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A 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

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ClinicalTrials.gov Identifier: NCT01218672
Recruitment Status : Unknown
Verified October 2012 by American Medical Systems.
Recruitment status was:  Active, not recruiting
First Posted : October 11, 2010
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
American Medical Systems

Brief Summary:
The study will compare procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP). 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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: GreenLight XPS vs. TURP Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 (The Goliath Study)
Study Start Date : April 2011
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: GreenLight XPS
Photoselective vaporization of the prostate using GreenLight XPS laser system.
Device: 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.

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.


Active Comparator: TURP
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
Device: 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.

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.





Primary Outcome Measures :
  1. BPH symptoms compared to TURP symptoms a 6 months post procedure [ Time Frame: 6 months ]
    To demonstrate that BPH symptoms after PVP are not worse when compared to TURP at 6 months post procedure measured via international prostate symptom score (IPSS) for the treatment of BPH.


Secondary Outcome Measures :
  1. To compare the functional status of PVP and TURP via maximum urinary flow rate (Qmax) [ Time Frame: 6 months ]
    Maximum urinary flow rate (Qmax) measured at baseline and a the 6-month follow-up visits

  2. To compare the complication-free rate of PVP and TURP [ Time Frame: 6 months ]

    A that is subject free of device and procedure-related complications. A complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria:

    • Required a prolonged or secondary hospitalization
    • Required surgical or invasive intervention (eg, breaking of the skin) and excuding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia
    • Perforation of tissue or a physiologic structure

  3. To compare prostate volume post treatment for PVP and TURP [ Time Frame: 6 months ]
    Prostate volume (vis TRUS) taken at baseline and 6 month follow-up visit.

  4. To compare immediate post treatment outcomes of PVP and TURP [ Time Frame: 3 weeks ]
    SF-36 Acute form collected at 3-week visit (2 composite score and 6 subscores). Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time

  5. To compare health status of PVP and TURP [ Time Frame: 2 years ]
    The IPSS, BII, OABq, SF-36 Acute and EQ-5D instruments will be scored per instructions for each instrument as collected at baseline and follow-up visit case report forms.

  6. To compare tolerability of PVP and TURP [ Time Frame: 2 Years ]
    The IIEF and ICIQ-SF instruments will be scored per instructions for each instrument as collected at baseline and the follow-up visit case report forms.

  7. To compare subject satisfaction of PVP and TURP [ Time Frame: 2 Years ]
    Subject responses to satisfaction with treatment as collected on follow-up visits.

  8. To compare rate of retreatment of PVP and TURP [ Time Frame: 2 Years ]
    Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218672


Locations
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Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz, Austria
Belgium
AZ Maria Middelares Gent
Gent, Belgium
France
Nouvel Hopital Civil de Strasbourg
Strasbourg Cedex, France
CHU Bretonneau
Tours Cedex, France
Germany
Helmut Knispel
Berlin, Germany
Kurt Miller
Berlin, Germany
Krankenhaus Nordwest
Frankfurt, Germany
University Hospital of Heidelberg
Heidelberg, Germany, 69120
Hospital University of Jena
Jena, Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Universitatsklinikum Leipzig
Leipzig, Germany
Prof. Martin Schostak
Magdeburg, Germany
Diakoniekrankenhaus Rotenburg (W.) gGmbH
Rotenburg (Wumme), Germany
Italy
Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital
Rome, Italy
Netherlands
ZGT Almelo
Almelo, Netherlands
RadBound University Njmegen Medical Centre
Njmegen, Netherlands, 6500 HB Nijmegen
Spain
Carlos Capitan
Madrid, Spain
Hospital de Manacor
Manacor, Spain
Switzerland
University of Basel
Basel, Switzerland
United Kingdom
Frimley Park Hospital
Frimley, Camberley Surrey, United Kingdom, GU16 7UJ- UK
Brighton and Sussex University Hospitals NHS Trust
Brighton, East Sussex, United Kingdom, BN2 1EX UK
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom, RG24 9NA, UK
Princess of Wales Hospital
Mid Glamorgan, Wales UK, United Kingdom, CF31 1RQ
Nirjan Gogoi
Dewsbury, United Kingdom
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Nitin Shrotri
Kent, United Kingdom
Kings's College Hospital
London,, United Kingdom, SE5 9RS
Mr Stuart Graham
London, United Kingdom
Mr Andrew Thorpe
Newcastle, United Kingdom
Sponsors and Collaborators
American Medical Systems
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT01218672     History of Changes
Other Study ID Numbers: PE1006
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2012
Keywords provided by American Medical Systems:
BPH
Benign Prostatic Hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male