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

NCT ID: NCT01218672

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GreenLight XPS

Photoselective vaporization of the prostate using GreenLight XPS laser system.

Group Type: EXPERIMENTAL

Photoselective Vaporization of the Prostate

Intervention Type: 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.

Transurethral Resection of the Prostate

Monopolar and bipolar Transuretheral resection of the prostate (TURP)

Group Type: ACTIVE_COMPARATOR

Transurethral Resection of the Prostate

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

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.

• 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Bachman, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Andrew Thomas, MBBCh, FRCS

Role: PRINCIPAL_INVESTIGATOR

Princess of Wales Hospital, Bridgend Mid Glamorgan

Locations

Krankenhaus der Barmherzigen Schwestern Linz

Linz, , Austria

AZ Maria Middelares Gent

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, , 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, , Netherlands

Hospital Iniversitario Fundacion Alcorcon

Madrid, , Spain

Hospital de Manacor

Manacor, , Spain

University of Basel

Basel, , Switzerland

Frimley Park Hospital

Frimley, Camberley Surrey, United Kingdom

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, United Kingdom

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, Hampshire, United Kingdom

Princess of Wales Hospital

Mid Glamorgan, Wales UK, United Kingdom

Mid Yorkshire NHS Trust Dewsbury & District Hospital

Dewsbury, , United Kingdom

Western General Hospital

Edinburgh, , United Kingdom

Kent and Canterbury Hospital

Kent, , United Kingdom

Kings's College Hospital

London, , United Kingdom

Whipps Cross University Hospital

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

Countries

Austria; Belgium; France; Germany; Italy; Netherlands; Spain; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26283011 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24331152 (View on PubMed)

Other Identifiers

PE1006

Identifier Type: -

Identifier Source: org_study_id