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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GreenLight XPS | Experimental | Photoselective vaporization of the prostate using GreenLight XPS laser system. |
|
| Transurethral Resection of the Prostate | Active Comparator | Monopolar and bipolar Transuretheral resection of the prostate (TURP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoselective Vaporization of the Prostate | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Urinary Flow Rate (Qmax) | Qmax measured from a void of at least 150 ml in volume. | 6 months |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Bachman, Prof. Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Andrew Thomas, MBBCh, FRCS | Princess of Wales Hospital, Bridgend Mid Glamorgan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Schwestern Linz | Linz | Austria | ||||
| AZ Maria Middelares Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26283011 | Derived | Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15. | |
| 24331152 |
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Ten subjects were determined to be ineligible for the study procedure and were withdrawn before randomization (i.e., study procedure not performed).
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| ID | Title | Description |
|---|---|---|
| FG000 | GreenLight XPS | Photoselective vaporization of the prostate using GreenLight XPS Laser System. |
| FG001 | TURP | Monopolar and bipolar loop TURP Systems |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Transurethral Resection of the Prostate | Device | 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. |
|
| 180 days |
| Prostate Volume | Prostate volume measured via transrectal ultrasound | 6 months |
| 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. | 3 weeks post treatment |
| 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 | 3 weeks |
| 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). | Baseline and 24-months |
| 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). | Baseline, 12-months, and 24-months |
| 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. | 3-weeks, 3-months, 6-months, 12-months, and 24-months |
| 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 | 2 Years |
| Ghent |
| Belgium |
| Nouvel Hopital Civil de Strasbourg | Strasbourg | France |
| CHU Bretonneau | Tours | France |
| Campus Bejamin Franklin Hindenburgdamm | Berlin | Germany |
| UroForshungs GmbH, im St. hedwig Krankenhaus | Berlin | Germany |
| Krankenhaus Nordwest | Frankfurt | Germany |
| University Hospital of Heidelberg | Heidelberg | 69120 | Germany |
| Hospital University of Jena | Jena | Germany |
| Universitatsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Germany |
| Universitatsklinikum Leipzig | Leipzig | Germany |
| Universitatsklinikum Magdeburg | Magdeburg | Germany |
| Diakoniekrankenhaus Rotenburg (W.) gGmbH | Rotenburg (Wümme) | Germany |
| Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital | Rome | Italy |
| ZGT Almelo | Almelo | Netherlands |
| RadBound University Njmegen Medical Centre | Nijmegen | 6500 HB Nijmegen | Netherlands |
| Hospital Iniversitario Fundacion Alcorcon | Madrid | Spain |
| Hospital de Manacor | Manacor | Spain |
| University of Basel | Basel | Switzerland |
| Frimley Park Hospital | Frimley | Camberley Surrey | GU16 7UJ- UK | United Kingdom |
| Brighton and Sussex University Hospitals NHS Trust | Brighton | East Sussex | BN2 1EX UK | United Kingdom |
| Basingstoke and North Hampshire NHS Foundation Trust | Basingstoke | Hampshire | RG24 9NA, UK | United Kingdom |
| Princess of Wales Hospital | Mid Glamorgan | Wales UK | CF31 1RQ | United Kingdom |
| Mid Yorkshire NHS Trust Dewsbury & District Hospital | Dewsbury | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Kent and Canterbury Hospital | Kent | United Kingdom |
| Kings's College Hospital | London | SE5 9RS | United Kingdom |
| Whipps Cross University Hospital | London | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Derived |
| Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyere F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitan C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants who were treated |
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| 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) | 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). | 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). | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Maximum Urinary Flow Rate (Qmax) | Qmax measured from a void of at least 150 ml in volume. | 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). | Posted | Mean | Standard Deviation | ml/s | 6 months |
|
| |||||||||||||||||||||||||||||
| 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. | Posted | Number | percentage of patients complication free | 180 days |
|
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| Secondary | Prostate Volume | Prostate volume measured via transrectal ultrasound | Posted | Mean | Standard Deviation | ml | 6 months |
|
| ||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | score | 3 weeks post treatment |
|
| |||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Deviation | hours | 3 weeks |
|
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| 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). | Table reflects available data at specified time-points | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24-months |
|
| |||||||||||||||||||||||||||||
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 12-months, and 24-months |
| |||||||||||||||||||||||||||||||
| 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. | Descriptive statistics including frequency and percentages will be calculated. Results presented below are number of respondents who said Yes. | Posted | Count of Participants | Participants | No | 3-weeks, 3-months, 6-months, 12-months, and 24-months |
|
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| 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 | Posted | Count of Participants | Participants | No | 2 Years |
|
|
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.
Not provided
| 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 | Photoselective vaporization of the prostate using GreenLight XPS Laser System. | 24 | 136 | 68 | 136 | ||
| EG001 | TURP | Monopolar and bipolar Transuretheral resection of the prostate (TURP) | 25 | 133 | 57 | 133 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Renal and urinary disorders |
| |||
| Urinary Tract Infection | Renal and urinary disorders |
| |||
| Irritative symptoms/pain/discomfort | Renal and urinary disorders |
| |||
| Stricture | Renal and urinary disorders | meatal, urethral, bladder neck |
| ||
| Urinary Incontinence | Renal and urinary disorders |
| |||
| Urinary Retention | Renal and urinary disorders |
| |||
| Other | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Vascular disorders |
| |||
| Urinary Tract Infection | Renal and urinary disorders |
| |||
| Irritative Symptoms/Pain/Discomfort | Renal and urinary disorders |
| |||
| Stricture (meatal, urethral, bladder neck) | Renal and urinary disorders |
| |||
| Urinary Incontinence | Renal and urinary disorders |
| |||
| Urinary Retention | Renal and urinary disorders |
| |||
| Other | Renal and urinary disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Teresa Takle-Flach, Director, Clinical Operations | Boston Scientific Corporation | (952)930-6000 | teresa.takle-flach@bsci.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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Not provided
| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Spain |
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| Belgium |
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| Austria |
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| Germany |
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| Netherlands |
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| Italy |
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| Switzerland |
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| United Kingdom |
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| Counts |
|---|
| Participants |
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| OG001 | Transurethral Resection of the Prostate | Monopolar and bipolar Transuretheral resection of the prostate (TURP) Transurethral Resection of the Prostate: 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. |
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