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

Boston Scientific

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: Transurethral Resection of the Prostate

Device: Photoselective Vaporization of the Prostate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01218672

PE1006

Details and patient eligibility

About

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).

Full 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.

Enrollment

291 patients

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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)