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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 8, 2010
First Posted Date  ICMJE October 11, 2010
Last Update Posted Date October 30, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
BPH symptoms versus TURP symptoms [ 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.
Change History Complete list of historical versions of study NCT01218672 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2011)
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • To compare subject satisfaction of PVP and TURP [ Time Frame: 2 Years ]
    Subject responses to satisfaction with treatment as collected on follow-up visits.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2010)
  • To compare the complication-free rate between PVP and TURP [ Time Frame: 2 years ]
    A subject that is free of device and procedure-related complications. A complication is defined as a device or procedure-related related adverse event meeting at least 1 of the following criteria:
    • required prolonged or secondary hospitalization
    • required surgical or invasive intervention (eg, breaking of skin) and excluding:
    • urinary catheterization for transient retention lasting less than 7 days
    • IV medications related to anesthesia
    • perforation of tissue or physiologic structure
  • To compare prostate volume post treatment for PVP and TURP [ Time Frame: 6 months ]
    Prostate volume (via TRUS or abdominal ultrasonography) as reported on the case report forms at baseline and 6-month follow-up visit
  • To compare functional status of PVP and TURP via maximum urinary flow rate (Qmax) [ Time Frame: 2 years ]
    Maximum urinary flow rate (aka Qmax, measured in ml/s) at baseline, 3, 6, 12, and 24-month follow-up visits. The proportion of subjects with a Qmax of 15ml/s or greater at 3, 6, 12, and 24-month follow-up visits. A measure of 15ml/s or greater is indicative of non-obstructed urinary flow.
  • 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
  • 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. For each instrument score/subscore, descriptive statistics including mean, standard deviation, median and range will summarize values for baseline and follow-up visits. Testing for differences between the PVP and TURP arms will be performed using Student t-tests or Wilcoxon Rank Sum Test when appropriate.
  • 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. For each instrument score/subscore, descriptive statistics including mean, standard deviation, median and range will summarize values for baseline, 6, 12, and 24-month visits. Testing for differences between the PVP and TURP arm will be performed using Student t-tests
  • To compare subject satisfaction of PVP and TURP [ Time Frame: 2 Years ]
    Subject responses to satisfaction with treatment as collected on follow-up visits. Descriptive statistics including frequency and percentages will be calculated. Proportions may be compared between PVP and TURP arms using Chi-square test with continuity correction.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Benign Prostatic Hyperplasia
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Active Comparator: GreenLight XPS
    Photoselective vaporization of the prostate using GreenLight XPS laser system.
    Intervention: Device: GreenLight XPS vs. TURP
  • Active Comparator: TURP
    Monopolar and bipolar Transuretheral resection of the prostate (TURP)
    Intervention: Device: GreenLight XPS vs. TURP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 13, 2011)
290
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2010)
252
Estimated Study Completion Date  ICMJE January 2015
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01218672
Other Study ID Numbers  ICMJE PE1006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party American Medical Systems
Study Sponsor  ICMJE American Medical Systems
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander Bachman, Prof. Dr. med. University Hospital, Basel, Switzerland
Principal Investigator: Andrew Thomas, MBBCh, FRCS Princess of Wales Hospital, Bridgend Mid Glamorgan
PRS Account American Medical Systems
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP