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NCT Number: NCT04386941

Greenlight Vaporization vs Xpeeda Vaporesection

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases Urological Manifestations

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Thunder Bay, Ontario, P7B6V4, Canada

About this study

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. Symptoms of BPH are due to prostatic enlargement, increased smooth muscle tone from the bladder and prostate, and changes in bladder contractility leading to lower urinary tract obstruction, which may cause permanent kidney damage if left untreated.

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. It has successfully passed the steps of validation through a growing number of well-designed randomized controlled studies to have a high level of evidence for safety and efficacy. The pulsed nature of holmium laser allows the plane of enucleation to be easier to develop and follow and gives superior visibility than the electro-cauterization with less charring of tissue.

HoLEP proved itself as the only endoscopic procedure with superior efficacy compared to the traditional transurethral resection of the prostate (TURP). Furthermore, it is not only safe, effective, size-independent and durable even in patients with coagulopathy, but also more cost-effective than TURP. Meta-analyses have confirmed how well established HoLEP has now become, with a low long-term retreatment rate and the more pronounced improvement in prostate symptoms score and flow rate than after TURP.

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. 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.

On the other hand, 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 fibres 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.

Elmansy et al reported that Greenlight vaporization and Holmium laser ablation of the prostate (HoLAP) are effective surgical treatments for BPH in small to medium prostates. The two techniques have similar functional outcomes and complication rates. Subjective and objective voiding parameters showed significant improvement lasting for up to 3 years, confirming the long lasting, durable effects of each technique.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. International Prostate Symptom Score (IPSS)

    Time frame: Baseline

    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).

  2. International Prostate Symptom Score (IPSS)

    Time frame: 1 month post-op

    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. International Prostate Symptom Score (IPSS)

    Time frame: 3 months post-op

    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).

  4. International Prostate Symptom Score (IPSS)

    Time frame: 6 months post-op

    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).

  5. International Prostate Symptom Score (IPSS)

    Time frame: 12 months post-op

    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. Quality of life (QOL) Due to Urinary Symptoms

    Time frame: Baseline

    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.

  7. Quality of life (QOL) Due to Urinary Symptoms

    Time frame: 1 month post-op

    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.

  8. Quality of life (QOL) Due to Urinary Symptoms

    Time frame: 3 months post-op

    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.

  9. Quality of life (QOL) Due to Urinary Symptoms

    Time frame: 6 months post-op

    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.

  10. Quality of life (QOL) Due to Urinary Symptoms

    Time frame: 12 months post-op

    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.

  11. Peak flow rate (Qmax)

    Time frame: Baseline

    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. Peak flow rate (Qmax)

    Time frame: Immediately post-catheter removal

    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.

  13. Peak flow rate (Qmax)

    Time frame: 1 month post-op

    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.

  14. Peak flow rate (Qmax)

    Time frame: 3 months post-op

    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.

  15. Peak flow rate (Qmax)

    Time frame: 6 months post-op

    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.

  16. Peak flow rate (Qmax)

    Time frame: 12 months post-op

    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.

  17. Post-void residual urine volume (PVR)

    Time frame: Baseline

    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

  18. Post-void residual urine volume (PVR)

    Time frame: Immediately post-catheter removal

    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

  19. Post-void residual urine volume (PVR)

    Time frame: 1 month post-op

    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

  20. Post-void residual urine volume (PVR)

    Time frame: 3 months post-op

    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

  21. Post-void residual urine volume (PVR)

    Time frame: 6 months post-op

    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

  22. Post-void residual urine volume (PVR)

    Time frame: 12 months post-op

    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

  23. Prostate specific antigen (PSA)

    Time frame: Baseline

    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).

  24. Prostate specific antigen (PSA)

    Time frame: 3 months post-op

    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).

  25. Prostate specific antigen (PSA)

    Time frame: 12 months post-op

    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).

Secondary outcomes

  1. Rates of intraoperative adverse events

    Time frame: During surgery

    Rates of complications, such as incidence of bleeding, need for use of monopolar diathermy, duration of surgery, and the operative time/ laser time ratio.

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

    Time frame: Surgery and 3-months post-op

    An ultrasound probe is inserted into the rectum to check the prostate. The probe bounces sound waves off body tissues to make echoes that form a sonogram (computer picture) of the prostate. Sonogram at baseline will be compared to that at 3-months post-op and prostate size measured using online measuring tools.

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

    Time frame: Surgery

    The 5-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multidimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes. Questions are scored from 1-5, with lower scores indicating increased levels of erectile dysfunction, while higher scores indicate higher erectile function. The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

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

    Time frame: 3 months post-op

    The 5-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multidimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes. Questions are scored from 1-5, with lower scores indicating increased levels of erectile dysfunction, while higher scores indicate higher erectile function. The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

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

    Time frame: 12 months post-op

    The 5-question International Index of Erectile Function (IIEF) Questionnaire is a validated, multidimensional, self-administered investigation that has been found useful in the clinical assessment of erectile dysfunction and treatment outcomes. Questions are scored from 1-5, with lower scores indicating increased levels of erectile dysfunction, while higher scores indicate higher erectile function. The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction (ED) is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

Sponsors and collaborators

Lead sponsor

Thunder Bay Regional Health Research Institute

Other

Collaborators

  • Northern Ontario School of Medicine
  • Thunder Bay Regional Health Sciences Centre

Registry information

Official study title

Holmium Laser Xpeeda Vaporesection Versus Greenlight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: A Randomized Controlled Clinical Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2024
First posted
May 13, 2020
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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