Post-Market Study to Assess iTind Safety in Comparison to UroLift
A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Eligibility
Sex: MALEMin Age: 50 Years
Plain Language Summary
Simplified for easier understanding
This study compares two minimally invasive devices for treating benign prostatic hyperplasia (BPH) — an enlarged prostate that makes it difficult to urinate. The two devices are iTind (temporary implant to widen the urethra) and UroLift (permanent implants that hold the prostate lobes apart). Both are already approved, and this study compares their real-world safety and effectiveness in men 50 years and older.
BPH is very common in older men and can significantly reduce quality of life. Unlike medications, these procedures provide mechanical relief and avoid the sexual side effects of some drug treatments. Both devices are inserted through the urethra without incisions.
You may be eligible if...
- You are a male aged 50 or older
- You have been diagnosed with lower urinary tract symptoms due to an enlarged prostate
- Your IPSS symptom score is 13 or higher
- Your prostate volume is 75 cc or less
- Your urine flow rate is between 5 and 15 mL/sec
You may NOT be eligible if...
- You have a history of prostate cancer or confirmed bladder cancer
- You have a median lobe obstruction
- You have a urinary tract infection or post-void residual volume above 250 mL
- You are currently using a urinary catheter or cannot urinate naturally
- You have had prior invasive prostate procedures or pelvic radiation
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DEVICEiTind
The iTind is implemented for 5-7 days
PROCEDUREUroLift
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Locations(19)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Arizona Urology Specialists
Tucson, Arizona, United States
Urology Associates of Central California
Fresno, California, United States
Golden State Urology
Sacramento, California, United States
NorthShore University Health System Research Institute
Evanston, Illinois, United States
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States
Minnesota Urology
Woodbury, Minnesota, United States
Adult & Pediatric Urology
Omaha, Nebraska, United States
Pacific West Urology
Las Vegas, Nevada, United States
Feinstein Institutes for Medical Research / Northwell Health
Syosset, New York, United States
The Conrad Pearson Clinic
Germantown, Tennessee, United States
Midtown Urology Associates
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
The Urology Place
San Antonio, Texas, United States
Potomac Urology Center
Alexandria, Virginia, United States
Chelsea and Westminster Hospital
Isleworth, Middlesex, United Kingdom
Queen Margaret Hospital
Dunfermline, United Kingdom
Frimley Park Hospital
London, United Kingdom
Norfolk & Norwich University Hospital
Norwich, United Kingdom
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.