Benign Prostatic Hyperplasia
Conditions
Brief summary
The purpose of this study is to gain information on the safety, efficacy, and quality of life in subjects who have had the GreenLight XPS procedure.
Detailed description
This is a retrospective chart review conducted at six centers in the United States and Canada. This review will evaluate the safety and efficacy of GreenLight XPS in subjects who received treatment on or after 01-Aug-2010.
Interventions
DEVICEGreenLight XPS Laser System
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Men who have had a GreenLight XPS procedure with a MoXy Fiber since 01-Aug-2010.
Exclusion criteria
* Subject has had prior radiation. * Subject has a diagnosis of neurogenic bladder confirmed by urodynamic studies (BOO, detrusor overactivity (DO), impaired detrusor contractor (IDC)) * Subject has a neurologic disorder that would impact bladder function (MS, Parkinson, Spinal Cord Injury) (note: Stroke patients not excluded) * Subject has an artificial urinary sphincter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 6 months post-procedure | Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of \>21 indicates the subject has severe symptoms. IPSS scores can range from 0-35. |
| Occurrence of Adverse Events Related to the Study Treatment. | 365 Days | Treatment-related adverse events include: * Event related to the study device or procedure * Intra-operative adverse event related to the study device or procedure * Serious adverse events related to the study device or procedure The number of events as well as the number and percentage of subjects with the event will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Changes in Quality of Life Related to BPH Symptoms. | Baseline through six months post-procedure | Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome. |
| Assess Changes in Objective Measures of Urologic Function. | Baseline through six months post-procedure. | Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax) |
| Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | Up to 90 days post-procedure. | * Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure * Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure * Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure |
| Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence | 90 days, 180 days | The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point. |
| Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. | Procedure through five years post-procedure. | Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal. |
| Characteristics of the Study Procedure | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. | Summary of the study procedure, including length of procedure and lasing time |
| Type of Hospital Stay | Data will be collected during the time of their hospital stay from admission through discharge | Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay) |
| Number of Participants Stratified by Number of Fibers Used During Procedure | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. | Summarize characteristics of the study procedure and immediate outcomes: number of fibers used |
| Assess Changes in Objective Measures of Urologic Function | Baseline through six months post-procedure | Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual |
| Changes in Objective Measures of Urologic Function | Baseline through six months post-procedure. | Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume |
| Length of Hospital Stay | The number of days from admission through discharge from the medical facility will be measured. | Summarize length of hospital stay (in days) from admission through discharge |
| Characteristics of the Study Procedure and Immediate Outcomes | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. | Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GreenLight XPS Laser System Treatment of BPH in men using the GreenLight XPS Laser System | 956 |
| Total | 956 |
Baseline characteristics
| Characteristic | GreenLight XPS Laser System |
|---|---|
| Age, Continuous | 68.6 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Canada | 199 participants |
| Region of Enrollment United States | 757 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 956 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 182 / 956 |
| serious Total, serious adverse events | 13 / 956 |
Outcome results
Primary
International Prostate Symptom Score (IPSS)
Evaluate the proportion of subjects who have mild or no BPH symptoms at six months post-procedure; e.g. an IPSS of eight or less at 6-month follow-up. An IPSS of eight or less indicates the subject is asymptomatic or has mild symptoms, a score of 9-21 indicates the subject has moderate symptoms, and a score of \>21 indicates the subject has severe symptoms. IPSS scores can range from 0-35.
Time frame: 6 months post-procedure
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GreenLight XPS Laser System | International Prostate Symptom Score (IPSS) | Score of <=8 | 437 Participants |
| GreenLight XPS Laser System | International Prostate Symptom Score (IPSS) | Score of 9-21 | 118 Participants |
| GreenLight XPS Laser System | International Prostate Symptom Score (IPSS) | Score of >21 | 17 Participants |
Primary
Occurrence of Adverse Events Related to the Study Treatment.
Treatment-related adverse events include: * Event related to the study device or procedure * Intra-operative adverse event related to the study device or procedure * Serious adverse events related to the study device or procedure The number of events as well as the number and percentage of subjects with the event will be calculated.
Time frame: 365 Days
Population: Number of participants with a treatment-related adverse event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight XPS Laser System | Occurrence of Adverse Events Related to the Study Treatment. | 249 Treatment-related Events |
Secondary
Assess Changes in Objective Measures of Urologic Function
Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual
Time frame: Baseline through six months post-procedure
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function | PVR Baseline (ml) | 204.3 ml | Standard Deviation 221.2 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function | PVR 6 Months (ml) | 46.1 ml | Standard Deviation 95.2 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function | PVR Change from Baseline | -172 ml | Standard Deviation 215.4 |
Secondary
Assess Changes in Objective Measures of Urologic Function.
Changes in objective measures of urologic function from baseline through six months post-procedure using Peak Flow Rate (Qmax)
Time frame: Baseline through six months post-procedure.
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | Peak Flow Rate (Qmax) Baseline (ml/sec) | 8.7 ml/sec | Standard Deviation 5.7 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | Qmax 6 months (ml/sec) | 18.0 ml/sec | Standard Deviation 8.9 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | Qmax Change from Baseline | 10.9 ml/sec | Standard Deviation 10 |
Secondary
Assess Changes in Objective Measures of Urologic Function.
Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen
Time frame: From baseline through six months post-procedure.
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | PSA (ng/ml) Baseline | 4.9 ng/ml | Standard Deviation 7.8 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | PSA (ng/ml) 6 Months | 2.6 ng/ml | Standard Deviation 7.6 |
| GreenLight XPS Laser System | Assess Changes in Objective Measures of Urologic Function. | PSA (ng/ml) Change from Baseline | -2.0 ng/ml | Standard Deviation 7.1 |
Secondary
Assess Changes in Quality of Life Related to BPH Symptoms.
Summarize IPSS-QOL from baseline through six months post-procedure for all data available during the retrospective review. The quality of life assessment responses includes: Delighted, Pleased, Mostly Satisfied, Mixed-neither satisfied or dissatisfied, Mostly Dissatisfied, Unhappy, or Terrible (range of 0 to 6).The results presented below represent the change from baseline to six months post-procedure for any response. Lower scores indicate a better outcome.
Time frame: Baseline through six months post-procedure
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS Laser System | Assess Changes in Quality of Life Related to BPH Symptoms. | 1.3 units on a scale | Standard Deviation 1.3 |
Secondary
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients.
Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.
Time frame: Procedure through five years post-procedure.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GreenLight XPS Laser System | Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. | Reobstruction due to prostate regrowth | 4 Participants |
| GreenLight XPS Laser System | Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. | Insufficient tissue removal | 3 Participants |
Secondary
Changes in Objective Measures of Urologic Function
Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume
Time frame: Baseline through six months post-procedure.
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS Laser System | Changes in Objective Measures of Urologic Function | Prostate Volume (g) Baseline | 76.0 grams | Standard Deviation 49 |
| GreenLight XPS Laser System | Changes in Objective Measures of Urologic Function | Prostate Volume (g) 6 Months | 44.0 grams | Standard Deviation 36.2 |
| GreenLight XPS Laser System | Changes in Objective Measures of Urologic Function | Prostate Volume (g) Change from Baseline | -31.8 grams | Standard Deviation 38.3 |
Secondary
Characteristics of the Study Procedure
Summary of the study procedure, including length of procedure and lasing time
Time frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS Laser System | Characteristics of the Study Procedure | Length of Procedure (minutes) | 57.1 minutes | Standard Deviation 28.6 |
| GreenLight XPS Laser System | Characteristics of the Study Procedure | Lasing Time (minutes) | 33.2 minutes | Standard Deviation 18.9 |
Secondary
Characteristics of the Study Procedure and Immediate Outcomes
Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)
Time frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS Laser System | Characteristics of the Study Procedure and Immediate Outcomes | 275.8 kJ | Standard Deviation 180.7 |
Secondary
Characteristics of the Study Procedure and Immediate Outcomes
Summarize characteristics of the study procedure and immediate outcomes: length of catheterization
Time frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GreenLight XPS Laser System | Characteristics of the Study Procedure and Immediate Outcomes | 1.2 days |
Secondary
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence
The percentage (count/n) of subjects with an ongoing urinary incontinence event at 90 and 180 days post-procedure. An incontinence event is considered ongoing if the onset was on or before the specified time point and the event is either unresolved or resolved after that time point.
Time frame: 90 days, 180 days
Population: This study was retrospective chart review of available data collected in the medical records. The intention was to collect and analyze data through five years post-procedure; however, the data collected was minimal. Results posted here are reflective of the results that have been published (through 6-months).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GreenLight XPS Laser System | Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence | Incontinence, Stress 90 Days | 0.9 percentage of incontinence events |
| GreenLight XPS Laser System | Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence | Incontinence, Urge 90 Days | 0.9 percentage of incontinence events |
| GreenLight XPS Laser System | Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence | Incontinence, Stress 180 Days | 1.3 percentage of incontinence events |
| GreenLight XPS Laser System | Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence | Incontinence, Urge 180 Days | 1.1 percentage of incontinence events |
Secondary
Length of Hospital Stay
Summarize length of hospital stay (in days) from admission through discharge
Time frame: The number of days from admission through discharge from the medical facility will be measured.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| GreenLight XPS Laser System | Length of Hospital Stay | 0.5 days |
Secondary
Number of Participants Stratified by Number of Fibers Used During Procedure
Summarize characteristics of the study procedure and immediate outcomes: number of fibers used
Time frame: Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GreenLight XPS Laser System | Number of Participants Stratified by Number of Fibers Used During Procedure | Number of Fibers Used: 1 | 873 participants |
| GreenLight XPS Laser System | Number of Participants Stratified by Number of Fibers Used During Procedure | Number of Fibers Used: 2 | 76 participants |
| GreenLight XPS Laser System | Number of Participants Stratified by Number of Fibers Used During Procedure | Number of Fibers Used: >=3 | 4 participants |
Secondary
Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure
* Emergency room visit for an adverse event related to the study device or procedure within 90 days of procedure * Hospital admission for an adverse event related to the study device or procedure within 90 days of procedure * Surgical intervention for an adverse event related to the study device or procedure within 90 days of procedure
Time frame: Up to 90 days post-procedure.
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported. Results presented are number of subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GreenLight XPS Laser System | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | Hospital Admission 90 Days | 19 Participants |
| GreenLight XPS Laser System | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | ER Visit 30 Days | 39 Participants |
| GreenLight XPS Laser System | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | ER Visit 90 Days | 43 Participants |
| GreenLight XPS Laser System | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | Hospital Admission 30 Days | 14 Participants |
| GreenLight XPS Laser System | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure | Surgical Re-treatment 90 Days | 4 Participants |
Secondary
Type of Hospital Stay
Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)
Time frame: Data will be collected during the time of their hospital stay from admission through discharge
Population: Data collected for this study was retrospective in nature and only data available in the medical records could be reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GreenLight XPS Laser System | Type of Hospital Stay | Admission Type: Outpatient | 674 participants |
| GreenLight XPS Laser System | Type of Hospital Stay | Admission Type: Outpatient overnight stay | 222 participants |
| GreenLight XPS Laser System | Type of Hospital Stay | Admission Type: inpatient | 58 participants |