Status:
RECRUITING
Post-Market Study to Assess iTind Safety in Comparison to UroLift
Lead Sponsor:
Olympus Corporation of the Americas
Collaborating Sponsors:
Olympus Europe SE & Co. KG
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
50+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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 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
- An active urinary tract infection
- Hematuria or cystolithiasis within the last 3 months
- Prostate volume \> 75 cc
- Post-void residual volume (PVR) \> 250 mL
- Actively using catheterization or unable to void naturally
- Unable to complete the required washout period for alpha blockers
- Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to randomization
- Known or suspected allergy to nickel, titanium or polyester/polypropylene
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04757116
Start Date
September 26 2022
End Date
December 31 2031
Last Update
October 31 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
2
Arizona Urology Specialists
Tucson, Arizona, United States, 85704
3
Urology Associates of Central California
Fresno, California, United States, 93720
4
Golden State Urology
Sacramento, California, United States, 95823