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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.
Meir Medical center
Kfar Saba, Israel
Device related and unanticipated SAE
Device related and unanticipated SAEs will be followed. No such SAEs are expected.
Time frame: At 3 months
Reduce at least 3 point in the International Prostate Symptom Score (IPSS) in at least 75% of subjects
Questionnaire of IPSS will be done in each visit.
Time frame: At 3 months
Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects
Maximal uroflow will be measured in each visit
Time frame: At 3 months
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