RecruitingNot ApplicableNCT04757116

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)


Sponsor

Olympus Corporation of the Americas

Enrollment

206 participants

Start Date

Sep 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

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NCT04757116


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