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NCT04757116NARecruiting

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

Olympus Corporation of the Americas

Start Date

9/26/2022

Completion Date

12/31/2031

Summary

The study objective is to evaluate the safety of the iTind device comparied to UroLift.

Detailed 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 effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.

Eligibility Criteria

Age Range: 50 years to No maximum

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 standard of care imaging may be accepted up to 6 months prior to Screening if the subject was not on 5-alpha reductase inhibitors (5ARIs) at that time 6. International Prostate Symptom Score (IPSS) ≥ 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 or suspected bladder cancer within the last 2 years 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/dl, 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 if the therapy may potentially cause injury to sites or previous rectal surgery (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 that may prevent insertion of the iTind or UroLift device 11. An active urinary tract infection 12. Hematuria or cystolithiasis within the last 3 months 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 the required washout period for alpha blockers 17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to randomization 18. Known or suspected allergy to nickel, titanium or polyester/polypropylene

Interventions

DEVICE

iTind

PROCEDURE

UroLift

Interested in This Trial?

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Conditions

Benign Prostatic Hyperplasia (BPH)

Locations

Mayo Clinic Arizona

Phoenix, Arizona 85054

United States

Arizona Urology Specialists

Tucson, Arizona 85704

United States

Urology Associates of Central California

Fresno, California 93720

United States

Golden State Urology

Sacramento, California 95823

United States

NorthShore University Health System Research Institute

Evanston, Illinois 60201

United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana 70119

United States

Minnesota Urology

Woodbury, Minnesota 55125

United States

Adult & Pediatric Urology

Omaha, Nebraska 68124

United States

Pacific West Urology

Las Vegas, Nevada 89121

United States

Feinstein Institutes for Medical Research / Northwell Health

Syosset, New York 11791

United States

The Conrad Pearson Clinic

Germantown, Tennessee 38138

United States

Midtown Urology Associates

Austin, Texas 78705

United States

Houston Metro Urology

Houston, Texas 77027

United States

The Urology Place

San Antonio, Texas 78240

United States

Potomac Urology Center

Alexandria, Virginia 22311

United States

Chelsea and Westminster Hospital

Isleworth, Middlesex TW7 6AF

United Kingdom

Queen Margaret Hospital

Dunfermline, KY12 0SU

United Kingdom

Frimley Park Hospital

London, GU16 7UJ

United Kingdom

Norfolk & Norwich University Hospital

Norwich, NR4 7UY

United Kingdom