Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH
A total of up to 200 Symptomatic BPH subjects subjects will be enrolled into the study.

 Study duration will be 12 months post implantation with a follow-up visits at Year 2 and Year
 3.
Primary Study Objective:

 The study's primary objective is to assess the efficacy of the Medi-Tate iTind in subjects
 with symptomatic BPH by reduction of IPSS) (International Prostate Symptoms Score) score.

 Secondary Study Objectives:

 -  To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal
 urinary peak flow, satisfaction from the device and procedures, sex performance
 capabilities and ejaculation.

 -  Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind
 and its implantation/retrieval procedures.
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.