A Multi-center, International Prospective Follow up Study

Study Overview
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Brief Summary
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The study objective is to assess the safety and efficacy of iTind three to five years following treatment.

Detailed Description
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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.

Official Title
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A Multi-center, International Prospective Follow up Study to Assess the Safety and Efficacy of the iTind Procedure After Three to Five Years of Follow Up

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject signed informed consent form (ICF) Subject who had participated in the MT-03 study in the iTind arm Subject able to comply with the study protocol. Exclusion Criteria: Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study Patients that are known to have had undergone an alternative surgical procedure for BPH during MT-03 study.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| iTind subjects<br>Patient who participated previously in the MT-03 study in the iTind arm | Other: Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound<br>* Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |