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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GreenLight XPS Laser System | Treatment of BPH in men using the GreenLight XPS Laser System and the MoXy fiber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GreenLight XPS Laser System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-procedure |
| Occurrence of Adverse Events Related to the Study Treatment. | Treatment-related adverse events include:
The number of events as well as the number and percentage of subjects with the event will be calculated. | 365 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristics of the Study Procedure | Summary of the study procedure, including length of procedure and lasing time | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
| Characteristics of the Study Procedure and Immediate Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of males who have had the GreenLight XPS procedure with the MoXy fiber on or after 01-Aug-2010. The cohort will be selected from six pre-selected urology clinics in the US and one pre-selected urology clinic in Canada.
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| Name | Affiliation | Role |
|---|---|---|
| Mahmood A. Hai, M.D. | Affiliates Division, Comprehensive Urology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Camino Urology Medical Group, Inc. | Mountain View | California | 94040 | United States | ||
| Georgia Urology |
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| ID | Title | Description |
|---|---|---|
| FG000 | GreenLight XPS Laser System | Treatment of men with BPH using the GreenLight XPS Laser System and the MoXy fiber |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GreenLight XPS Laser System | Treatment of BPH in men using the GreenLight XPS Laser System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Count of Participants | Participants | No | 6 months post-procedure |
|
Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GreenLight XPS Laser System | Treatment of BPH in men using the GreenLight XPS Laser System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraoperative Bleeding | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Incontinence - De Novo Stress | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Olson, Clinical Project Manager | Boston Scientific Corporation | 9529306428 | laura.olson2@bsci.com |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ) |
| Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
| 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. | Baseline through six months post-procedure |
| 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) | Baseline through six months post-procedure. |
| 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. |
| 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. | 90 days, 180 days |
| 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. | Procedure through five years post-procedure. |
| Characteristics of the Study Procedure and Immediate Outcomes | Summarize characteristics of the study procedure and immediate outcomes: length of catheterization | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
| Length of Hospital Stay | Summarize length of hospital stay (in days) from admission through discharge | The number of days from admission through discharge from the medical facility will be measured. |
| Type of Hospital Stay | Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay) | Data will be collected during the time of their hospital stay from admission through discharge |
| Number of Participants Stratified by Number of Fibers Used During Procedure | Summarize characteristics of the study procedure and immediate outcomes: number of fibers used | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
| 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 | Baseline through six months post-procedure |
| Changes in Objective Measures of Urologic Function | Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume | Baseline through six months post-procedure. |
| 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 | From baseline through six months post-procedure. |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Affiliates Division, Comprehensive Urology | Westland | Michigan | 48186 | United States |
| Houston Metro Urology | Houston | Texas | 77027 | United States |
| Urology of Virginia, PLLC | Virginia Beach | Virginia | 23462 | United States |
| University of Montreal Hospital Center | Montreal | Quebec | Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Occurrence of Adverse Events Related to the Study Treatment. | Treatment-related adverse events include:
The number of events as well as the number and percentage of subjects with the event will be calculated. | Number of participants with a treatment-related adverse event. | Posted | Number | Treatment-related Events | 365 Days |
|
|
|
| Secondary | Characteristics of the Study Procedure | Summary of the study procedure, including length of procedure and lasing time | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Mean | Standard Deviation | minutes | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
|
|
|
| Secondary | Characteristics of the Study Procedure and Immediate Outcomes | Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ) | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Mean | Standard Deviation | kJ | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
|
|
|
| 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. | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline through six months post-procedure |
|
|
|
| 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) | 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). | Posted | Mean | Standard Deviation | ml/sec | Baseline through six months post-procedure. |
|
|
|
| Secondary | Number of Participants With ER Visits, Hospital Admissions, and Surgical Re-treatments for Treatment-related Adverse Events Up to 90 Days Post-Procedure |
| 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. | Posted | Number | Participants | Up to 90 days post-procedure. |
|
|
|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of incontinence events | 90 days, 180 days |
|
|
|
| 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. | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Count of Participants | Participants | Procedure through five years post-procedure. |
|
|
|
| Secondary | Characteristics of the Study Procedure and Immediate Outcomes | Summarize characteristics of the study procedure and immediate outcomes: length of catheterization | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Mean | Full Range | days | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
|
|
|
| Secondary | Length of Hospital Stay | Summarize length of hospital stay (in days) from admission through discharge | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Mean | Full Range | days | The number of days from admission through discharge from the medical facility will be measured. |
|
|
|
| Secondary | Type of Hospital Stay | Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay) | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Number | participants | Data will be collected during the time of their hospital stay from admission through discharge |
|
|
|
| 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 | Data collected for this study was retrospective in nature and only data available in the medical records could be reported. | Posted | Number | participants | Participants will be followed from admission through discharge from the medical facility, an expected average of 2 days. |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | ml | Baseline through six months post-procedure |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | grams | Baseline through six months post-procedure. |
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | ng/ml | From baseline through six months post-procedure. |
|
|
|
| 13 |
| 956 |
| 182 |
| 956 |
| Bladder Neck Obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria - Gross | Renal and urinary disorders | Non-systematic Assessment |
|
| Irritative Voiding Symptoms | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Clot Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Reobstruction Due to Prostate Regrowth | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Urinary Incontinence - De Novo Urge | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Erectile Dysfunction - De Novo | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder Neck Obstruction | Renal and urinary disorders | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Irritative Voiding Symptoms | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Frequency | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Urgency | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Urethral Injury | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary Incontinence - Worsening Urge | Renal and urinary disorders | Non-systematic Assessment |
|
| Erectile Dysfunction - Worsening | Renal and urinary disorders | Non-systematic Assessment |
|
| Bladder Spasms | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematospermia | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria - Gross | Renal and urinary disorders | Non-systematic Assessment |
|
| Prostatitis | Renal and urinary disorders | Non-systematic Assessment |
|
| Nocturia | Renal and urinary disorders | Non-systematic Assessment |
|
| Clot Retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Cardiac Arrhthmia | Cardiac disorders | Non-systematic Assessment |
|
| Other | General disorders | Non-systematic Assessment |
|
| Retrograde Ejaculation - De Novo | Renal and urinary disorders | Non-systematic Assessment |
|
| Urethral Stricture | Renal and urinary disorders | Non-systematic Assessment |
|
| Insufficient Tissue Removal | Renal and urinary disorders | Non-systematic Assessment |
|
| Malfunction of XPS Fiber | Renal and urinary disorders | Non-systematic Assessment |
|
| Reobstruction Due to Prostate Regrowth | Renal and urinary disorders | Non-systematic Assessment |
|
| Excessive Bleeding | Renal and urinary disorders | Non-systematic Assessment |
|
| Intraoperative Bleeding | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Perforation - Prostate | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal Failure / Insufficiency | Renal and urinary disorders | Non-systematic Assessment |
|
| Sloughing | Renal and urinary disorders | Non-systematic Assessment |
|
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| D052801 |
| Male Urogenital Diseases |
|
|
| Qmax Change from Baseline |
|
|
| Title | Measurements |
|---|---|
|
| Hospital Admission 90 Days |
|
| Surgical Re-treatment 90 Days |
|
|
| Incontinence, Stress 180 Days |
|
|
| Incontinence, Urge 180 Days |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| PVR Change from Baseline |
|
|
|
| Prostate Volume (g) Change from Baseline |
|
|
|
| PSA (ng/ml) Change from Baseline |
|
|