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

Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH.

A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria.

Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up.

iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

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 < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial.
• Prostate volume between 25 ml to 75 ml (assessed by ultrasound)
• Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP)
• Subject able to comply with the study protocol
• Normal Urinalysis and urine culture

Exclusion criteria

• Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression;
• Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
• A post void residual (PVR) volume > 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.