Prostatic Urethral Lift in Subject With Acute Urinary Retention

Exclusion Criteria

• •1. An obstructive or protruding median lobe of the prostate
• •2. Previous BPH surgical procedure
• •3. Previous pelvic surgery
• •4. Urethral conditions that prevents insertion and delivery of device system into bladder
• •5. Retention volume of \>1500 mL
• •6. Has not had prostate cancer excluded
• •7. History of prostate or bladder cancer
• •8. Biopsy of the prostate within the 6 weeks prior to Index Procedure
• •9. History of neurogenic or atonic bladder
• •10. Acute or chronic renal failure
• •11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
• •12. Known bladder stones within the prior 3 months or treatment within 12 months
• •13. Prostatitis requiring treatment (antibiotics) within the last year
• •14. Other co-morbidities that could impact the study results
• •* severe cardiac arrhythmias uncontrolled by medications or pacemaker
• •* congestive heart failure New York Heart Association (NYHA) III or IV
• •* history of uncontrolled diabetes mellitus
• •* significant respiratory disease in which hospitalisation may be required
• •* known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
• •15. Life expectancy estimated to be less than 5 years
• •16. Desire to maintain fertility post procedure
• •17. Unable or unwilling to complete all required questionnaires and follow up assessments
• •18. Unable or unwilling to sign informed consent form
• •19. Currently enroled in any other clinical research trial that has not completed the primary endpoint