Greenlight Vaporization vs Xpeeda Vaporesection

NCT04386941 | Completed

• 1 other identifier: RP-582
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is a common problem, which impact patients' quality of life. It may lead to serious outcomes, including urinary tract infection, hematuria, bladder stones, urinary retention, hydronephrosis, and rarely renal insufficiency. Introduction of the Holmium laser enucleation of the prostate (HoLEP) represented a turning point in minimally invasive laser therapy for BPH as it achieves size-independent prostatic cavities similar to simple open prostatectomy with significantly lower perioperative morbidity. Recently, 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. To date, no outcomes of the new Xpeeda laser fiber have been reported in the literature, which is striving for trials comparing XPS 180W with other competitors such as Holmium vaporesection with the new fiber Xpeeda. Therefore, this study is planned to compare both procedures in improving bothersome LUTS secondary to BPH, and to evaluate safety and cost effectiveness.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (25)

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  Baseline

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  1 month post-op

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  3 months post-op

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  6 months post-op

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).

  12 months post-op

• Quality of life (QOL) Due to Urinary Symptoms

  One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

  Baseline

• Quality of life (QOL) Due to Urinary Symptoms

  One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

  1 month post-op

• Quality of life (QOL) Due to Urinary Symptoms

  One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

  3 months post-op

• Quality of life (QOL) Due to Urinary Symptoms

  One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

  6 months post-op

• Quality of life (QOL) Due to Urinary Symptoms

  One question asking; "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that? Scored from 0-6 with 0 being "delighted" and 6 being "terrible". Higher the score, the lower the quality of life.

  12 months post-op

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  Baseline

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  Immediately post-catheter removal

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  1 month post-op

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  3 months post-op

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  6 months post-op

• Peak flow rate (Qmax)

  Indicates the maximum urine flow rate. In men peak flow rates (Qmax) greater than 15-20 ml/second are considered normal, rates less than 10 ml/second are considered abnormal. This is measured by Uroflowmetry, also called a uroflow test, which measures the flow and force of urine stream during urination.

  12 months post-op

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  Baseline

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  Immediately post-catheter removal

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  1 month post-op

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  3 months post-op

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  6 months post-op

• Post-void residual urine volume (PVR)

  The amount of urine retained in the bladder after a voluntary void. Incomplete bladder emptying is diagnosed by postvoid catheterization or ultrasonography showing an elevated residual urine volume. A volume \< 50 mL is normal; \< 100 mL is usually acceptable in patients \> 65 but abnormal in younger patients

  12 months post-op

• Prostate specific antigen (PSA)

  The PSA test Measures the level of PSA (protein produced by normal, as well as malignant, cells of the prostate gland) in a blood sample. The normal PSA value is usually stated to be less than 4.0 μg/L. However, because of the fact that benign enlargement of the prostate gland tends to occur as men get older, an age-adjusted scale has been developed: 0-2.5 μg/L = Normal for a man 40-50 yrs; 2.5-3.5 μg/L = Normal for a man 50-60 yrs. For men aged 70 to 79, they suggested a normal serum PSA reference range of 0.0-6.5 ng/mL (0.0-6.5 μg/L).

  Baseline

• Prostate specific antigen (PSA)

  The PSA test Measures the level of PSA (protein produced by normal, as well as malignant, cells of the prostate gland) in a blood sample. The normal PSA value is usually stated to be less than 4.0 μg/L. However, because of the fact that benign enlargement of the prostate gland tends to occur as men get older, an age-adjusted scale has been developed: 0-2.5 μg/L = Normal for a man 40-50 yrs; 2.5-3.5 μg/L = Normal for a man 50-60 yrs. For men aged 70 to 79, they suggested a normal serum PSA reference range of 0.0-6.5 ng/mL (0.0-6.5 μg/L).

  3 months post-op

• Prostate specific antigen (PSA)

  The PSA test Measures the level of PSA (protein produced by normal, as well as malignant, cells of the prostate gland) in a blood sample. The normal PSA value is usually stated to be less than 4.0 μg/L. However, because of the fact that benign enlargement of the prostate gland tends to occur as men get older, an age-adjusted scale has been developed: 0-2.5 μg/L = Normal for a man 40-50 yrs; 2.5-3.5 μg/L = Normal for a man 50-60 yrs. For men aged 70 to 79, they suggested a normal serum PSA reference range of 0.0-6.5 ng/mL (0.0-6.5 μg/L).

  12 months post-op

Secondary Outcomes (5)

• Rates of intraoperative adverse events

  During surgery

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

  Surgery and 3-months post-op

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

  Surgery

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

  3 months post-op

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

  12 months post-op

Study Arms (2)

Greenlight XPS Vaporization

ACTIVE COMPARATOR

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.

Procedure: Greenlight XPS Vaporization of the Prostate

Xpeeda Fibre Laser Vaporesection

ACTIVE COMPARATOR

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.

Procedure: Xpeeda Fibre Laser Vaporesection of the Prostate

Interventions

Xpeeda Fibre Laser Vaporesection of the Prostate PROCEDURE

Both interventions are currently used standard of care treatments for the Holmium laser enucleation of the prostate (HoLEP) for patients with bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). 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.

Xpeeda Fibre Laser Vaporesection

Greenlight XPS Vaporization of the Prostate PROCEDURE

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.11 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 fibers required in these situations.

Greenlight XPS Vaporization

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males over 50 years of age at the time of enrollment
• Referred to urology for refractory LUTS secondary to BPH
• Prostate size on preoperative TRUS of 40-80 ml
• IPSS \>15, QOL score ≥3 and Qmax \<15 ml/sec
• Written informed consent to participate in the study
• Ability to comply with the requirements of the study procedures

You may not qualify if:

• Previous surgical treatment for BPH
• Presence of bladder stones
• History of prostate cancer
• Prostate size \> 80 mL or \<40 mL
• History of urethral stenosis or its management
• Known or suspected neurogenic bladder
• Participants with active urinary tract infection until appropriately treated
• Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
• Participants who are uncooperative or cannot follow instructions.
• Participants who lack the capacity to provide free and informed written consent.

Sponsors & Collaborators

• Thunder Bay Regional Health Research Institute: lead
• Northern Ontario School of Medicine: collaborator
• Thunder Bay Regional Health Sciences Centre: collaborator

Study Sites (1)

Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute

Thunder Bay, Ontario, P7B6V4, Canada

Location

Related Publications (1)

• Elmansy H, Zakaria AS, Hodhod A, Shabana W, Ahmad A, Oquendo F, Fathy M, Abbas L, Abdul Hadi R, Kelly R, Kotb A, Shahrour W. Holmium Laser Xpeeda Vaporization vs GreenLight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: 1-Year Results from a Randomized Controlled Clinical Study. J Endourol. 2023 Jun;37(6):706-712. doi: 10.1089/end.2022.0727. Epub 2023 May 22.

  PMID: 37029802 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hazem Elmansy, MD

  Thunder Bay Regional Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urology Surgeon

Model Details: Prospective randomized clinical study

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 13, 2020
• Study Start: July 31, 2019
• Primary Completion: July 10, 2022
• Study Completion: July 31, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)