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Temporary implant vs permanent: which is safer for BPH?

NCT ID NCT04757116

Symptom relief Sponsor: Olympus Corporation of the Americas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests the safety of a temporary implant called iTind, placed for 5-7 days, against the permanent UroLift system for men with enlarged prostate symptoms. About 206 men aged 50 and older will be randomly assigned to one treatment. The main goal is to see which causes fewer complications within 3 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
temporarily implanted nitinol device (iTind)
What this could lead to
If successful, this could offer a safer, less invasive option for men with enlarged prostate symptoms, potentially reducing complications compared to permanent implants.
What could go wrong
This is a post-market study, not a cure. The iTind device is temporary but may still cause side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 256 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Benign prostatic hyperplasia (BPH)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Urology Specialists

    TERMINATED

    Tucson, Arizona, 85704, United States

  • Chelsea and Westminster Hospital

    RECRUITING

    Isleworth, Middlesex, TW7 6AF, United Kingdom

  • Feinstein Institutes for Medical Research / Northwell Health

    RECRUITING

    Syosset, New York, 11791, United States

  • Frimley Park Hospital

    RECRUITING

    London, GU16 7UJ, United Kingdom

  • Golden State Urology

    RECRUITING

    Sacramento, California, 95823, United States

  • Houston Metro Urology

    RECRUITING

    Houston, Texas, 77027, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Midtown Urology Associates

    RECRUITING

    Austin, Texas, 78705, United States

  • Minnesota Urology

    RECRUITING

    Woodbury, Minnesota, 55125, United States

  • Norfolk & Norwich University Hospital

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • NorthShore University Health System Research Institute

    TERMINATED

    Evanston, Illinois, 60201, United States

  • Pacific West Urology

    RECRUITING

    Las Vegas, Nevada, 89121, United States

  • Potomac Urology Center

    RECRUITING

    Alexandria, Virginia, 22311, United States

  • Queen Margaret Hospital

    RECRUITING

    Dunfermline, KY12 0SU, United Kingdom

  • Southeast Louisiana Veterans Health Care System

    RECRUITING

    New Orleans, Louisiana, 70119, United States

  • The Conrad Pearson Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • The Urology Center

    RECRUITING

    Omaha, Nebraska, 68124, United States

  • The Urology Place

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Urology Associates of Central California

    RECRUITING

    Fresno, California, 93720, United States

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