Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia
The purpose of this study is to assess the safety and efficacy of MediTate Temporary
 Implantable Nitinol Device (TIND) used to alleviate symptoms of Bladder Outlet Obstruction
 (BOO) secondary to Benign Prostate Hyperplasia (BPH).The TIND is inserted in the bladder neck
 and prostatic urethra under local anesthesia for few days and taken out some 5 days later in
 the doctors office.
Inclusion Criteria:

 Main IC:

 -  Subject signed informed consent prior to the performance of any study procedures.

 -  Male with BPH, who are at least 50 years of age and that were diagnosed with BOO.

 -  IPSS symptom severity score ≥ 10.

 -  Peak urinary flow of < 12 ml/sec

 -  No pathology found with kidney US

 -  Prostatic urethra length < 30 mm

 -  Prostate volume < 35 cc

 -  Normal Urinalysis and urine culture.

 Exclusion Criteria:

 Main EC:

 -  Any prior prostate treatment

 -  Suspected or proved carcinoma of prostate

 -  Urethral stricture

 -  Urinary bladder stones

 -  Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by
 biopsy).

 -  Active urinary tract infection as determined by positive culture, bacterial
 prostatitis within the past year documented by positive culture.

 -  Median prostatic lobe enlargement or a prominent obstructing "ball valve" prostatic
 lobe.

 -  Subject has an interest in future fertility and is not willing to undergo fertility
 treatments whatsoever.

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

 Intraoperative EC:

 -  Irregular findings by the implanting physician during the implantation procedure by
 the cystoscopy that to the best of the implanting physician are exerting non
 compliance with the exclusion or inclusion criteria and that were not noticed
 previously during screening