing bothersome urinary symptoms, who haven't had previous BPH surgery, can join. They must understand and agree to the study's procedures and have a significant impact on their quality of life due to these symptoms.

What is being tested?

The trial is comparing two minimally invasive laser treatments for enlarged prostate: Greenlight XPS Vaporization and Xpeeda Fibre Laser Vaporesection. It aims to see which one better improves urinary symptoms while evaluating safety and cost-effectiveness.

What are the potential side effects?

Potential side effects may include irritation during urination, blood in urine, frequent urination, urgent need to urinate, or difficulty completely emptying the bladder. These are common after prostate procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am a man over 50 years old.

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I have been referred to a urologist for persistent urinary symptoms due to an enlarged prostate.

Exclusion Criteria

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

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I have had surgery for an enlarged prostate.

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My prostate size is either more than 80 mL or less than 40 mL.

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I have bladder stones.

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I have had urethral stenosis or treatment for it.

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I am unable to understand and sign the consent form on my own.

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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 ~ 12 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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.

Primary study objectives

International Prostate Symptom Score (IPSS)

Peak flow rate (Qmax)

Post-void residual urine volume (PVR)

+2 more

Secondary study objectives

Degree of prostatic size change measured by transrectal ultrasound (TRUS)

International index of erectile function-5 (IIEF-5)

Rates of intraoperative adverse events

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: Greenlight XPS VaporizationActive Control1 Intervention

Greenlight 532nm laser photoselective vaporization of the prostate (PVP) is an appealing treatment modality with hemoglobin as tissue target chromophore and relatively short learning curve. The introduction of the Xcelerated Performance System (XPS) 180W in 2010 with the MoXy fibers represents the highest-powered system currently in use for this type of laser. It encourages the adoption of the enucleation principle, making it a real contender to HoLEP in treating large adenomas. Despite the fact that large prostates often require more energy and longer operative time, the XPS system has reduced the operative time and number of fibres required in these situations.

Group II: Xpeeda Fibre Laser VaporesectionActive Control1 Intervention

Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue. Moreover, hemostasis would be improved by the pulse reshaping technology with a wider pulse width, activated by a dedicated footswitch. Therefore, the Lumenis Pulse™ 100W will make prostate vaporesection procedures more precise, faster and efficient, with excellent hemostasis. Consequently, bleeding is minimal, tissue is easier to remove and patients can have their catheter removed faster.

0 / 9Eligibility 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

Common treatments for an enlarged prostate (BPH) include pharmacological and surgical options. Pharmacological treatments like alpha blockers relax the muscles in the prostate and bladder neck, easing urination, while 5-alpha reductase inhibitors shrink the prostate by blocking the conversion of testosterone to DHT. Surgical options, such as the Holmium Xpeeda side firing fibre, use laser energy to efficiently remove or vaporize excess prostate tissue, reducing urinary obstruction and minimizing vaporization time. Understanding these mechanisms helps patients make informed decisions about their treatment based on efficacy, side effects, and recovery time.

A state-of-art review on the preservation of sexual function among various minimally invasive surgical treatments for benign prostatic hyperplasia: Impact on erectile and ejaculatory domains.The influence of the medical treatment of LUTS on benign prostatic hyperplasia surgery: do we operate too late?Pharmacological therapy of benign prostatic hyperplasia/lower urinary tract symptoms: an overview for the practising clinician.