Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

This is an interventional treatment trial for Bladder Neck Obstruction focused on measuring BPH, bladder neck obstruction, Bladder neck obstruction secondary to BPH Read More

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