Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

Inclusion Criteria

• Subject signed informed consent form (ICF)
• Age 50 and above
• Male with symptomatic BPH.
• IPSS symptom severity score ≥ 10
• Peak urinary flow of 250 ml measured by ultrasound or acute urinary retention
• Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease);
• Confirmed or suspected bladder cancer;
• Recent (within 3 months) cystolithiasis or hematuria;
• Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology;
• An active urinary tract infection.
• Enrolled in another treatment trial for any disease within the past 30 days.
• Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used;
• Previous pelvic irradiation, cryosurgery or radical pelvic surgery;
• Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• History of prostatitis within the past 5 years.
• Median lobe obstruction of the prostate.
• Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years).
• Any serious medical condition likely to impede successful completion of the study
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
• Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period.
• Baseline PSA ≥ 10 ng/ml.
• Positive DRE.
• Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.