Pivotal Study to Assess the Safety and Effectiveness of the iTind Device

Study Overview
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Brief Summary
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The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).

Detailed Description
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Medi-Tate i-Temporary Implantable Nitinol Device (iTind) is intended to treat subjects with symptomatic BPH. A total of 150 subjects with symptomatic BPH will be enrolled into this study, according to eligibility criteria. Study duration is 12 months and includes 7 visits: screening, screening follow up, implantation, retrieval, 6 weeks follow up, 3 months follow up and 12 months follow up. iTind Device will be implanted for 5-7 days. Sham will be a routine Foley catheter procedure.

Official Title
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Multi-center Prospective Study to Assess the Safety and Effectiveness of Medi-Tate i-Temporary Implantable Nitinol Device (iTind) in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Conditions
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Benign Prostate Hyperplasia

Intervention / Treatment
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* Device: iTIND
* Procedure: Sham Arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject signed informed consent form (ICF) Age 50 and above Male with symptomatic BPH. IPSS symptom severity score ≥ 10 Peak urinary flow of < 12 ml/sec . Meeting the criterion on (2) two separate voiding trials , on a minimum voided volume of at least 125 cc for each voiding trial. Prostate volume between 25 ml to 75 ml (assessed by ultrasound) Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal values of the PT, PTT and INR tests (anticoagulants should be stopped according to GCP) Subject able to comply with the study protocol Normal Urinalysis and urine culture Exclusion Criteria: Cardiac arrhythmias, cardiac disease including congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression; Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes A post void residual (PVR) volume > 250 ml measured by ultrasound or acute urinary retention Compromised renal function (i.e., serum creatinine level > 1.8 mg/dl, or upper tract disease); Confirmed or suspected bladder cancer; Recent (within 3 months) cystolithiasis or hematuria; Urethral strictures, bladder neck contracture, urinary bladder stones or other potentially confounding bladder pathology; An active urinary tract infection. Enrolled in another treatment trial for any disease within the past 30 days. Previous colo- rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy may potentially cause injury to sites of previous rectal surgery, e.g., if a transrectal probe is used; Previous pelvic irradiation, cryosurgery or radical pelvic surgery; Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate History of prostatitis within the past 5 years. Median lobe obstruction of the prostate. Cancer that is not considered cured, except basal cell or squamous cell carcinoma of the skin (cured defined as no evidence of cancer within the past 5 years). Any serious medical condition likely to impede successful completion of the study Participating in any other investigational study for either drug or device which can influence collection of valid data under this study. Subjects who are actively taking medications that affects urination and BPH symptoms not completing the required washout period. Baseline PSA ≥ 10 ng/ml. Positive DRE. Baseline PSA between 2.5-10 ng/ml and free PSA < 25%, without a subsequent negative prostate biopsy.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iTind arm<br>iTind implant is implant during the study for 5-7 days. | Device: iTIND<br>* Temporary Implantable Nitinol Device (iTIND)<br>|
| Sham Comparator: Sham arm<br>Foley catheter is used during the study | Procedure: Sham Arm<br>* Foley catheter will be placed and immediately removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Month 3 Results in the IPSS Score in Both Arms. | Month 3 results in the IPSS Score in both arms IPSS - The International Prostate Symptom Score. Scale: minimum 0 (zero), maximum 35. Lower values are better. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qmax Measurement | Month 3 results in Qmax (maximum urinary flow rate) | 3 months | 
| PVR | Month 3 results in PVR (post-void residual urine volume) | 3 months | 
| IIEF Questionnaire | The International Index of Erectile Function score. Scale: minimum 6, maximum 75. Higher values are better. Month 3 results in IIEF. | 3 months | 
| SHIM | The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM. | 3 months |