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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| device | Experimental | Insertion of Temporary Implantable Nitinol Device (TIND) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of Temporary Implantable Nitinol Device (TIND) | Device | 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Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office. |
| Measure | Description | Time Frame |
|---|---|---|
| Device related and unanticipated SAE | Device related and unanticipated SAEs will be followed. No such SAEs are expected. | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3 months |
| Increase of maximal urinary peak flow by at least 3 ml/s in at least 75% of subjects |
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Inclusion Criteria:
Main IC:
Exclusion Criteria:
Main EC:
Intraoperative EC:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Farfara, MD | Bnai Zion Medical Center, Haifa, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical center | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D001748 | Urinary Bladder Neck Obstruction |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Maximal uroflow will be measured in each visit |
| At 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |