The study objectives are to demonstrate the efficacy and safety of the Medi-Tate iTIND as compared to control group (catheter only).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
185
Clinical Research Center of Florida
Pompano Beach, Florida, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Methodist Hospital
Brooklyn, New York, United States
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.
Time frame: 3 months
Qmax Measurement
Month 3 results in Qmax (maximum urinary flow rate)
Time frame: 3 months
PVR
Month 3 results in PVR (post-void residual urine volume)
Time frame: 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.
Time frame: 3 months
SHIM
The Sexual Health Inventory for Men questionnaire. Scale: minimum 1, maximum 25. Higher values are better. Month 3 results in SHIM.
Time frame: 3 months
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Winthrop University
Garden City, New York, United States
St John's Episcopal
Lawrence, New York, United States
Integrated Medical Professionals
Long Island City, New York, United States
Manhattan Medical research
Manhattan, New York, United States
Weill cornell
Manhattan, New York, United States
Premier Urology Group
New York, New York, United States
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Poughkeepsie, New York, United States
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