Benign Prostatic HyperplasiaNCT04386941
Greenlight Vaporization vs Xpeeda Vaporesection
A study testing Xpeeda Fibre Laser Vaporesection of the Prostate and Greenlight XPS Vaporization of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Xpeeda Fibre Laser Vaporesection of the Prostate and Greenlight XPS Vaporization of the Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2019to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
Thunder Bay, Ontario, P7B6V4
About this study
Official title: Holmium Laser Xpeeda Vaporesection Versus Greenlight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: A Randomized Controlled Clinical 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.
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Xpeeda Fibre Laser Vaporesection of the Prostate, Greenlight XPS Vaporization of the Prostate
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpeeda Fibre Laser Vaporesection of the ProstateProcedure or surgery
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 ProstateProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Xpeeda Fibre Laser Vaporesection of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months post-op
Secondary outcomes (5)
Rates of intraoperative adverse events
Rates of complications, such as incidence of bleeding, need for use of monopolar diathermy, duration of surgery, and the operative time/ laser time ratio.
Measured: During surgery
Degree of prostatic size change measured by transrectal ultrasound (TRUS)
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.
Measured: Surgery and 3-months post-op
International index of erectile function-5 (IIEF-5)
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).
Measured: Surgery
International index of erectile function-5 (IIEF-5)
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).
Measured: 3 months post-op
International index of erectile function-5 (IIEF-5)
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).
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start31 Jul 2019
- Primary completion10 Jul 2022
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thunder Bay Regional Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Ontario School of Medicine, Thunder Bay Regional Health Sciences Centre
- Responsible party
- Principal investigator, Hazem Elmansy, Thunder Bay Regional Health Research Institute
- Investigators
- Hazem Elmansy, MD, Principal investigator, Thunder Bay Regional Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386941
- Sponsor's protocol ID
- RP-582
- Status last verified
- Apr 2025
- First submitted
- 4 May 2020
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share any participant data with other researchers. Investigator findings may be presented at various national and international conferences, however all data will be de-identified and grouped prior to any dissemination, in an effort to protect participant confidentiality
Publications
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.
PubMed 37029802
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holmium Laser Xpeeda Vaporesection Versus Greenlight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04386941
- Acronym / sponsor ID
- RP-582
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Thunder Bay Regional Health Research InstituteUniversity, hospital or other
- Collaborators
- Northern Ontario School of Medicine, Thunder Bay Regional Health Sciences Centre
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Greenlight XPS Vaporization | Active comparator | Procedure: Greenlight XPS Vaporization of the ProstateGreenlight 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. |
| Xpeeda Fibre Laser Vaporesection | Active comparator | Procedure: Xpeeda Fibre Laser Vaporesection of the ProstateHolmium 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpeeda Fibre Laser Vaporesection of the ProstateBoth 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. | Procedure or surgery | Xpeeda Fibre Laser Vaporesection |
| Greenlight XPS Vaporization of the ProstateThe 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. | Procedure or surgery | Greenlight XPS Vaporization |
Primary outcome
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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).
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).
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).
5 secondary outcomes
Rates of intraoperative adverse events
Time frame: During surgery
Degree of prostatic size change measured by transrectal ultrasound (TRUS)
Time frame: Surgery and 3-months post-op
International index of erectile function-5 (IIEF-5)
Time frame: Surgery
International index of erectile function-5 (IIEF-5)
Time frame: 3 months post-op
International index of erectile function-5 (IIEF-5)
Time frame: 12 months post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 37029802Elmansy 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.
- Individual participant dataSharing planned: No. The investigators do not plan to share any participant data with other researchers. Investigator findings may be presented at various national and international conferences, however all data will be de-identified and grouped prior to any dissemination, in an effort to protect participant confidentiality
Related trials for Benign Prostatic Hyperplasia
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hazem Elmansy, MD principal investigator
Thunder Bay Regional Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xpeeda Fibre Laser Vaporesection of the Prostate and Greenlight XPS Vaporization of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Thunder Bay Regional Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) (time frame: Baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04386941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.