Safety and Effectiveness Study of the Zenflow Spring System

Exclusion Criteria

• •1. Obstructive intravesical median prostatic lobe as determined by ultrasound (i.e., more than 10 mm intravesical prostatic protrusion on sagittal mid-prostate plane via abdominal ultrasound),
• •2. High bladder neck with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction as determined by the Investigator,
• •3. Urethral stricture, meatal stenosis, or bladder neck stricture - either current or recurrent,
• •4. Anatomical anomalies that will not accommodate the Implant, as determined by cystoscopy (e.g., prostatic urethral length to height geometry),
• •5. Requires indwelling catheter or intermittent catheterization to void,
• •6. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction),
• •7. One of the following baseline test results, taken from a single uroflowmetry reading:
• •1. Urinary volume void ≤ 125mL (pre-bladder urinary volume of ≥ 150 mL required),
• •2. Peak urinary flow rate (Qmax) of ≤ 5 ml/second or \> 15 mL/second,
• •3. Post- void residual volume (PVR) \> 250 mL
• •8. History of other diseases causing voiding dysfunction including urinary retention (e.g., uncontrolled diabetes, diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, etc.),
• •9. Subjects with overactive bladder in the absence of benign prostatic obstruction,
• •10. Acute urinary tract infection (UTI) or finding of asymptomatic bacteriuria (Note: subject can be enrolled if the UTI is treated and followed with a negative urine test result), or subjects with history of recurrent UTIs (defined as \> 3 UTIs in the past 12 months),
• •11. Concomitant bladder stones,
• •12. Previous pelvic irradiation or radical pelvic surgery,
• •13. Previous prostate surgery, including: enucleation, resection, vaporization, thermotherapy, ablation, stenting or prostatic urethral lift,
• •14. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), or painful bladder syndrome within the past 12 months
• •15. Known allergy to nickel,
• •16. Life expectancy less than 60 months,
• •17. Use of concomitant medications (e.g., anticholinergics, antispasmodics or tricyclic antidepressants) affecting bladder function,
• •18. Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure (Note: low dose aspirin therapy (81 mg) is permitted),
• •19. Taking 5-alpha-reductase inhibitors within 3 months of baseline evaluation,
• •20. Taking one of the following within 2 weeks of baseline evaluation:
• •1. alpha-blockers,
• •2. imipramine,
• •3. anticholinergics,
• •4. cholinergic gonadotropin releasing hormonal analogues,
• •5. Phosphodiesterase-5 Enzyme Inhibitors (Tadalafil) in doses for BPH,
• •6. Beta-3 adrenergic receptor agonist (Mirabegron),
• •21. Taking androgens, unless eugonadal state for at least 3 months or greater as documented by the Investigator,
• •22. Taking one of the following within 24 hours of pre-treatment (baseline) evaluation:
• •1. phenylephrine, or,
• •2. pseudoephedrine,
• •23. Future fertility concerns, or,
• •24. In the Investigator's opinion, the subject has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).