Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH

A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia

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).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Photoselective Vaporization of the Prostate; Device: Transurethral Resection of the Prostate

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Krankenhaus Der Barmherzigen Schwestern Linz
• Belgium
  • Gent, Belgium
    • Az Maria Middelares Gent
• France
  • Strasbourg Cedex, France
    • Nouvel Hôpital Civil de Strasbourg
  • Tours Cedex, France
    • CHU Bretonneau
• Germany
  • Berlin, Germany
    • Campus Bejamin Franklin Hindenburgdamm
  • Berlin, Germany
    • UroForshungs GmbH, im St. hedwig Krankenhaus
  • Frankfurt, Germany
    • Krankenhaus Nordwest
  • Heidelberg, Germany, 69120
    • University Hospital of Heidelberg
  • Jena, Germany
    • Hospital University of Jena
  • Kiel, Germany
    • Universitätsklinikum Schleswig-Holstein, Campus Kiel
  • Leipzig, Germany
    • Universitatsklinikum Leipzig
  • Magdeburg, Germany
    • Universitätsklinikum Magdeburg
  • Rotenburg (Wumme), Germany
    • Diakoniekrankenhaus Rotenburg (W.) gGmbH
• Italy
  • Rome, Italy
    • Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital
• Netherlands
  • Almelo, Netherlands
    • ZGT Almelo
  • Nijmegen, Netherlands, 6500 HB Nijmegen
    • RadBound University Njmegen Medical Centre
• Spain
  • Madrid, Spain
    • Hospital Iniversitario Fundacion Alcorcon
  • Manacor, Spain
    • Hospital de Manacor
• Switzerland
  • Basel, Switzerland
    • University of Basel
• United Kingdom
  • Dewsbury, United Kingdom
    • Mid Yorkshire NHS Trust Dewsbury & District Hospital
  • Edinburgh, United Kingdom, EH4 2XU
    • Western General Hospital
  • Kent, United Kingdom
    • Kent and Canterbury Hospital
  • London, United Kingdom
    • Whipps Cross University Hospital
  • London,, United Kingdom, SE5 9RS
    • Kings's College Hospital
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Camberley Surrey
    • Frimley, Camberley Surrey, United Kingdom, GU16 7UJ- UK
      • Frimley Park Hospital
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 1EX UK
      • Brighton and Sussex University Hospitals NHS Trust
  • Hampshire
    • Basingstoke, Hampshire, United Kingdom, RG24 9NA, UK
      • Basingstoke and North Hampshire NHS Foundation Trust
  • Wales UK
    • Mid Glamorgan, Wales UK, United Kingdom, CF31 1RQ
      • Princess of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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/exclusion criteria)
• Subject is classified as American Society of Anesthesiologists (ASA) I, II or III
• Subject has a serum creatinine that is within the normal range for the laboratory at the study center (or documentation of clinical insignificance in the subject's medical record by the investigator if outside the normal range) and measured less than or equal to 30 days prior to the date of surgery.

Exclusion criteria:

• Subject has a life expectancy of less than 2 years
• Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless preapproved by the sponsor
• Subject has an active infection (eg, urinary tract infection or prostatitis)
• Subject has a diagnosis of, or has received treatment for, chronic prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis)
• Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date
• Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within the 5 years prior to the informed consent date
• Subject has a diagnosis of lichen sclerosus
• Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson's disease, spinal cord injuries)
• Subject has a diagnosis of polyneuropathy (eg, diabetic)
• Subject has history of lower urinary tract surgery (eg, TURP, laser, urinary diversion, artificial urinary sphincter, penile prosthesis)
• Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use
• Subject has a history of intermittent self catheterization
• Subject has been catheterized or has a PVR >400mls in the 14 days prior to the surgical procedure
• Subject has current diagnosis of bladder stones
• Subject has diagnosis of prostate cancer
• Subject has a history of CIS, TaGII, TaGIII or any T1 stage bladder cancer
• Subject has damage to external urinary sphincter
• Subject has a medical contraindication for undergoing either TURP or PVP surgery (eg, infection, coagulopathy or significant cardiac or other medical risk factors for surgery)
• Subject has a disorder of the coagulation cascade (eg, hemophilia) or disorders that affect platelet count or function (eg, Von Willebrand's disease) that would put the subject at risk for intraoperative or postoperative bleeding
• Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 days) except for low dose aspirin (eg, less than or equal to 100mg)
• Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent
• Subject is immunocompromised (eg, organ transplant, leukemia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GreenLight XPS; Photoselective vaporization of the prostate using GreenLight XPS laser system.	Device: Photoselective 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.
ACTIVE_COMPARATOR: Transurethral Resection of the Prostate; Monopolar and bipolar Transuretheral resection of the prostate (TURP)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Alexander Bachman, Prof. Dr. med., University Hospital, Basel, Switzerland; Principal Investigator: Andrew Thomas, MBBCh, FRCS, Princess of Wales Hospital, Bridgend Mid Glamorgan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: October 8, 2010
• First Submitted That Met QC Criteria: October 8, 2010
• First Posted (ESTIMATE): October 11, 2010

Study Record Updates

• Last Update Posted (ACTUAL): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; BPH
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PE1006