RecruitingNot Applicable

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

United States206 participantsStarted 2022-09-26

Plain-language summary

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

Age range50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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/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
✓. 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
✓. International Prostate Symptom Score (IPSS) ≥ 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

✕. 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 or suspected bladder cancer within the last 2 years
✕. 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/dl, 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

Incidence of all intraoperative and post-operative complications

Timeframe: 3 months

NCT IDNCT04757116

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Selen ZuelbaharOlgun, PhD

Who can participate

Age range50 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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/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
✓. 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
✓. International Prostate Symptom Score (IPSS) ≥ 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

✕. 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 or suspected bladder cancer within the last 2 years
✕. 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/dl, 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