← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-op

Awards & highlights

Study Summary

This trial is important to show if the new laser fiber technology is an improvement over the old one.

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.Check my eligibility

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.See study design

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

Select...

I am a man over 50 years old.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

International Prostate Symptom Score (IPSS)

Peak flow rate (Qmax)

Post-void residual urine volume (PVR)

+2 more

Secondary outcome measures

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

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

Rates of intraoperative adverse events

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thunder Bay Regional Health Research InstituteLead Sponsor

8 Previous Clinical Trials

737 Total Patients Enrolled

Thunder Bay Regional Research InstituteLead Sponsor

8 Previous Clinical Trials

737 Total Patients Enrolled

Northern Ontario School of MedicineOTHER

10 Previous Clinical Trials

825 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation presently enrolling new participants?

"Clinicaltrials.gov confirms that this investigation is no longer recruiting participants, having originally been posted on July 31st 2019 and last updated October 18th 2022. Despite the closure of registration for this study, 156 other trials are still actively seeking volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Greenlight Vaporization vs Xpeeda Vaporesection

Hazem Elmansy 2019. "Greenlight Vaporization vs Xpeeda Vaporesection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04386941.

All > Benign Prostatic Hyperplasia > Bph