Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
Pivotal Study to Assess the Safety and Effectiveness of the iTind Device
The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as
 compared to control group (catheter only).
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:

 1. Subject signed informed consent form (ICF)

 2. Age 50 and above

 3. Male with symptomatic BPH.

 4. IPSS symptom severity score ≥ 10

 5. 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.

 6. Prostate volume between 25 ml to 75 ml (assessed by ultrasound)

 7. 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)

 8. Subject able to comply with the study protocol

 9. Normal Urinalysis and urine culture

 Exclusion Criteria:

 10. Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled
 diabetes mellitus, significant respiratory disease, or known immunosuppression;

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

 12. A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary
 retention

 13. Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract
 disease);

 14. Confirmed or suspected bladder cancer;

 15. Recent (within 3 months) cystolithiasis or hematuria;

 16. Urethral strictures, bladder neck contracture, urinary bladder stones or other
 potentially confounding bladder pathology;

 17. An active urinary tract infection.

 18. Enrolled in another treatment trial for any disease within the past 30 days.

 19. 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;

 20. Previous pelvic irradiation, cryosurgery or radical pelvic surgery;

 21. Previous prostate surgery, balloon dilatation, stent implantation, laser
 prostatectomy, hyperthermia, or any other invasive treatment to the prostate

 22. History of prostatitis within the past 5 years.

 23. Median lobe obstruction of the prostate.

 24. 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).

 25. Any serious medical condition likely to impede successful completion of the study

 26. Participating in any other investigational study for either drug or device which can
 influence collection of valid data under this study.

 27. Subjects who are actively taking medications that affects urination and BPH symptoms
 not completing the required washout period.

 28. Baseline PSA ≥ 10 ng/ml.

 29. Positive DRE.

 30. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative
 prostate biopsy.