Trial Outcomes & Findings for GreenLight XPS Laser System Retrospective Chart Review (NCT NCT02139969)

Last Updated: 2020-11-09

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

956 participants

Primary outcome timeframe

6 months post-procedure

Results posted on

2020-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	GreenLight XPS Laser System Treatment of men with BPH using the GreenLight XPS Laser System and the MoXy fiber
Overall Study STARTED	956
Overall Study COMPLETED	956
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GreenLight XPS Laser System Retrospective Chart Review

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Age, Continuous	68.6 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	956 Participants n=5 Participants
Region of Enrollment Canada	199 participants n=5 Participants
Region of Enrollment United States	757 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=572 Participants Treatment of BPH in men using the GreenLight XPS Laser System
International Prostate Symptom Score (IPSS) Score of <=8	437 Participants
International Prostate Symptom Score (IPSS) Score of 9-21	118 Participants
International Prostate Symptom Score (IPSS) Score of >21	17 Participants

PRIMARY outcome

Timeframe: 365 Days

Population: Number of participants with a treatment-related adverse event.

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.

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=191 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Occurrence of Adverse Events Related to the Study Treatment.	249 Treatment-related Events

SECONDARY outcome

Timeframe: 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.

Summary of the study procedure, including length of procedure and lasing time

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Characteristics of the Study Procedure Length of Procedure (minutes)	57.1 minutes Standard Deviation 28.6
Characteristics of the Study Procedure Lasing Time (minutes)	33.2 minutes Standard Deviation 18.9

SECONDARY outcome

Timeframe: 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.

Summary of characteristics of the study procedure and immediate outcomes: total energy used (kJ)

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=954 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Characteristics of the Study Procedure and Immediate Outcomes	275.8 kJ Standard Deviation 180.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the 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 outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the 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
Assess Changes in Objective Measures of Urologic Function. Qmax 6 months (ml/sec)	18.0 ml/sec Standard Deviation 8.9
Assess Changes in Objective Measures of Urologic Function. Qmax Change from Baseline	10.9 ml/sec Standard Deviation 10.0

SECONDARY outcome

Timeframe: 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.

* 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

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the 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
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
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
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
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the 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 Interval 0.4 to 1.7
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence Incontinence, Urge 90 Days	0.9 percentage of incontinence events Interval 0.4 to 1.7
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence Incontinence, Stress 180 Days	1.3 percentage of incontinence events Interval 0.6 to 2.3
Evaluate the Percentage of Participants Experience Ongoing Treatment-related Urinary Incontinence Incontinence, Urge 180 Days	1.1 percentage of incontinence events Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: 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.

Number of surgical re-treatment for BPH as a result of prostate tissue regrowth or insufficient prostatic tissue removal.

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=955 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. Reobstruction due to prostate regrowth	4 Participants
Assess the Occurrence of Surgical Retreatment for BPH in GreenLight XPS Patients. Insufficient tissue removal	3 Participants

SECONDARY outcome

Timeframe: 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.

Summarize characteristics of the study procedure and immediate outcomes: length of catheterization

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=709 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Characteristics of the Study Procedure and Immediate Outcomes	1.2 days Interval 0.1 to 14.0

SECONDARY outcome

Timeframe: 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.

Summarize length of hospital stay (in days) from admission through discharge

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=817 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Length of Hospital Stay	0.5 days Interval 0.1 to 6.1

SECONDARY outcome

Timeframe: 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.

Summarize characteristics of the type of hospital stay (in-patient vs out-patient with an overnight stay)

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=954 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Type of Hospital Stay Admission Type: Outpatient	674 participants
Type of Hospital Stay Admission Type: Outpatient overnight stay	222 participants
Type of Hospital Stay Admission Type: inpatient	58 participants

SECONDARY outcome

Timeframe: 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.

Summarize characteristics of the study procedure and immediate outcomes: number of fibers used

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=953 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Number of Participants Stratified by Number of Fibers Used During Procedure Number of Fibers Used: 1	873 participants
Number of Participants Stratified by Number of Fibers Used During Procedure Number of Fibers Used: 2	76 participants
Number of Participants Stratified by Number of Fibers Used During Procedure Number of Fibers Used: >=3	4 participants

SECONDARY outcome

Timeframe: Baseline through six months post-procedure

Changes in objective measures of urologic function from baseline through six months post-procedure using post void residual

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Assess Changes in Objective Measures of Urologic Function PVR Baseline (ml)	204.3 ml Standard Deviation 221.2
Assess Changes in Objective Measures of Urologic Function PVR 6 Months (ml)	46.1 ml Standard Deviation 95.2
Assess Changes in Objective Measures of Urologic Function PVR Change from Baseline	-172 ml Standard Deviation 215.4

SECONDARY outcome

Timeframe: Baseline through six months post-procedure.

Changes in objective measures of urologic function from baseline through six months post-procedure using prostate volume

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the GreenLight XPS Laser System
Changes in Objective Measures of Urologic Function Prostate Volume (g) Baseline	76.0 grams Standard Deviation 49.0
Changes in Objective Measures of Urologic Function Prostate Volume (g) 6 Months	44.0 grams Standard Deviation 36.2
Changes in Objective Measures of Urologic Function Prostate Volume (g) Change from Baseline	-31.8 grams Standard Deviation 38.3

SECONDARY outcome

Timeframe: From baseline through six months post-procedure.

Changes in objective measures of urologic function from baseline through six months post-procedure using prostate specific antigen

Outcome measures

Outcome measures
Measure	GreenLight XPS Laser System n=956 Participants Treatment of BPH in men using the 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
Assess Changes in Objective Measures of Urologic Function. PSA (ng/ml) Baseline	4.9 ng/ml Standard Deviation 7.8
Assess Changes in Objective Measures of Urologic Function. PSA (ng/ml) Change from Baseline	-2.0 ng/ml Standard Deviation 7.1

Adverse Events

GreenLight XPS Laser System

Serious events: 13 serious events

Other events: 182 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GreenLight XPS Laser System n=956 participants at risk Treatment of BPH in men using the GreenLight XPS Laser System
Renal and urinary disorders Intraoperative Bleeding	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Bladder Neck Obstruction	0.42% 4/956 • Number of events 4 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Hematuria - Gross	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Irritative Voiding Symptoms	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Retention	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Clot Retention	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Reobstruction Due to Prostate Regrowth	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Tract Infection	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
General disorders Other	0.10% 1/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.

Other adverse events

Other adverse events
Measure	GreenLight XPS Laser System n=956 participants at risk Treatment of BPH in men using the GreenLight XPS Laser System
Renal and urinary disorders Urinary Incontinence - De Novo Stress	1.4% 13/956 • Number of events 13 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Incontinence - De Novo Urge	1.4% 13/956 • Number of events 13 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Tract Infection	3.0% 29/956 • Number of events 29 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Erectile Dysfunction - De Novo	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Bladder Neck Obstruction	1.0% 10/956 • Number of events 10 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Dysuria	1.7% 16/956 • Number of events 16 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Irritative Voiding Symptoms	1.4% 13/956 • Number of events 13 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Frequency	0.94% 9/956 • Number of events 9 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Retention	4.1% 39/956 • Number of events 39 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Urgency	2.0% 19/956 • Number of events 19 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Bladder Injury	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urethral Injury	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urinary Incontinence - Worsening Urge	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Erectile Dysfunction - Worsening	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Bladder Spasms	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Hematospermia	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Hematuria - Gross	0.84% 8/956 • Number of events 8 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Prostatitis	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Nocturia	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Clot Retention	0.94% 9/956 • Number of events 9 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
General disorders Fever	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Cardiac disorders Cardiac Arrhthmia	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
General disorders Other	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Retrograde Ejaculation - De Novo	1.9% 18/956 • Number of events 18 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Urethral Stricture	0.63% 6/956 • Number of events 6 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Insufficient Tissue Removal	0.31% 3/956 • Number of events 3 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Malfunction of XPS Fiber	0.31% 3/956 • Number of events 3 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Reobstruction Due to Prostate Regrowth	0.31% 3/956 • Number of events 3 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Excessive Bleeding	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Intraoperative Bleeding	0.21% 2/956 • Number of events 2 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Hematuria	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Perforation - Prostate	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Renal Failure / Insufficiency	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.
Renal and urinary disorders Sloughing	0.10% 1/956 • Number of events 1 • Any device or treatment related adverse event was collected during the retrospective chart review, up to five years post-procedure for each participant.

Additional Information

Laura Olson, Clinical Project Manager

Boston Scientific Corporation

Phone: 9529306428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place