Study to Assess the Efficacy of the iTind in Subjects With Symptomatic BPH

Study Overview
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Brief Summary
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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.

Detailed Description
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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: To further evaluate the efficacy of Medi-Tate iTind as determined by increase of maximal urinary peak flow, satisfaction from the device and procedures, sex performance capabilities and ejaculation. Safety will be assessed by the rate of complications attributed to the Medi-Tate iTind and its implantation/retrieval procedures.

Official Title
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One-arm, Multi-center, International Prospective Study to Assess the Efficacy of Medi-tate Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Conditions
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BPH

Intervention / Treatment
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* Device: iTind


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject signed informed consent prior to the performance of any study procedures. Male with symptomatic BPH: IPSS symptom severity score ≥ 10 Peak urinary flow of < 12 ml/sec at flowmetry with minimum voided volume of at least 120 cc. Prostate volume 25 ml to 80 ml (as assessed by TRUS) Subject that is able to complete the study protocol Normal Urinalysis and urine culture. Exclusion Criteria: Previous prostate surgery Prostate cancer Urethral stricture Bladder stones An active urinary tract infection. Obstructing median lobe demonstrated by IPP grade 3 (>1 cm) as assessed by TRUS. Neurological conditions potentially affecting voiding function. A post void residual (PVR) volume > 250 ml measured by ultrasound Previous diagnosis or treatment for Over Active Bladder Acute Urinary Retention Any anatomical or physiological condition that in the opinion of the investigator likely to impede successful completion of the study Intra-Operation Exclusion: • Obstructing median lobe or any other anatomical or physiological pathology that can interfere the device implantation as assessed by cystoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: device group only
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>ITind device implant | Device: iTind<br>* device implanted for 5-7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS (International Prostate Symptoms Score) Responders Rate | the Proportion (%) of Total IPSS Responders (3 points) Rate | at Month 6 Visit | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |