Benign Prostatic Hyperplasia (BPH) Urological and Genital Diseases Hyperplasia of prostate
Conditions
Interventions
Patients will be randomised to receive either
1. GreenLight XPS 532 nm Laser System with MoXy™ laser fiber
2. Monopolar or bipolar loop TURP systems carrying the CE mark
Sponsors
American Medical Systems, Inc (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has provided informed consent 2. Subject has diagnosis of benign prostatic hyperplasia 3. Subject is willing to be randomised 4. 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 randomised into either arm 5. Subject is greater than or equal to 40 years of age 6. Subject has an International Prostate Symptom Score (IPSS) score greater than or equal to 12 measured at the baseline visit 7. 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 125ml, and the Qmax is less than 15ml/s it may be used for the inclusion/exclusion criteria) 8. Subject has medical record documentation of a prostate volume of less than or equal to 100g by transrectal ultrasound (TRUS) or abdominal ultrasound (If TRUS or abdominal ultrasound testing documentation is available within the 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) 9. Subject is classified as American Society of Anesthesiologist (ASA) I, II or III 10. Subject has a serum creatinine less than 1.8 mg/dl measured after the date of the informed consent and prior to the surgical procedure
Exclusion criteria
Exclusion criteria: 1. Subject has a life expectancy of less than 2 years 2. Subject is currently enrolled in, or plans to enroll in, any concurrent drug or device study unless pre-approved by the sponsor 3. Subject has an active infection (eg, urinary tract infection or prostatitis) 4. Subject has a history of 2 or more urinary tract infections in the 365 days prior to the informed consent date 5. Subject has a diagnosis of chronic bacterial prostatitis or chronic pelvic pain syndrome (eg, non-bacterial chronic prostatitis) 6. Subject has been diagnosed with a urethral stricture or bladder neck contracture within the 180 days prior to the informed consent date 7. 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 8. Subject has a neurogenic bladder or other neurological disorder that would impact bladder function (eg, multiple sclerosis, Parkinson?s disease, spinal cord injuries) 9. Subject has a diagnosis of diabetic cystopathy 10. Subject has history of lower urinary tract surgery (eg, urinary diversion, artificial urinary sphincter, penile prosthesis) 11. Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad/device use 12. Subject has a history of intermittent self catheterisation within the 180 days prior to the informed consent date 13. Subject has current diagnosis of bladder stones 14. Subject has diagnosis of prostate cancer 15. Subject has a history of T1 or CIS bladder cancer 16. Subject has damage to external urinary sphincter 17. 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) 18. Subject has a disorder of the coagulation cascade (eg, haemophilia) 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 19. Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 days) 20. Subject has had an acute myocardial infarction, open heart surgery or cardiac arrest less than 180 days prior to the date of informed consent 21. Subject is immunocompromised (eg, organ transplant, leukaemia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of BPH symptoms 6 months post procedure measured by international prostate symptom score (IPSS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complication-free rates at 3 weeks post-procedure 2. Prostate volume (via TRUS or abdominal ultrasonography) as reported on the case report forms at baseline and 6-month follow-up visit 3. Functional status, measured by maximum urinary flow rate (Qmax) at 3, 6, 12, and 24-month follow-up visits (The proportion of subjects with a Qmax of 15ml/s or greater will be noted) 4. Immediate post intervention outcomes of PVP and TURP 4.1. Short Form Health Survey (SF-36) Acute at baseline and 3-week visit 4.2 Length of stay 5. Health status, measured at 3, 6, 12, and 24 month follow-up visit 5.1. International prostate symptom score (IPSS) 5.2. BPH Impact Index (BII) 5.3. Over-active Bladder Questionnaire (OABq) 5.4. SF-36 Acute 5.5. EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D) 6. Tolerability, measured at 6, 12 and 24 month follow-up visit 6.1. International Index of Erectile Function (IIEF) 6.2. International Consultation on Incontinence Questionnaire Short Form 7. Subject satisfaction, measured at end of study 8. Rate of re-treatment, measured at end of study | — |
Countries
Germany, Netherlands, United Kingdom
Outcome results
None listed