Trial Outcomes & Findings for Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH (NCT NCT01218672)
NCT ID: NCT01218672
Last Updated: 2020-09-03
Results Overview
The IPSS is a patient-administered 7-question instrument used to classify severity of benign prostatic hyperplasia symptoms (BPH). Total scores can range from 0 to 35 (asymptomatic to very symptomatic).
COMPLETED
NA
291 participants
6 months
2020-09-03
Participant Flow
Ten subjects were determined to be ineligible for the study procedure and were withdrawn before randomization (i.e., study procedure not performed).
Participant milestones
| Measure |
GreenLight XPS
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
142
|
|
Overall Study
Treated
|
136
|
133
|
|
Overall Study
COMPLETED
|
128
|
121
|
|
Overall Study
NOT COMPLETED
|
11
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH
Baseline characteristics by cohort
| Measure |
GreenLight XPS
n=136 Participants
Photoselective vaporization of the prostate using GreenLight XPS laser system.
GreenLight XPS vs. TURP: GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.
|
TURP
n=133 Participants
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 6.8 • n=99 Participants
|
66.7 years
STANDARD_DEVIATION 6.6 • n=107 Participants
|
67.0 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=99 Participants
|
133 Participants
n=107 Participants
|
269 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
8 participants who were treated
n=99 Participants
|
7 participants who were treated
n=107 Participants
|
15 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Spain
|
8 participants who were treated
n=99 Participants
|
8 participants who were treated
n=107 Participants
|
16 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Belgium
|
5 participants who were treated
n=99 Participants
|
5 participants who were treated
n=107 Participants
|
10 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Austria
|
4 participants who were treated
n=99 Participants
|
4 participants who were treated
n=107 Participants
|
8 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Germany
|
28 participants who were treated
n=99 Participants
|
35 participants who were treated
n=107 Participants
|
63 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants who were treated
n=99 Participants
|
12 participants who were treated
n=107 Participants
|
25 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Italy
|
12 participants who were treated
n=99 Participants
|
10 participants who were treated
n=107 Participants
|
22 participants who were treated
n=206 Participants
|
|
Region of Enrollment
Switzerland
|
10 participants who were treated
n=99 Participants
|
12 participants who were treated
n=107 Participants
|
22 participants who were treated
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
48 participants who were treated
n=99 Participants
|
40 participants who were treated
n=107 Participants
|
88 participants who were treated
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis includes all subjects who received a study treatment and for whom the outcome measure is available. Subjects were analyzed according to treatment received (as-treated analysis).
The IPSS is a patient-administered 7-question instrument used to classify severity of benign prostatic hyperplasia symptoms (BPH). Total scores can range from 0 to 35 (asymptomatic to very symptomatic).
Outcome measures
| Measure |
GreenLight XPS
n=134 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=131 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
International Prostate Symptom Score (IPSS)
|
6.8 units on a scale
Standard Deviation 5.2
|
5.6 units on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis includes all subjects who received a study treatment and for whom the outcome measure is available. Subjects were analyzed according to treatment received (as-treated analysis).
Qmax measured from a void of at least 150 ml in volume.
Outcome measures
| Measure |
GreenLight XPS
n=116 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=117 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Maximum Urinary Flow Rate (Qmax)
|
23.3 ml/s
Standard Deviation 10.1
|
24.3 ml/s
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 180 daysA complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria: Perforation of tissue or a physiologic structure; Required a prolonged or secondary hospitalization; Required surgical or invasive intervention (e.g., breaking of the skin) and excluding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia.
Outcome measures
| Measure |
GreenLight XPS
n=134 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=132 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Freedom From Complications
|
87.3 percentage of patients complication free
|
83.3 percentage of patients complication free
|
SECONDARY outcome
Timeframe: 6 monthsProstate volume measured via transrectal ultrasound
Outcome measures
| Measure |
GreenLight XPS
n=132 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=127 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Prostate Volume
|
23.0 ml
Standard Deviation 11.7
|
20.5 ml
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: 3 weeks post treatmentPopulation: A total of 136 subjects underwent GL-XPS and 133 subjects underwent TURP procedures. The SF36 questionnaire is comprised of three sections; available data is: SF36 (PCS): 133 GL-XPS, 129 TURP; SF36 (MHS): 134 GL-XPS, 130 TURP; SF36 Utility Index: 125 GL-XPS, 121 TURP.
Short Form Health Survey (SF-36 Acute) collected at 3-week visit. The SF-36 is a multi-purpose, short-form, health survey of functional health and well-being scores in a three-section format: Utility Index (score = 0-1 with higher score being better); Physical Component Summary (PCS) comprising of physical functioning, role-physical, bodily pain, and overall general health; Mental Component Summary (MCS) comprising of vitality, social functioning, role-emotional, and mental health. Each component in the PCS and MCS sections have a score of 1-100 with the higher score being better. The acute version uses a 1-week recall period.
Outcome measures
| Measure |
GreenLight XPS
n=136 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Post Treatment Outcomes of PVP and TURP
SF36 - PCS
|
50.3 score
Standard Deviation 8.1
|
50.5 score
Standard Deviation 7.3
|
|
Post Treatment Outcomes of PVP and TURP
SF36 - MHS
|
50.0 score
Standard Deviation 9.7
|
50.0 score
Standard Deviation 10.9
|
|
Post Treatment Outcomes of PVP and TURP
SF36 Utility Index
|
0.7 score
Standard Deviation 0.1
|
0.7 score
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: A total of 136 subjects underwent GL-XPS and 133 subjects underwent TURP procedures. Length of Stay data available for 134 GL-XPS and 132 TURP subjects.
Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
Outcome measures
| Measure |
GreenLight XPS
n=134 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=132 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Immediate Post Treatment Outcomes of PVP and TURP
|
65.5 hours
Standard Deviation 63.3
|
97.8 hours
Standard Deviation 63.4
|
SECONDARY outcome
Timeframe: Baseline and 24-monthsPopulation: Table reflects available data at specified time-points
The IPSS, OABq, SF-36 Health Summary and EQ-5D instruments will be scored. IPSS classifies voiding symptoms with scores from 0-35 (asymptomatic to very symptomatic). The OABq captures overactive bladder symptom bother with scores from 0-100 (lower score is better). The SF-36 is a health survey with scores from 1-100 (higher score is better). EQ-5D assesses health status across a range of conditions and treatments with a score of 0-1 (higher score is better).
Outcome measures
| Measure |
GreenLight XPS
n=136 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Health Status of PVP and TURP
24-Month OABq
|
15.3 units on a scale
Standard Deviation 16.7
|
11.9 units on a scale
Standard Deviation 13.7
|
|
Health Status of PVP and TURP
Baseline IPSS
|
21.2 units on a scale
Standard Deviation 5.9
|
21.7 units on a scale
Standard Deviation 6.4
|
|
Health Status of PVP and TURP
Baseline OABq
|
44.2 units on a scale
Standard Deviation 20.5
|
42.9 units on a scale
Standard Deviation 20.8
|
|
Health Status of PVP and TURP
Baseline SF-36 Health Summary
|
52.2 units on a scale
Standard Deviation 7.8
|
51.9 units on a scale
Standard Deviation 7.1
|
|
Health Status of PVP and TURP
Baseline EQ5D
|
0.843 units on a scale
Standard Deviation 0.193
|
0.823 units on a scale
Standard Deviation 0.219
|
|
Health Status of PVP and TURP
24-Month IPSS
|
6.9 units on a scale
Standard Deviation 6.0
|
5.9 units on a scale
Standard Deviation 6.1
|
|
Health Status of PVP and TURP
24-Month SF-36 Health Summary
|
52.5 units on a scale
Standard Deviation 8.1
|
53.2 units on a scale
Standard Deviation 8.5
|
|
Health Status of PVP and TURP
24-Month EQ5D
|
0.875 units on a scale
Standard Deviation 0.194
|
0.857 units on a scale
Standard Deviation 0.210
|
SECONDARY outcome
Timeframe: Baseline, 12-months, and 24-monthsThe International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) instruments will be collected at baseline and the follow-up visits. The IIEF-5 is a self-administered 5 question instrument that assesses the relevant domains of male sexual function such as erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction with a total possible score of 5-25 (higher score is better). The ICIQ-SFis a self-administered 4-question tool designed for the assessment and quantification of incontinence and its impact on quality of life during the previous 4 weeks with a total score of 0-21 (higher score is worse).
Outcome measures
| Measure |
GreenLight XPS
n=136 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Baseline IIEF-5
|
13.2 units on a scale
Standard Deviation 7.6
|
13.7 units on a scale
Standard Deviation 7.5
|
|
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
Baseline ICIQ-UI SF
|
3.9 units on a scale
Standard Deviation 4.7
|
4.4 units on a scale
Standard Deviation 4.6
|
|
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
24-Months IIEF-5
|
12.9 units on a scale
Standard Deviation 7.5
|
13.9 units on a scale
Standard Deviation 8.2
|
|
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
24-Months ICIQ-UI SF
|
2.8 units on a scale
Standard Deviation 4.1
|
2.0 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 3-weeks, 3-months, 6-months, 12-months, and 24-monthsPopulation: Descriptive statistics including frequency and percentages will be calculated. Results presented below are number of respondents who said Yes.
Subject responses to satisfaction with treatment as collected on follow-up visits. Data presented below indicates responses from subjects that would go through study treatment again at each of the defined follow-up visits.
Outcome measures
| Measure |
GreenLight XPS
n=125 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=120 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Subject Satisfaction of PVP and TURP
|
116 Participants
|
107 Participants
|
SECONDARY outcome
Timeframe: 2 YearsSubject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required
Outcome measures
| Measure |
GreenLight XPS
n=136 Participants
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 Participants
Monopolar and bipolar loop TURP Systems
|
|---|---|---|
|
Rate of Retreatment of PVP and TURP
Months 0-6
|
4 Participants
|
7 Participants
|
|
Rate of Retreatment of PVP and TURP
Months 7-12
|
6 Participants
|
2 Participants
|
|
Rate of Retreatment of PVP and TURP
Months 13-24
|
4 Participants
|
1 Participants
|
Adverse Events
GreenLight XPS
TURP
Serious adverse events
| Measure |
GreenLight XPS
n=136 participants at risk
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 participants at risk
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
|
|---|---|---|
|
Renal and urinary disorders
Bleeding
|
2.2%
3/136 • Number of events 3 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
6.0%
8/133 • Number of events 9 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
2.2%
3/136 • Number of events 3 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
1.5%
2/133 • Number of events 2 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Irritative symptoms/pain/discomfort
|
0.74%
1/136 • Number of events 1 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
0.00%
0/133 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Stricture
|
5.9%
8/136 • Number of events 8 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
5.3%
7/133 • Number of events 7 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Incontinence
|
4.4%
6/136 • Number of events 7 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
1.5%
2/133 • Number of events 2 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Retention
|
3.7%
5/136 • Number of events 5 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
4.5%
6/133 • Number of events 6 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Other
|
0.00%
0/136 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
0.75%
1/133 • Number of events 1 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
Other adverse events
| Measure |
GreenLight XPS
n=136 participants at risk
Photoselective vaporization of the prostate using GreenLight XPS Laser System.
|
TURP
n=133 participants at risk
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
|
|---|---|---|
|
Vascular disorders
Bleeding
|
9.6%
13/136 • Number of events 13 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
9.8%
13/133 • Number of events 13 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
18.4%
25/136 • Number of events 26 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
9.0%
12/133 • Number of events 14 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Irritative Symptoms/Pain/Discomfort
|
22.1%
30/136 • Number of events 33 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
22.6%
30/133 • Number of events 30 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Stricture (meatal, urethral, bladder neck)
|
0.74%
1/136 • Number of events 1 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
1.5%
2/133 • Number of events 2 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.4%
10/136 • Number of events 10 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
3.0%
4/133 • Number of events 4 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Urinary Retention
|
9.6%
13/136 • Number of events 13 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
6.8%
9/133 • Number of events 9 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
|
Renal and urinary disorders
Other
|
5.9%
8/136 • Number of events 8 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
6.0%
8/133 • Number of events 8 • From the date of the informed consent until the subject exits the study. (Mean follow-up was 23.3 months)
Adverse events determined as "Other" were not further defined during analysis.
|
Additional Information
Teresa Takle-Flach, Director, Clinical Operations
Boston Scientific Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place