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

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia (BPH)

In brief

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

Key facts

Study ID

NCT04757116

Run by

Olympus Corporation of the Americas

People needed

256

Starts

2022-09-26

Expected to finish

2030-05-31

Last updated by the study team

2026-08-03

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
• Willing and able to provide informed consent
• Males ≥ 50 years of age or older
• 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
• 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
• International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 13
• Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
• Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits

You may not qualify if…

• 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
• Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
• History of acute bacterial prostatitis within the last 2 years
• Median lobe obstruction of the prostate as confirmed by cross-sectional imaging
• PSA value > 10 ng/ml
• Contraindicated for iTind or UroLift as determined by the PI
• 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
• Clinically significant bladder diverticulum
• Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
• 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
• An active urinary tract infection during randomization
• Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
• Prostate volume > 75 cc
• Post-void residual volume (PVR) > 250 mL
• Actively using catheterization or unable to void naturally
• 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
• Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
• Known or suspected allergy to nickel, titanium or polyester/polypropylene

Where it is running

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

Full record on ClinicalTrials.gov

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