Clinical trial NCT01218672: Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System vs TURP for the Treatment of BPH
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Benign Prostatic Hyperplasia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-10-11
Enrollment: 291
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 6 months
Secondary outcomes:
measure: Maximum Urinary Flow Rate (Qmax)
timeFrame: 6 months
measure: Freedom From Complications
timeFrame: 180 days
measure: Prostate Volume
timeFrame: 6 months
measure: Post Treatment Outcomes of PVP and TURP
timeFrame: 3 weeks post treatment
measure: Immediate Post Treatment Outcomes of PVP and TURP
timeFrame: 3 weeks
measure: Health Status of PVP and TURP
timeFrame: Baseline and 24-months
measure: Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: Baseline, 12-months, and 24-months
measure: Subject Satisfaction of PVP and TURP
timeFrame: 3-weeks, 3-months, 6-months, 12-months, and 24-months
measure: Rate of Retreatment of PVP and TURP
timeFrame: 2 Years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent
city: Strasbourg Cedex
country: France
facility: Nouvel Hopital Civil de Strasbourg
city: Tours Cedex
country: France
facility: CHU Bretonneau
city: Berlin
country: Germany
facility: Campus Bejamin Franklin Hindenburgdamm
city: Berlin
country: Germany
facility: UroForshungs GmbH, im St. hedwig Krankenhaus
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Heidelberg
country: Germany
facility: University Hospital of Heidelberg
city: Jena
country: Germany
facility: Hospital University of Jena
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg
city: Rotenburg (Wumme)
country: Germany
facility: Diakoniekrankenhaus Rotenburg (W.) gGmbH
city: Rome
country: Italy
facility: Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital
city: Almelo
country: Netherlands
facility: ZGT Almelo
city: Nijmegen
country: Netherlands
facility: RadBound University Njmegen Medical Centre
city: Madrid
country: Spain
facility: Hospital Iniversitario Fundacion Alcorcon
city: Manacor
country: Spain
facility: Hospital de Manacor
city: Basel
country: Switzerland
facility: University of Basel
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
state: Camberley Surrey
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospitals NHS Trust
state: East Sussex
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire NHS Foundation Trust
state: Hampshire
city: Mid Glamorgan
country: United Kingdom
facility: Princess of Wales Hospital
state: Wales UK
city: Dewsbury
country: United Kingdom
facility: Mid Yorkshire NHS Trust Dewsbury & District Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Kent
country: United Kingdom
facility: Kent and Canterbury Hospital
city: London,
country: United Kingdom
facility: Kings's College Hospital
city: London
country: United Kingdom
facility: Whipps Cross University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Alexander Bachman, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess of Wales Hospital, Bridgend Mid Glamorgan
name: Andrew Thomas, MBBCh, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.