Assessing Safety & Efficacy of MediTate Temporary Implant in Subjects With Benign Prostate Hyperplasia

Study Overview
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Brief Summary
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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.

Official Title
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One-arm Feasibility and Prospective Pivotal Study to Assess the Safety and Efficacy of MediTate Temporary Implantable Nitinol Device (TIND) in Subjects Presenting Bladder Outlet Obstruction Secondary to BPH

Conditions
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Bladder Neck Obstruction, Benign Prostate Hyperplasia

Intervention / Treatment
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* Device: Insertion of Temporary Implantable Nitinol Device (TIND)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main IC: Subject signed informed consent prior to the performance of any study procedures. Male with BPH, who are at least 50 years of age and that were diagnosed with BOO. IPSS symptom severity score ≥ 10. Peak urinary flow of < 12 ml/sec No pathology found with kidney US Prostatic urethra length < 30 mm Prostate volume < 35 cc Normal Urinalysis and urine culture. Exclusion Criteria: Main EC: Any prior prostate treatment Suspected or proved carcinoma of prostate Urethral stricture Urinary bladder stones Serum prostate specific antigen level > 4 ng/ml (unless proved to be carcinoma free by biopsy). Active urinary tract infection as determined by positive culture, bacterial prostatitis within the past year documented by positive culture. Median prostatic lobe enlargement or a prominent obstructing ball valve prostatic lobe. Subject has an interest in future fertility and is not willing to undergo fertility treatments whatsoever. Any serious medical condition likely to impede successful completion of the study Intraoperative EC: Irregular findings by the implanting physician during the implantation procedure by the cystoscopy that to the best of the implanting physician are exerting non compliance with the exclusion or inclusion criteria and that were not noticed previously during screening

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: device<br>Insertion of Temporary Implantable Nitinol Device (TIND) | Device: Insertion of Temporary Implantable Nitinol Device (TIND)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Maximal uroflow will be measured in each visit | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, bladder neck obstruction, Bladder neck obstruction secondary to BPH