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Greenlight Vaporization vs Xpeeda Vaporesection

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Xpeeda Fibre Laser Vaporesection of the Prostate
Greenlight XPS Vaporization of the Prostate
Sponsored by
Thunder Bay Regional Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Greenlight XPS Vaporization

Xpeeda Fibre Laser Vaporesection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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).
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).
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).

Secondary Outcome Measures

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.
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.
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).
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).
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).

Full Information

First Posted
May 4, 2020
Last Updated
October 18, 2022
Sponsor
Thunder Bay Regional Health Research Institute
Collaborators
Northern Ontario School of Medicine, Thunder Bay Regional Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04386941
Brief Title
Greenlight Vaporization vs Xpeeda Vaporesection
Official Title
Holmium Laser Xpeeda Vaporesection Versus Greenlight XPS Vaporization of the Prostate for Benign Prostatic Obstruction: A Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
July 10, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thunder Bay Regional Health Research Institute
Collaborators
Northern Ontario School of Medicine, Thunder Bay Regional Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized clinical study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Greenlight XPS Vaporization
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Xpeeda Fibre Laser Vaporesection
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Xpeeda Fibre Laser Vaporesection of the Prostate
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Greenlight XPS Vaporization of the Prostate
Intervention Description
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 Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
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).
Time Frame
Baseline
Title
International Prostate Symptom Score (IPSS)
Description
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).
Time Frame
1 month post-op
Title
International Prostate Symptom Score (IPSS)
Description
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).
Time Frame
3 months post-op
Title
International Prostate Symptom Score (IPSS)
Description
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).
Time Frame
6 months post-op
Title
International Prostate Symptom Score (IPSS)
Description
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).
Time Frame
12 months post-op
Title
Quality of life (QOL) Due to Urinary Symptoms
Description
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.
Time Frame
Baseline
Title
Quality of life (QOL) Due to Urinary Symptoms
Description
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.
Time Frame
1 month post-op
Title
Quality of life (QOL) Due to Urinary Symptoms
Description
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.
Time Frame
3 months post-op
Title
Quality of life (QOL) Due to Urinary Symptoms
Description
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.
Time Frame
6 months post-op
Title
Quality of life (QOL) Due to Urinary Symptoms
Description
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.
Time Frame
12 months post-op
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
Baseline
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
Immediately post-catheter removal
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
1 month post-op
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
3 months post-op
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
6 months post-op
Title
Peak flow rate (Qmax)
Description
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.
Time Frame
12 months post-op
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
Baseline
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
Immediately post-catheter removal
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
1 month post-op
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
3 months post-op
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
6 months post-op
Title
Post-void residual urine volume (PVR)
Description
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
Time Frame
12 months post-op
Title
Prostate specific antigen (PSA)
Description
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).
Time Frame
Baseline
Title
Prostate specific antigen (PSA)
Description
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).
Time Frame
3 months post-op
Title
Prostate specific antigen (PSA)
Description
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).
Time Frame
12 months post-op
Secondary Outcome Measure Information:
Title
Rates of intraoperative adverse events
Description
Rates of complications, such as incidence of bleeding, need for use of monopolar diathermy, duration of surgery, and the operative time/ laser time ratio.
Time Frame
During surgery
Title
Degree of prostatic size change measured by transrectal ultrasound (TRUS)
Description
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.
Time Frame
Surgery and 3-months post-op
Title
International index of erectile function-5 (IIEF-5)
Description
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).
Time Frame
Surgery
Title
International index of erectile function-5 (IIEF-5)
Description
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).
Time Frame
3 months post-op
Title
International index of erectile function-5 (IIEF-5)
Description
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).
Time Frame
12 months post-op

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem Elmansy, MD
Organizational Affiliation
Thunder Bay Regional Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional Health Sciences Centre/Thunder Bay Regional Health Research Institute
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B6V4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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

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