ProVee Urethral Expander System IDE Study (ProVIDE)

Inclusion Criteria:

1. Males > 45 years of age

2. IPSS of ≥ 13, IPSS V/S > 1 at baseline assessment

3. Prostate volume of ≥ 30 cc and ≤ 80 cc

4. Prostatic urethral L2 lengths ≥ 3.75cm by TRUS

5. Failed, intolerant, or subject choice to not take a medication regimen for thetreatment of LUTS

Exclusion Criteria:

1. Void volume <125 ml; Qmax > 12ml/s; PVR > 250 ml

2. Obstructive median lobe defined by EITHER (>10mm protrusion on sagittal mid-prostateplane as measured by TRUS) OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve''

3. High bladder neck, with the absence of lateral lobe encroachment indicating a highlikelihood of primary bladder neck obstruction

4. Anatomy that would prevent the apices of the ProVee from engaging with the laterallobes e.g., high degree of bladder neck angulation such that the anterior bladderneck is not visible

5. Acute urinary retention

6. Known immunosuppression

7. History of or suspected prostate or bladder cancer

8. Baseline PSA > 10 ng/mL or confirmed or suspected prostate cancer (Subjects with aPSA level above 2.5 ng/mL, or age specific, or local reference ranges should haveprostate cancer excluded to the Investigator's satisfaction, including a SOC biopsyif indicated).

9. Recent urinary tract stones, OR widespread calcifications on the prostatic urethralwall, within 3 months of index procedure

10. A history of prostatitis within the last two years

11. Active or history of epididymitis within the past 3 months

12. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease,multiple sclerosis, cerebral vascular accident, diabetes'

13. History of urinary retention within 12 months of baseline assessment

14. Requiring self-catheterization to void

15. An active urinary tract infection (UTI) at time of index procedure

16. Gross haematuria, within 3 months of index procedure

17. Subjects with known allergy to nickel or titanium

18. Life expectancy estimated to be less than 60 months

19. Taking androgens, unless eugonadal state for at least 3 months or greater with astable dosage for at least 2 months as documented by the Investigator

20. Use of 5-alpha-reductase inhibitors (e.g., dutasteride, finasteride) within 6 monthsof baseline assessment

21. Use of Phenylephrine / Pseudoephedrine within 24 hours of baseline assessment

22. Use of alpha-blockers (e.g., Terazosin, Doxazosin, Alfuzosin, Tamsulosin) within 2weeks of baseline assessment

23. Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasinghormonal analogues) within 1 year of baseline assessment

24. Use of antihistamines, anticonvulsants, and antispasmodics within 1 week of baselineassessment unless there is documented evidence that the patient was on the same drugdose for at least 6 months with a stable voiding pattern (the drug dose should notbe altered or discontinued for entrance into or throughout the study)

25. Use of anticholinergics or cholinergic medication within 2 weeks of baselineassessment

26. Use of beta-blockers where the dose is not stable. (Stable dose is defined as havingthe same medication and dose in the last 6 months)

27. Use of Phosphodiesterase-5 Enzyme Inhibitors in doses for BPH within 2 weeks ofbaseline assessment

28. Current treatment with anticoagulants (e.g., warfarin or enoxaparin) or antiplateletmedications other than aspirin (e.g., clopidogrel, or alternative and ASA). Patientunable to stop taking antiplatelet and/or antiplatelets within 3 days prior to theprocedure or warfarin at least 5 days prior to the procedure. Low dose aspirin ≤100mg/day not prohibited

29. Future fertility concerns

30. Previous prostate surgery, balloon dilatation, stent implantation, laserprostatectomy, hyperthermia, or any other invasive treatment to the prostate;including penile implants

31. Previous pelvic irradiation or radical pelvic surgery

32. Previous rectal surgery (other than hemorrhoidectomy) or known history of rectaldisease

33. Urethral strictures, bladder neck contracture, or other potentially confoundingbladder pathology

34. Urethral pathologies that may prevent insertion of Delivery System

35. Uncontrolled diabetes mellitus including Hgb AIC >8%

36. Overactive bladder (OAB) requiring treatment by OAB medication

37. Urinary incontinence

38. Patients taking tri-cyclic antidepressants.

39. Compromised renal function (i.e., serum creatinine >1.8 mg/dl or upper tractdisease)

40. Hepatic disorder, bleeding disorders or metabolic impairment that might confound theresults of the study or have a risk to subject per investigator's opinion

41. Any major comorbidities or presence of unstable conditions, e.g., uncontrolled HTN,NYHA Class III or IV, cardiac arrhythmias that are not controlled bymedication/medical device, myocardial infarction within the past 6 months, COPD withFEV1 <50, renal illness that might prevent study completion or would confound studyresults

42. Vulnerable populations such as incarcerated or institutionalized adults, inmates,patients with physical, psychological (such as developmentally delayed adults), ormedical impairment that might, in the judgment of the Investigator, prevent studycompletion or comprehension, or may confound study results (including patientquestionnaires)

43. History or current medical condition that would result in an unacceptable patientrisk if that subject were to be included in the study

44. Any subject that is currently enrolled in another ongoing investigational study.