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Clinical Trials in the USA / NCT04757116
Recruiting Not applicable

Post-Market Study to Assess iTind Safety in Comparison to UroLift

NCT04757116 · tracked via the Priya Life Science USA tracker
Sponsor
Olympus Corporation of the Americas
Phase
Not applicable
Started
2022-09-26
Last updated
2026-08-03

Condition(s) studied

Benign Prostatic Hyperplasia (BPH)

Investigational drug(s) / intervention(s)

iTindUroLift

iTind: The iTind is implemented for 5-7 days

UroLift: UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

Study summary

The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.

Eligibility

Sex
MALE
Min age
50 Years
Max age
—
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/ml or if the PSA is 4 - 10 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 standard of care imaging may be accepted up to 6 months prior to Screening 6. International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13 7. Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL) 8. Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits Exclusion Criteria: 1. History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local standard of care methods within prior 6 months 2. Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer 3. History of acute bacterial prostatitis within the last 2 years 4. Median lobe obstruction of the prostate as confirmed by cross-sectional imaging 5. PSA value \> 10 ng/ml 6. Contraindicated for iTind or UroLift as determined by the PI 7. Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes or other neurological disorders that affect bladder function 8. Clinically significant bladder diverticulum 9. Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter 10. Prior rectal surgery (other than hemorrhoidectomy) or history of rectal disease treatment if the therapy may potentially cause injury to site (e.g., if a transrectal probe is used), pelvic radiotherapy or radical pelvic surgery, urinary diversion surgery, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or any other invasive treatment to the prostate, or penile prosthesis if it may prevent insertion of the iTind or UroLift device 11. An active urinary tract infection during randomization 12. Clinically significant hematuria within the last 3 months or ongoing cystolithiasis 13. Prostate volume \> 75 cc 14. Post-void residual volume (PVR) \> 250 mL 15. Actively using catheterization or unable to void naturally 16. Unable to complete a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure 17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure 18. Known or suspected allergy to nickel, titanium or polyester/polypropylene

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Mayo Clinic Arizona Phoenix Arizona Recruiting
Arizona Urology Specialists Tucson Arizona Terminated
Urology Associates of Central California Fresno California Recruiting
Golden State Urology Sacramento California Recruiting
NorthShore University Health System Research Institute Evanston Illinois Terminated
Southeast Louisiana Veterans Health Care System New Orleans Louisiana Recruiting
Minnesota Urology Woodbury Minnesota Recruiting
The Urology Center Omaha Nebraska Recruiting
Pacific West Urology Las Vegas Nevada Recruiting
Feinstein Institutes for Medical Research / Northwell Health Syosset New York Recruiting
The Conrad Pearson Clinic Germantown Tennessee Recruiting
Midtown Urology Associates Austin Texas Recruiting
Houston Metro Urology Houston Texas Recruiting
The Urology Place San Antonio Texas Recruiting
Potomac Urology Center Alexandria Virginia Recruiting
Chelsea and Westminster Hospital Isleworth Middlesex Recruiting
Queen Margaret Hospital Dunfermline United Kingdom Recruiting
Frimley Park Hospital London United Kingdom Recruiting
Norfolk & Norwich University Hospital Norwich United Kingdom Recruiting

More Olympus Corporation of the Americas trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04757116 on ClinicalTrials.gov ↗ ← All trials in the USA