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

Launched by OLYMPUS CORPORATION OF THE AMERICAS · Feb 14, 2021

Keywords

ClinConnect Summary

This clinical trial is designed to compare the safety of two medical devices, iTind and UroLift, for treating a condition called benign prostatic hyperplasia (BPH), which is when the prostate gland becomes enlarged and causes problems with urination. The study is currently looking for male participants who are at least 50 years old and have symptoms that suggest their urinary issues are related to this prostate condition. To qualify, participants must also have a certain level of prostate-specific antigen (PSA) in their blood and meet specific criteria related to their urinary flow and prostate size.

If you decide to participate, you’ll need to attend several visits where you’ll fill out questionnaires and may undergo tests to evaluate your symptoms and overall health. It's important to note that there are certain conditions that would prevent someone from joining, such as a history of prostate or bladder cancer, and some other health issues. This study is a great opportunity to help researchers understand which treatment may be safer for managing urinary symptoms related to BPH.

Gender

MALE

Eligibility criteria

• 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