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)
Olympus Corporation of the Americas
Summary
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
Description
Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effecti…
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended 2. Willing and able to provide informed consent 3. Males ≥ 50 years of age or older 4. PSA \< 4 ng/dl, ng/ml or if the PSA is 4 - 10 ng/dl, ng/ml, prostate cancer must be ruled out to the satisfaction of the Principal Investigator (PI) by local standard of care methods within prior 6 months 5. Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from st…
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 ArizonaPhoenix, Arizona
- Arizona Urology SpecialistsTucson, Arizona
- Urology Associates of Central CaliforniaFresno, California
- Golden State UrologySacramento, California
- NorthShore University Health System Research InstituteEvanston, Illinois
- Southeast Louisiana Veterans Health Care SystemNew Orleans, Louisiana