Benign Prostatic Hyperplasia
Conditions
Keywords
BPH, Benign Prostatic Hyperplasia
Brief summary
The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).
Detailed description
The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH). The purpose of the study is to demonstrate that PVP is not inferior to TURP.
Interventions
DEVICEPhotoselective Vaporization of the Prostate
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. GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator.
Monopolar and bipolar loop TURP Systems 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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent and agrees to attend all study visits * Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction * Subject is willing to be randomized * Subject is able to complete self-administered questionnaires * Clinical investigator has documented in the subject's medical record that in his/her judgment the subject is a surgical candidate for either the PVP or the TURP procedure and may be randomized into either arm * Subject is 40 to 80 years of age * Subject has an IPSS score greater than or equal to 12 measured at the baseline visit * Subject has medical record documentation of a maximum urinary flow rate (Qmax) less than 15ml/s (If uroflow testing documentation is available within 90 days prior to the informed consent date, and the sample is greater than or equal to 150ml, and the Qmax is less than 15ml/s it may be used for the inclusion/
Exclusion criteria
) * Subject has medical record documentation of a prostate volume of less than or equal to 100g by transrectal ultrasound (TRUS) (If TRUS testing documentation is available from less than 180 days prior to the informed consent date and the prostate volume is less than or equal to 100g, it may be used for the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | 6 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Complications | 180 days | A 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. |
| Prostate Volume | 6 months | Prostate volume measured via transrectal ultrasound |
| Post Treatment Outcomes of PVP and TURP | 3 weeks post treatment | 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. |
| Immediate Post Treatment Outcomes of PVP and TURP | 3 weeks | Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time |
| Maximum Urinary Flow Rate (Qmax) | 6 months | Qmax measured from a void of at least 150 ml in volume. |
| 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, 12-months, and 24-months | The 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). |
| Subject Satisfaction of PVP and TURP | 3-weeks, 3-months, 6-months, 12-months, and 24-months | 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. |
| Rate of Retreatment of PVP and TURP | 2 Years | Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required |
| Health Status of PVP and TURP | Baseline and 24-months | 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). |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
Ten subjects were determined to be ineligible for the study procedure and were withdrawn before randomization (i.e., study procedure not performed).
Participants by arm
| Arm | Count |
|---|---|
| GreenLight XPS 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. | 136 |
| TURP 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. | 133 |
| Total | 269 |
Baseline characteristics
| Characteristic | TURP | GreenLight XPS | Total |
|---|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 6.6 | 67.2 years STANDARD_DEVIATION 6.8 | 67.0 years STANDARD_DEVIATION 6.6 |
| Region of Enrollment Austria | 4 participants who were treated | 4 participants who were treated | 8 participants who were treated |
| Region of Enrollment Belgium | 5 participants who were treated | 5 participants who were treated | 10 participants who were treated |
| Region of Enrollment France | 7 participants who were treated | 8 participants who were treated | 15 participants who were treated |
| Region of Enrollment Germany | 35 participants who were treated | 28 participants who were treated | 63 participants who were treated |
| Region of Enrollment Italy | 10 participants who were treated | 12 participants who were treated | 22 participants who were treated |
| Region of Enrollment Netherlands | 12 participants who were treated | 13 participants who were treated | 25 participants who were treated |
| Region of Enrollment Spain | 8 participants who were treated | 8 participants who were treated | 16 participants who were treated |
| Region of Enrollment Switzerland | 12 participants who were treated | 10 participants who were treated | 22 participants who were treated |
| Region of Enrollment United Kingdom | 40 participants who were treated | 48 participants who were treated | 88 participants who were treated |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 133 Participants | 136 Participants | 269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 68 / 136 | 57 / 133 |
| serious Total, serious adverse events | 24 / 136 | 25 / 133 |
Outcome results
Primary
International Prostate Symptom Score (IPSS)
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).
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS | International Prostate Symptom Score (IPSS) | 6.8 units on a scale | Standard Deviation 5.2 |
| TURP | International Prostate Symptom Score (IPSS) | 5.6 units on a scale | Standard Deviation 4.9 |
Secondary
Freedom From Complications
A 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.
Time frame: 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GreenLight XPS | Freedom From Complications | 87.3 percentage of patients complication free |
| TURP | Freedom From Complications | 83.3 percentage of patients complication free |
Secondary
Health Status of PVP and TURP
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).
Time frame: Baseline and 24-months
Population: Table reflects available data at specified time-points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS | Health Status of PVP and TURP | Baseline IPSS | 21.2 units on a scale | Standard Deviation 5.9 |
| GreenLight XPS | Health Status of PVP and TURP | Baseline OABq | 44.2 units on a scale | Standard Deviation 20.5 |
| GreenLight XPS | Health Status of PVP and TURP | Baseline SF-36 Health Summary | 52.2 units on a scale | Standard Deviation 7.8 |
| GreenLight XPS | Health Status of PVP and TURP | Baseline EQ5D | 0.843 units on a scale | Standard Deviation 0.193 |
| GreenLight XPS | Health Status of PVP and TURP | 24-Month IPSS | 6.9 units on a scale | Standard Deviation 6 |
| GreenLight XPS | Health Status of PVP and TURP | 24-Month OABq | 15.3 units on a scale | Standard Deviation 16.7 |
| GreenLight XPS | Health Status of PVP and TURP | 24-Month SF-36 Health Summary | 52.5 units on a scale | Standard Deviation 8.1 |
| GreenLight XPS | Health Status of PVP and TURP | 24-Month EQ5D | 0.875 units on a scale | Standard Deviation 0.194 |
| TURP | Health Status of PVP and TURP | 24-Month EQ5D | 0.857 units on a scale | Standard Deviation 0.21 |
| TURP | Health Status of PVP and TURP | Baseline IPSS | 21.7 units on a scale | Standard Deviation 6.4 |
| TURP | Health Status of PVP and TURP | 24-Month IPSS | 5.9 units on a scale | Standard Deviation 6.1 |
| TURP | Health Status of PVP and TURP | Baseline OABq | 42.9 units on a scale | Standard Deviation 20.8 |
| TURP | Health Status of PVP and TURP | 24-Month SF-36 Health Summary | 53.2 units on a scale | Standard Deviation 8.5 |
| TURP | Health Status of PVP and TURP | Baseline SF-36 Health Summary | 51.9 units on a scale | Standard Deviation 7.1 |
| TURP | Health Status of PVP and TURP | 24-Month OABq | 11.9 units on a scale | Standard Deviation 13.7 |
| TURP | Health Status of PVP and TURP | Baseline EQ5D | 0.823 units on a scale | Standard Deviation 0.219 |
Secondary
Immediate Post Treatment Outcomes of PVP and TURP
Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time
Time frame: 3 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS | Immediate Post Treatment Outcomes of PVP and TURP | 65.5 hours | Standard Deviation 63.3 |
| TURP | Immediate Post Treatment Outcomes of PVP and TURP | 97.8 hours | Standard Deviation 63.4 |
Secondary
Maximum Urinary Flow Rate (Qmax)
Qmax measured from a void of at least 150 ml in volume.
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS | Maximum Urinary Flow Rate (Qmax) | 23.3 ml/s | Standard Deviation 10.1 |
| TURP | Maximum Urinary Flow Rate (Qmax) | 24.3 ml/s | Standard Deviation 11.4 |
Secondary
Post Treatment Outcomes of PVP and 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.
Time frame: 3 weeks post treatment
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS | Post Treatment Outcomes of PVP and TURP | SF36 - PCS | 50.3 score | Standard Deviation 8.1 |
| GreenLight XPS | Post Treatment Outcomes of PVP and TURP | SF36 - MHS | 50.0 score | Standard Deviation 9.7 |
| GreenLight XPS | Post Treatment Outcomes of PVP and TURP | SF36 Utility Index | 0.7 score | Standard Deviation 0.1 |
| TURP | Post Treatment Outcomes of PVP and TURP | SF36 - PCS | 50.5 score | Standard Deviation 7.3 |
| TURP | Post Treatment Outcomes of PVP and TURP | SF36 - MHS | 50.0 score | Standard Deviation 10.9 |
| TURP | Post Treatment Outcomes of PVP and TURP | SF36 Utility Index | 0.7 score | Standard Deviation 0.1 |
Secondary
Prostate Volume
Prostate volume measured via transrectal ultrasound
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GreenLight XPS | Prostate Volume | 23.0 ml | Standard Deviation 11.7 |
| TURP | Prostate Volume | 20.5 ml | Standard Deviation 11.7 |
Secondary
Rate of Retreatment of PVP and TURP
Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required
Time frame: 2 Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GreenLight XPS | Rate of Retreatment of PVP and TURP | Months 0-6 | 4 Participants |
| GreenLight XPS | Rate of Retreatment of PVP and TURP | Months 7-12 | 6 Participants |
| GreenLight XPS | Rate of Retreatment of PVP and TURP | Months 13-24 | 4 Participants |
| TURP | Rate of Retreatment of PVP and TURP | Months 0-6 | 7 Participants |
| TURP | Rate of Retreatment of PVP and TURP | Months 7-12 | 2 Participants |
| TURP | Rate of Retreatment of PVP and TURP | Months 13-24 | 1 Participants |
Secondary
Subject Satisfaction of PVP and TURP
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.
Time frame: 3-weeks, 3-months, 6-months, 12-months, and 24-months
Population: Descriptive statistics including frequency and percentages will be calculated. Results presented below are number of respondents who said Yes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GreenLight XPS | Subject Satisfaction of PVP and TURP | 116 Participants |
| TURP | Subject Satisfaction of PVP and TURP | 107 Participants |
Secondary
Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
The 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).
Time frame: Baseline, 12-months, and 24-months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GreenLight XPS | 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 |
| GreenLight XPS | 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 |
| GreenLight XPS | 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 |
| GreenLight XPS | 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 |
| TURP | 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 | 2.0 units on a scale | Standard Deviation 3.3 |
| TURP | 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 | 13.7 units on a scale | Standard Deviation 7.5 |
| TURP | 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 | 13.9 units on a scale | Standard Deviation 8.2 |
| TURP | 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 | 4.4 units on a scale | Standard Deviation 4.6 |