Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

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

Sponsor: Olympus Corporation of the Americas

NCT ID: NCT04757116

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
iTind (device), UroLift (procedure)
How long the study runs
Study runs about 92 months (dates as stated)
About the drug or intervention
iTind — device: The iTind is implemented for 5-7 days · UroLift — procedure: UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years and over
Who
Male
Number of participants
256
Started
2022-09-26
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for benign prostatic hyperplasia (bph)
  • • NA - 256 participants
  • • The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift

Who can take part?

  • • Ages 50 Years and over
  • • Diagnosed with benign prostatic hyperplasia (bph)
  • • Male only

Where?

  • • Isleworth - Chelsea and Westminster Hospital
  • • Dunfermline - Queen Margaret Hospital
  • • London - Frimley Park Hospital
  • • Norwich - Norfolk & Norwich University Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.

More detail

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-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen. This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.

Benign Prostatic Hyperplasia (BPH)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years and over
  • Who can join: Male only

Biomarkers mentioned

PSA

What the study is looking for

  • ✓Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder...
  • ✓Willing and able to provide agreement to take part
  • ✓Males ≥ 50 years of age or older
  • ✓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...
  • ✓Prostate volume up to 75 cc (inclusive) documented by cross-sectional imaging (TRUS, MRI, etc.). Results from...

Who cannot take part

  • ✗History of prostate cancer or suspected, should be ruled out to the satisfaction of the PI by local the usual treatment...
  • ✗Confirmed bladder cancer within the last 2 years or currently suspected bladder cancer
  • ✗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/ml
See the full 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/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 Is This Study? (4 UK sites)

Chelsea and Westminster Hospital

Isleworth TW7 6AF, United Kingdom

Recruiting
Site contact (verified)
Samuel Bishara, MDPrincipal Investigator

Queen Margaret Hospital

Dunfermline KY12 0SU, United Kingdom

Recruiting
Site contact (verified)
Feras Al Jaafari, MDPrincipal Investigator

Frimley Park Hospital

London GU16 7UJ, United Kingdom

Recruiting
Site contact (verified)
Neil Barber, MDPrincipal Investigator
Reynette Baromanr.baroman@nhs.net

Norfolk & Norwich University Hospital

Norwich NR4 7UY, United Kingdom

Recruiting
Site contact (verified)
Mark Rochester, MDPrincipal Investigator

How to Get in Touch

Melanie Bonds, MS

Sponsor contact

CONTACT

+1-703-851-4615 Melanie.Bonds@olympus.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09