Comparing the safety of iTind and UroLift for treating BPH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of the iTind device in comparison to the UroLift procedure for treating lower urinary tract symptoms caused by benign prostatic hyperplasia (BPH). Both treatments are minimally invasive options aimed at relieving symptoms associated with BPH. The study will involve male participants aged 50 and older who meet specific eligibility criteria, including certain prostate volume and symptom severity parameters. Participants will undergo assessments to compare the effectiveness and safety profiles of the two devices.

Why it matters

Who can join: the full rules

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/ml or if the PSA is 4 - 10 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
6. International Prostate Symptom Score (IPSS) for urinary symptoms ≥ 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 bladder cancer within the last 2 years or currently suspected bladder cancer
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/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 treatment if the therapy may potentially cause injury to site (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 if it may prevent insertion of the iTind or UroLift device
11. An active urinary tract infection during randomization
12. Clinically significant hematuria within the last 3 months or ongoing cystolithiasis
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 a 2-week washout period for alpha blockers prior to procedure or unable to discontinue 5ARIs or daily use of PDE5 inhibitors by the time of procedure
17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days prior to procedure
18. Known or suspected allergy to nickel, titanium or polyester/polypropylene

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• Urology Associates of Central California
  Fresno, California, United States Recruiting
• Golden State Urology
  Sacramento, California, United States Recruiting
• The Urology Center
  Omaha, Nebraska, United States Recruiting
• Pacific West Urology
  Las Vegas, Nevada, United States Recruiting
• Feinstein Institutes for Medical Research / Northwell Health
  Syosset, New York, United States Recruiting

Study contacts

• Principal investigator: Bilal Chughtai, MD — Northwell Health
• Study coordinator: Melanie Bonds, MS
• Email: Melanie.Bonds@olympus.com
• Phone: +1-703-851-4615

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating the effects of an anti-inflammatory drug on benign prostatic hyperplasia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.