Neuflo System for the Treatment of BPH

Inclusion Criteria: Participants must meet all inclusion criteria to participate in this study.

1. Males aged 45 years of age or older
2. IPSS score of 13 or higher
3. Eligible uroflow with unadjusted or adjusted peak flow rate of equal to or less than 13ml/sec with a corresponding:
4. voided volume of at least 100 ml, and,
5. Post Void Residual (PVR) of 250 ml or less
6. Prostate volume of 25-80 cm3, inclusive as measured by ultrasound or MRI
7. Prostatic sagittal length of 3.2 cm or greater, as measured by ultrasound or MRI
8. Prostatic transverse width of 3.5 cm or greater as measured by ultrasound or MRI
9. Prostatic anterior-posterior height of 2.5 cm or greater as measured by ultrasound orMRI
10. Participant must have the ability to understand and consent to participate in thisstudy
11. Participant must be willing and able to participate in follow-up evaluations

Exclusion Criteria: Participants meeting any of the exclusion criteria listed at baseline will be excluded fromparticipation.

1. Outlet obstruction due to an enlarged middle lobe or significant central gland of theprostate
2. Significant transverse asymmetry of prostatic lateral lobes
3. Participant has an implantable pacemaker or cardiac defibrillator
4. Participant has a penile implant
5. History or current diagnosis of prostate cancer or bladder cancer
6. Active urinary tract infection (UTI) (Note: participant can be enrolled if the UTI istreated and followed with a negative urine test result)
7. Neurogenic, decompensated, or atonic bladder
8. Overactive bladder in the absence of prostatic obstruction
9. Current, recurrent (two or more) urethral strictures or muscle spasms that preventinsertion of the catheter
10. Bleeding disorders or takes anticoagulation medications unless anti-plateletmedication has been discontinued for at least 7 days prior to treatment (Participantsare allowed to delay or repeat screening to fulfil this requirement)
11. Previous rectal surgery other than haemorrhoidectomy
12. Previous radical pelvic surgery or pelvic irradiation
13. Interest in maintaining fertility
14. Previous surgery or minimally invasive procedure(s) to treat symptomatic BPH
15. Use of Alpha blocker for the treatment of BPH within 14 days of treatment date. (Participants are allowed to delay or repeat screening to fulfil this requirement)
16. 5-ARI (5-alpha-reductase inhibitor), (an enzyme inhibitor) use within 3 months oftreatment date (Participants are allowed to delay screening to fulfil thisrequirement)
17. Concomitant bladder stones
18. History of other diseases or conditions causing voiding dysfunction
19. Current medication affecting bladder function
20. Known allergy to nickel
21. Chronic prostatitis, recurrent prostatitis, chronic pelvic pain syndrome (CPPS), orpainful bladder syndrome within the past 12 months
22. History of medical, surgical, or other conditions that, in the opinion of theinvestigator, would limit study participation