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Tests treatment safety and results for Benign Prostatic Hyperplasia (BPH)
Official title Post-Market Study to Assess iTind Safety in Comparison to UroLift
ClinicalTrials.gov ID: NCT04757116
What this study is testing
- What it's testing
- The study objective is to evaluate the safety of the iTind device comparied to UroLift.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which...
- 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)...
- Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from standard of care imaging may be...
You likely can't join 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 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
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fresno, California, United States
- Sacramento, California, United States
- Evanston, Illinois, United States
- New Orleans, Louisiana, United States
- Woodbury, Minnesota, United States
- Omaha, Nebraska, United States
- Las Vegas, Nevada, United States
- Syosset, New York, United States
- Germantown, Tennessee, United States
- Austin, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Alexandria, Virginia, United States
- Isleworth, Middlesex, United Kingdom
- Dunfermline, United Kingdom
- London, United Kingdom
- Norwich, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Tucson, Arizona, United States; Fresno, California, United States; Sacramento, California, United States; Evanston, Illinois, United States; New Orleans, Louisiana, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.