Overview

This trial is active, not recruiting.

Condition benign prostatic hyperplasia
Treatment greenlight xps vs. turp
Phase phase 4
Sponsor American Medical Systems
Start date April 2011
End date October 2014
Trial size 290 participants
Trial identifier NCT01218672, PE1006

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Photoselective vaporization of the prostate using GreenLight XPS laser system.
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)
Monopolar and bipolar Transuretheral resection of the prostate (TURP)
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 Outcomes

Measure
BPH symptoms compared to TURP symptoms a 6 months post procedure
time frame: 6 months

Secondary Outcomes

Measure
To compare the functional status of PVP and TURP via maximum urinary flow rate (Qmax)
time frame: 6 months
To compare the complication-free rate of PVP and TURP
time frame: 6 months
To compare prostate volume post treatment for PVP and TURP
time frame: 6 months
To compare immediate post treatment outcomes of PVP and TURP
time frame: 3 weeks
To compare health status of PVP and TURP
time frame: 2 years
To compare tolerability of PVP and TURP
time frame: 2 Years
To compare subject satisfaction of PVP and TURP
time frame: 2 Years
To compare rate of retreatment of PVP and TURP
time frame: 2 Years

Eligibility Criteria

Male participants from 40 years up to 80 years old.

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)

Additional Information

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)
Principal investigator Alexander Bachman, Prof. Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by American Medical Systems.