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Comparing the safety of iTind and UroLift for treating BPH

A Post-Market, Prospective, Randomized, Controlled, Multicenter International Study to Assess the Safety of the Temporarily Implanted Nitinol Device (iTind) Compared to the UroLift® System in Subjects With Symptomatic Benign Prostatic Hyperplasia (BPH)

Not applicable Interventional Olympus Corporation of the Americas · NCT04757116

This study is testing whether the iTind device is safer than the UroLift procedure for men over 50 with symptoms from an enlarged prostate.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment206 (estimated)
Ages50 Years and up
SexMale
SponsorOlympus Corporation of the Americas Industry-sponsored
Locations19 sites (Phoenix, Arizona and 18 other locations)
Trial IDNCT04757116 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are males aged 50 and older with lower urinary tract symptoms due to benign prostatic enlargement.

Not a fit: Patients with prostate cancer or those who do not meet the specific eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a safer and more effective treatment option for BPH symptoms.

How similar studies have performed: Other studies have shown success with similar minimally invasive approaches for treating BPH, suggesting potential for positive outcomes in this comparison.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Benign Prostatic Hyperplasia
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.