Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, Transurethral resection of the prostate, Lower urinary tract symptoms, GreenLight, Laserscope, Photoselective vaporization of the prostate, enlarged prostate
Brief summary
To gain clinical experience with the GreenLight HPS System, a system designed to vaporize and coagulate tissue in the treatment of benign prostatic hyperplasia to reduce lower urinary tract symptoms.
Detailed description
Enlarged prostate or Benign Prostatic Hyperplasia (BPH) is one of the most common diseases of aging men and can be associated with lower urinary tract symptoms (LUTS) such as having to urinate very often, a sudden strong feeling of having to urinate, having to get up at night to urinate, decreased and intermittent force of stream and the feeling of incomplete bladder emptying. These symptoms affect quality of life by interfering with normal daily activities and sleep patterns. When surgery is the best treatment option for the patient, the most common technique is a transurethral resection of the prostate (TURP). TURP involves removing the some of the extra tissue of the prostate gland. Even though TURP is a good treatment, there are concerns about the frequency of complications following treatment as well as the significant costs to patients, doctors, and insurance providers. Photoselective vaporization of the prostate (PVP) is a relatively new technology that has similar benefits with fewer side effects than TURP. PVP is a minimally invasive procedure that uses a special high-energy laser to eliminate excess prostate tissue and seal the treated area. This technology has been used for more than a decade with over 200,000 procedures performed worldwide. The focus of this study is to 1) document the long-term advantages of GreenLight HPS 120w and 2) to show that the stronger laser is a more flexible and efficient device which allows for a shorter procedure time, may be done in an out-patient setting in healthy patients, allows for shorter catheterization time, may result in a rapid urinary flow rate with minimal side effects, and may allow a quick return to normal activities. This device has been approved by the United States Food and Drug Administration (FDA) for treatment of obstructive BPH.
Interventions
DEVICEGreenLight HPS
Greenlight HPS laser system for treatment of BPH
Sponsors
American Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All male subjects ≥ 45 years of age who have a history of symptomatic/obstructive symptoms secondary to BPH greater than 3 months, an International Prostate Symptom Score (IPSS) / American Urology Association (AUA) score \>14, require surgical intervention, and are an acceptable risk for anesthesia and surgery are eligible to participate in this study
Exclusion criteria
* American Society of Anesthesiologists (ASA) classification of physical status \> III * An unstable cardiopulmonary disorder, previously or recently diagnosed by standard methods * A myocardial infarction or coronary artery stent placement within 6 months of the treatment * Neurogenic lower urinary dysfunction * A post-void residual (PVR) volume ≥ 400 mL * Pre-existing urinary incontinence * Active localized or systemic infection, including urinary tract infection (UTI) or prostatitis affecting bladder function * Pre-existing damage of external urinary sphincter * Presence of cystolithiasis, urethral stricture, or bladder neck contracture * Prostate volume (PV), as measured by transrectal ultrasound (TRUS), less than 30cc or greater than 200cc * Previously confirmed or suspected malignancy of prostate or bladder, treated or untreated * Immunocompromised subjects * Serious bleeding disorders and coagulopathy. For example: hemophilia or Von Willebrand's disease * Desire to preserve antegrade ejaculation * Calcification of prostate tissue, usually after severe prostatitis * Deemed unfit for laser vaporization as determined by the attending physician * Enrollment in a concurrent clinical trial of any treatment (drug or device) that could affect urogenital function without sponsors' approval * Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Success | 6 months | Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related Complication | 3 months | Treatment-related events include the following: * Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization * Perforation / injury of adjacent organ(s) * Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal * Hematuria requiring transfusion * Urinary retention requiring corrective intervention * De novo erectile dysfuction (ED) * Transfusion secondary to procedure-related anemia * Post procedure incontinence secondary to damage to the external urinary sphincter * Any other treatment-related injury requiring intervention |
| Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. | 6 months post-treatment | A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months. |
| Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 5 years | Participant response to the question 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?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes. |
| Gross Hematuria | 91 days | Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria. |
| Percentage of Participants With Treatment Success | 5 Years | Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point. |
| Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. | Up to five years | — |
| Occurrence of Retrograde Ejaculation | 5 Year Follow Up | Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation. |
| Percentage of Participants With Clinically-significant Improvement in Uroflow. | 6 months post-treatment | A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Procedure (LOP) | Procedure | Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes). |
| Length of Lasing (LOL) | Procedure | Total time the laser was on during the study procedure. |
| Number of Fibers Used During Procedure | Procedure | — |
| Total Joules Used | Procedure | Total energy applied during the study procedure |
| Length of Catheterization (LOC) | Recovery Period | Defined as the time the subject required an indwelling Foley catheter post treatment (in hours). |
| Length of Hospital Stay (LOS) | Peri-Operative Period | Defined as the time from admission to the healthcare facility until discharge (in hours). |
Countries
United States
Participant flow
Recruitment details
This study enrolled patients at least 45 years of age with symptomatic/obstructive BPH for at least 3 months and requiring surgical intervention. Enrollment occurred at 10 academic and private medical centers in the US. The last patient follow up visit was completed in August 2012. The last site close-out visit was completed January 2013.
Participants by arm
| Arm | Count |
|---|---|
| GreenLight HPS Laser System GreenLight HPS Laser System therapy for patients with BPH. | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Aborted Proc./Treatment Not Attempted | 3 |
| Overall Study | Change in health precluded follow up | 4 |
| Overall Study | Death | 3 |
| Overall Study | Did not meet study criteria | 4 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Other | 6 |
| Overall Study | Patient postponed procedure | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Pt. Insurance not accepted at center | 2 |
| Overall Study | Site closed due to IRB expiration | 1 |
| Overall Study | Unable to obtain IRB approval | 1 |
| Overall Study | Withdrawal by Subject | 25 |
| Overall Study | Withdrew consent prior to procedure | 3 |
Baseline characteristics
| Characteristic | GreenLight HPS Laser System |
|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 7.8 |
| Average Duration of Obstructive Symptoms (months) | 74.9 months STANDARD_DEVIATION 60.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 148 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 178.5 cm STANDARD_DEVIATION 7 |
| International Prostate Symptom Score (IPSS) at Baseline | 22.9 Scores on a scale STANDARD_DEVIATION 5.8 |
| Peak Flow Rate (ml/sec) | 10.7 ml/sec STANDARD_DEVIATION 5.4 |
| Post-void Residual Volume (ml) | 112.5 ml STANDARD_DEVIATION 115.5 |
| Previous BPH Treatment | 134 participants |
| Prostate Volume (cc) | 58.5 cc STANDARD_DEVIATION 28.4 |
| Region of Enrollment United States | 150 participants |
| Serum Prostate Specific Antigen (PSA) level (ng/ml) | 2.5 ng/ml STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 150 Participants |
| Smoker | 10 participants |
| Weight (kg) | 87.3 kg STANDARD_DEVIATION 14.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 97 / 136 |
| serious Total, serious adverse events | 35 / 136 |
Outcome results
Primary
Percentage of Participants With Treatment Success
Treatment success is determined on a per patient basis and is defined as \[(baseline I-PSS - I-PSS at 6-months)/ baseline I-PSS\] greater than or equal to 50%
Time frame: 6 months
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Percentage of Participants With Treatment Success | 84.9 percentage of participants |
Secondary
Gross Hematuria
Kaplan-Meier estimate of percentage of participants who require a blood transfusion as a result of hematuria.
Time frame: 91 days
Population: Participants who received the study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Gross Hematuria | 1.5 Percentage of subjects |
| 3 Months | Gross Hematuria | 2.2 Percentage of subjects |
Secondary
Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity.
Time frame: Up to five years
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Length of Time to Return to Pre-treatment Level of Physical Activity (in Days), Excluding Sexual Activity. | 9.5 days | Standard Deviation 9.6 |
Secondary
Occurrence of Retrograde Ejaculation
Kaplan-Meier estimate of percentage of participants who experience retrograde ejaculation.
Time frame: 5 Year Follow Up
Population: Participants who received the study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Occurrence of Retrograde Ejaculation | 43.3 percentage of subjects with RE |
Secondary
Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume.
A clinically significant improvement in post-void residual is defined as a decrease of at least 50ml from baseline to 6 months.
Time frame: 6 months post-treatment
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Percentage of Participants With Clinically-significant Improvement in Post-void Residual Urine Volume. | 42.7 percentage of patients improved |
Secondary
Percentage of Participants With Clinically-significant Improvement in Uroflow.
A clinically significant improvement in uroflow is defined as an increase in peak urinary flow rate (Qmax) of at least five ml/sec from baseline to 6 months
Time frame: 6 months post-treatment
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Percentage of Participants With Clinically-significant Improvement in Uroflow. | 70.9 percentage of patients improved |
Secondary
Percentage of Participants With Treatment Success
Treatment success is determined on a per patient basis and is defined as a 50% or greater decrease in IPSS from baseline to the specified time point.
Time frame: 5 Years
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Percentage of Participants With Treatment Success | 0 Percent of subjects w/ treatment success |
| 3 Months | Percentage of Participants With Treatment Success | 72.5 Percent of subjects w/ treatment success |
| 6 Months | Percentage of Participants With Treatment Success | 84.9 Percent of subjects w/ treatment success |
| 1 Year | Percentage of Participants With Treatment Success | 77.8 Percent of subjects w/ treatment success |
| 2 Years | Percentage of Participants With Treatment Success | 79.6 Percent of subjects w/ treatment success |
| 3 Years | Percentage of Participants With Treatment Success | 75.3 Percent of subjects w/ treatment success |
| 4 Years | Percentage of Participants With Treatment Success | 74.6 Percent of subjects w/ treatment success |
| 5 Years | Percentage of Participants With Treatment Success | 100.0 Percent of subjects w/ treatment success |
Secondary
Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years.
Participant response to the question 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?. Values range from 0 (Delighted) to 6 (Terrible) with higher values indicating worse outcomes.
Time frame: 5 years
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 4.4 Score on a scale | Standard Deviation 1.1 |
| 3 Months | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.6 Score on a scale | Standard Deviation 1.4 |
| 6 Months | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.3 Score on a scale | Standard Deviation 1.2 |
| 1 Year | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.3 Score on a scale | Standard Deviation 1.2 |
| 2 Years | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.3 Score on a scale | Standard Deviation 1.2 |
| 3 Years | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.3 Score on a scale | Standard Deviation 1.3 |
| 4 Years | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 1.2 Score on a scale | Standard Deviation 1.2 |
| 5 Years | Quality of Life Score (QoL) From I-PSS From Baseline Through 5 Years. | 0.8 Score on a scale | Standard Deviation 1 |
Secondary
Treatment-related Complication
Treatment-related events include the following: * Infection that requires IV antibiotics or re-hospitalization or prolongation of existing hospitalization * Perforation / injury of adjacent organ(s) * Bladder neck contracture(s) requiring re-catheterization after post-surgery catheter removal * Hematuria requiring transfusion * Urinary retention requiring corrective intervention * De novo erectile dysfuction (ED) * Transfusion secondary to procedure-related anemia * Post procedure incontinence secondary to damage to the external urinary sphincter * Any other treatment-related injury requiring intervention
Time frame: 3 months
Population: Participants who received the study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight HPS Laser System | Treatment-related Complication | 11.1 percentage of subjects with complication |
Other Pre-specified
Length of Catheterization (LOC)
Defined as the time the subject required an indwelling Foley catheter post treatment (in hours).
Time frame: Recovery Period
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Length of Catheterization (LOC) | 21.9 hours | Standard Deviation 22.9 |
Other Pre-specified
Length of Hospital Stay (LOS)
Defined as the time from admission to the healthcare facility until discharge (in hours).
Time frame: Peri-Operative Period
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Length of Hospital Stay (LOS) | 5.2 hours | Standard Deviation 7.1 |
Other Pre-specified
Length of Lasing (LOL)
Total time the laser was on during the study procedure.
Time frame: Procedure
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Length of Lasing (LOL) | 34.1 minutes | Standard Deviation 17.5 |
Other Pre-specified
Length of Procedure (LOP)
Defined as the time from cystoscope insertion into the urethra to the time of cystoscope removal (in minutes).
Time frame: Procedure
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Length of Procedure (LOP) | 53.9 minutes | Standard Deviation 21.5 |
Other Pre-specified
Number of Fibers Used During Procedure
Time frame: Procedure
Population: Participants who received the study treatment and for whom the outcome is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Number of Fibers Used During Procedure | 1.2 number of fibers used | Standard Deviation 0.5 |
Other Pre-specified
Total Joules Used
Total energy applied during the study procedure
Time frame: Procedure
Population: Participants who received the study treatment and for whom the outcome measure is available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight HPS Laser System | Total Joules Used | 190.6 kilojoules (kJ) | Standard Deviation 94.4 |