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Covid-19
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The study objective is to assess the safety and efficacy of iTind three to five years following treatment.
This study will recruit patients who participated in the MT-03 study in the iTind arm to assess the safety and efficacy of the iTind procedure at three to five years following treatment as demonstrated by reduction of symptoms measured by IPSS and QoL and improvement of functional parameters as measured by peak urinary flow and PVR. Sexual and erectile function will also be assessed alongside the incidence of any related late occurring adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTind subjects | Patient who participated previously in the MT-03 study in the iTind arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound | Other | Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests. |
| Measure | Description | Time Frame |
|---|---|---|
| iTind Durability | The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. | 36 months post procedure |
| iTind Durability | The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. | 48 months post procedure |
| iTind Durability | The primary endpoint of the study is time to first alternative surgical BPH intervention, defined as the time (in months) from the iTind procedure to intervention. | 60 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| iTind Efficacy | Change from baseline in IPSS | 36 months post procedure |
| iTind Efficacy | Change from baseline in IPSS | 48 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Any patient who participated in the MT-03 study in the iTind arm who had not undergone an alternative procedure for BPH during the first 12 month follow-up period and who is willing to participate in the current follow up study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States | ||
| Manhattan Medical research |
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| Label | URL |
|---|---|
| Company website | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| iTind Efficacy | Change from baseline in IPSS | 60 months post procedure |
| iTind Efficacy | Change from baseline in Qmax | 36 months post procedure |
| iTind Efficacy | Change from baseline in Qmax | 48 months post procedure |
| iTind Efficacy | Change from baseline in Qmax | 60 months post procedure |
| iTind Safety | Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study | 36 months post procedure |
| iTind Safety | Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study | 48 months post procedure |
| iTind Safety | Safety will be assessed by the rate of complications attributed to iTind since the last recorded follow up from MT-03 study | 60 months post procedure |
| Manhattan |
| New York |
| 10016 |
| United States |
| Premier Urology Group | New York | New York | 08857 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Toronto | Toronto | Ontario | Canada |
| D052801 |
| Male Urogenital Diseases |