NCT01218672

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
9 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

September 3, 2020

Completed
Last Updated

September 3, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

October 8, 2010

Results QC Date

February 4, 2016

Last Update Submit

September 1, 2020

Conditions

Benign Prostatic Hyperplasia

Keywords

BPHBenign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Maximum Urinary Flow Rate (Qmax)

    6 months

  • Freedom From Complications

    180 days

  • Prostate Volume

    6 months

  • Post Treatment Outcomes of PVP and TURP

    3 weeks post treatment

  • Immediate Post Treatment Outcomes of PVP and TURP

    3 weeks

  • +4 more secondary outcomes

Study Arms (2)

GreenLight XPS

EXPERIMENTAL

Photoselective vaporization of the prostate using GreenLight XPS laser system.

Device: Photoselective Vaporization of the Prostate

Transurethral Resection of the Prostate

ACTIVE COMPARATOR

Monopolar and bipolar Transuretheral resection of the prostate (TURP)

Device: Transurethral Resection of the Prostate

Interventions

Photoselective Vaporization of the ProstateDEVICE

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.

GreenLight XPS
Transurethral Resection of the ProstateDEVICE

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.

Transurethral Resection of the Prostate

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Krankenhaus der Barmherzigen Schwestern Linz

Linz, Austria

Location

AZ Maria Middelares Gent

Ghent, Belgium

Location

Nouvel Hopital Civil de Strasbourg

Strasbourg, France

Location

CHU Bretonneau

Tours, France

Location

Campus Bejamin Franklin Hindenburgdamm

Berlin, Germany

Location

UroForshungs GmbH, im St. hedwig Krankenhaus

Berlin, Germany

Location

Krankenhaus Nordwest

Frankfurt, Germany

Location

University Hospital of Heidelberg

Heidelberg, 69120, Germany

Location

Hospital University of Jena

Jena, Germany

Location

Universitatsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

Location

Universitatsklinikum Leipzig

Leipzig, Germany

Location

Universitatsklinikum Magdeburg

Magdeburg, Germany

Location

Diakoniekrankenhaus Rotenburg (W.) gGmbH

Rotenburg (Wümme), Germany

Location

Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital

Rome, Italy

Location

ZGT Almelo

Almelo, Netherlands

Location

RadBound University Njmegen Medical Centre

Nijmegen, 6500 HB Nijmegen, Netherlands

Location

Hospital Iniversitario Fundacion Alcorcon

Madrid, Spain

Location

Hospital de Manacor

Manacor, Spain

Location

University of Basel

Basel, Switzerland

Location

Frimley Park Hospital

Frimley, Camberley Surrey, GU16 7UJ- UK, United Kingdom

Location

Brighton and Sussex University Hospitals NHS Trust

Brighton, East Sussex, BN2 1EX UK, United Kingdom

Location

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA, UK, United Kingdom

Location

Princess of Wales Hospital

Mid Glamorgan, Wales UK, CF31 1RQ, United Kingdom

Location

Mid Yorkshire NHS Trust Dewsbury & District Hospital

Dewsbury, United Kingdom

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Kent and Canterbury Hospital

Kent, United Kingdom

Location

Kings's College Hospital

London, SE5 9RS, United Kingdom

Location

Whipps Cross University Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 26283011DERIVED

  • 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.

    PMID: 24331152DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Teresa Takle-Flach, Director, Clinical Operations
Organization
Boston Scientific Corporation
teresa.takle-flach@bsci.com
(952)930-6000

Study Officials

  • Alexander Bachman, Prof. Dr. med.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Andrew Thomas, MBBCh, FRCS

    Princess of Wales Hospital, Bridgend Mid Glamorgan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 11, 2010

Study Start

April 1, 2011

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

September 3, 2020

Results First Posted

September 3, 2020

Record last verified: 2020-07

Locations

IT(1)AU(1)NL(2)GB(10)ES(2)DE(9)BE(1)FR(2)CH(1)