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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Photoselective Vaporization of the Prostate
* Device: Transurethral Resection of the Prostate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GreenLight XPS<br>Photoselective vaporization of the prostate using GreenLight XPS laser system. | Device: Photoselective Vaporization of the Prostate<br>* 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.<br>|
| Active Comparator: Transurethral Resection of the Prostate<br>Monopolar and bipolar Transuretheral resection of the prostate (TURP) | Device: Transurethral Resection of the Prostate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Urinary Flow Rate (Qmax) | Qmax measured from a void of at least 150 ml in volume. | 6 months | 
| Freedom From Complications | A complication is defined as a device or procedure-related adverse event meeting at least 1 of the following criteria: Perforation of tissue or a physiologic structure; Required a prolonged or secondary hospitalization; Required surgical or invasive intervention (e.g., breaking of the skin) and excluding urinary catheterization for transient retention lasting less than 7 days and/or IV medications related to anesthesia. | 180 days | 
| Prostate Volume | Prostate volume measured via transrectal ultrasound | 6 months | 
| Post Treatment Outcomes of PVP and TURP | Short Form Health Survey (SF-36 Acute) collected at 3-week visit. The SF-36 is a multi-purpose, short-form, health survey of functional health and well-being scores in a three-section format: Utility Index (score = 0-1 with higher score being better); Physical Component Summary (PCS) comprising of physical functioning, role-physical, bodily pain, and overall general health; Mental Component Summary (MCS) comprising of vitality, social functioning, role-emotional, and mental health. Each component in the PCS and MCS sections have a score of 1-100 with the higher score being better. The acute version uses a 1-week recall period. | 3 weeks post treatment | 
| Immediate Post Treatment Outcomes of PVP and TURP | Length of stay calculated as the difference from entering the recovery room date/time to discharge date/time | 3 weeks | 
| Health Status of PVP and TURP | The IPSS, OABq, SF-36 Health Summary and EQ-5D instruments will be scored. IPSS classifies voiding symptoms with scores from 0-35 (asymptomatic to very symptomatic). The OABq captures overactive bladder symptom bother with scores from 0-100 (lower score is better). The SF-36 is a health survey with scores from 1-100 (higher score is better). EQ-5D assesses health status across a range of conditions and treatments with a score of 0-1 (higher score is better). | Baseline and 24-months | 
| Tolerability of PVP and TURP Assessed Using International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | The International Index of Erectile Function (IIEF-5) and International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) instruments will be collected at baseline and the follow-up visits. The IIEF-5 is a self-administered 5 question instrument that assesses the relevant domains of male sexual function such as erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction with a total possible score of 5-25 (higher score is better). The ICIQ-SFis a self-administered 4-question tool designed for the assessment and quantification of incontinence and its impact on quality of life during the previous 4 weeks with a total score of 0-21 (higher score is worse). | Baseline, 12-months, and 24-months | 
| Subject Satisfaction of PVP and TURP | Subject responses to satisfaction with treatment as collected on follow-up visits. Data presented below indicates responses from subjects that would go through study treatment again at each of the defined follow-up visits. | 3-weeks, 3-months, 6-months, 12-months, and 24-months | 
| Rate of Retreatment of PVP and TURP | Subject experiencing a retreatment (removal of tissue via TUPR, PVP, or other intervention) for obstruction after the initial procedure was required | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Benign Prostatic Hyperplasia