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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Experimental | ITind device implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTind | Device | device implanted for 5-7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| IPSS (International Prostate Symptoms Score) Responders Rate | the Proportion (%) of Total IPSS Responders (3 points) Rate | at Month 6 Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Total IPSS (International Prostate Symptoms Score) Score at | Change from Baseline to Month 6 in Total IPSS Score | 6 months |
| Total IPSS(International Prostate Symptoms Score) Urinary Symptoms Score |
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Inclusion Criteria:
Subject signed informed consent prior to the performance of any study procedures.
Exclusion Criteria:
Intra-Operation Exclusion:
• Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.
Male with symptomatic BPH
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Porpiglia, MD | San Orbessano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Adventist Hospital Clinical School of the University of Sydney | Sydney | Australia | ||||
| Hospital Center University De Bordeaux |
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device group only
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Change from Baseline to Month 6 in Total IPSS Urinary Symptoms Score
| 6 months |
| Total SHIM (Sexual Health Inventory for Men ) Score | Change from Baseline to Month 6 in Total SHIM Score | 6 months |
| Total ISI (Incontinence Severity Index ) Score | Change from Baseline to Month 6 in Total ISI Score | 6 months |
| Total EJ-MSHQ ( Ejaculation- Male Sexual Health questionnaire) Score | Change from Baseline to Month 6 in Total EJ-MSHQ Score | 6 months |
| Total Flow | Change from Baseline to Month 6 in Total Flow | 6 months |
| Total residual urine | Change from Baseline to Month 6 in Total residual urine | 6 months |
| Total Satisfaction Rate | Change from Baseline to Month 6 in Total Satisfaction Rate | 6 months |
| IPSS QoL (Quality Of Life) score | Change from Baseline to Month 6 in IPSS QoL score | 6 months |
| Recovery Success Rate | Quality of Recovery Success Rate | 1 month |
| Bordeaux |
| France |
| Hôpital Cochin | Paris | France |
| Hôpital Privé des Côtes d'Armor | Plérin | France |
| University Hospital Frankfurt | Frankfurt | Germany |
| Medical center - University of Freiburg | Freiburg im Breisgau | Germany |
| AOU di Catanzaro | Catanzaro | Italy |
| Azienda Ospedaliera Universitaria San Martino | Genova | Italy |
| San'Andrea Hospital | Rome | Italy |
| San Orbessano | Turin | Italy |
| Clínica CEMTRO Ventisquero la Condesa | Madrid | 42 28035 | Spain |
| Cantonal Hospital St. Gallen | Sankt Gallen | Switzerland |