Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Condition: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Hypertrophy
Intervention: Optilume™ BPH Prostatic DCB Dilation Catheter; Paclitaxel
Intervention description: BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).; paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: treatment group - treated with Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
Masking: None (Open Label)
Enrollment: 80.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: BPH

Summary:

      A prospective, non-randomized study. The subjects will be enrolled and treated with the
      Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The
      post-treatment follow-up visit can be up to 5 years.

      The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH
      Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13)
             and is a candidate for interventional therapy

          2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)

          3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of
             ≥ 125 ml

          4. Post-void residual (PVR) ≤ 250 ml

          5. Prostate volume 20 - 80 gm as determined by TRUS

          6. Prostatic urethra length is 35 - 55 mm as determined by TRUS

          7. Able to complete the study protocol in the opinion of the investigator

        Exclusion Criteria:

          1. Interested in maintaining fertility and unwilling to use protected sex for the first
             30 days post treatment

          2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if
             sexual partner is of child bearing potential

          3. Presence of a penile implant or stent(s) in the urethra or prostate

          4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm,
             UroLift) or surgical intervention of the prostate

          5. PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and
             ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator
             via additional tests including digital rectal exam (DRE) and/or biopsy

          6. Confirmed or suspected malignancy of prostate or bladder

          7. Active or history of epididymitis within the past 3 months

          8. Previous pelvic irradiation or radical pelvic surgery

          9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis
             within last year documented by culture (UTI is defined as >100,000 colonies per ml
             urine from midstream clean catch or catheterization specimen)

         10. Visible hematuria with subject urine sample without known contributing factor

         11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might
             affect bladder or sphincter function

         12. Previous or current diagnosis of urethral strictures, bladder neck contracture or
             detrusor muscle spasms

         13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week
             prior to treatment unless there is documented evidence of stable dosing for last 6
             months (no dose changes)

         14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil
             or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior
             to treatment

         15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment

         16. Incidence of spontaneous urinary retention within 6 months prior to baseline
             assessment

         17. Post-void residual volume > 250 ml or catheter dependent bladder drainage

         18. Overactive bladder (OAB) or urge incontinence

         19. Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)

         20. Current bladder stones or prostatic calculi

         21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days
             following the procedure

         22. History of cancer in non-genitourinary system which is not considered cured (except
             basal cell or squamous cell carcinoma of the skin). A potential participant is
             considered cured if there has been no evidence of cancer within five years

         23. History of clinically significant comorbidities or presence of unstable conditions
             (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding
             disorders, or metabolic impairment) that may confound the results of the study or have
             a risk to subject per investigator's opinion

         24. Any cognitive disorder that interferes with or precludes direct and accurate
             communication with the study investigator regarding the study or affects the ability
             to complete the study quality of life questionnaires

         25. Expected life expectancy < one year

         26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the
             follow-up requirements

         27. Currently enrolled in or plan to enroll in another investigational clinical trial for
             any disease except for observational only study

         28. In the opinion of the investigator, it is not in the subject's best interest to
             participate in the study

         29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet
             medications other than aspirin (e.g., clopidogrel)

         30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for
             treatment in this study

         31. Device that corresponds with the subject's prostate size per the IFU is not available

         32. Intravesical prostatic protrusion (IPP) > 1 cm

         33. Current uncontrolled diabetes (hemoglobin A1c > 7%)

         34. Unable or unwilling to provide all the protocol-required semen samples

         35. Sensitivity to paclitaxel, on medication that may have negative interaction with
             paclitaxel, or contraindicated for systemic paclitaxel