MT-06One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Date de début de l'étude : 18 février 2018

Inclusion Criteria: Subject signed informed consent prior to the performance of any study procedures. * Male with symptomatic BPH: IPSS symptom severity score ≥ 10 * Peak urinary flow of \< 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc. * Prostate volume 25 ml to 80 ml (as assessed by TRUS) * Subject that is able to complete the study protocol * Normal Urinalysis and urine culture. Exclusion Criteria: * Previous prostate surgery * Prostate cancer * Urethral stricture * Bladder stones * An active urinary tract infection. * Obstructing median lobe demonstrated by IPP grade 3 (\>1 cm) as assessed by TRUS. * Neurological conditions potentially affecting voiding function. * A post void residual (PVR) volume \> 250 ml measured by ultrasound * Previous diagnosis or treatment for Over Active Bladder * Acute Urinary Retention * Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study Intra-Operation Exclusion: • Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.