Post-Market Study to Assess iTind Safety in Comparison to UroLift (MT-08)

July 30, 2026 updated by: Olympus Corporation of the Americas

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Dunfermline, United Kingdom, KY12 0SU
        • Recruiting
        • Queen Margaret Hospital
        • Principal Investigator:
          • Feras Al Jaafari, MD
        • Contact:
      • London, United Kingdom, GU16 7UJ
        • Recruiting
        • Frimley Park Hospital
        • Principal Investigator:
          • Neil Barber, MD
        • Contact:
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk & Norwich University Hospital
        • Principal Investigator:
          • Mark Rochester, MD
        • Contact:
    • Middlesex
      • Isleworth, Middlesex, United Kingdom, TW7 6AF
        • Recruiting
        • Chelsea and Westminster Hospital
        • Contact:
        • Principal Investigator:
          • Samuel Bishara, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Mitchell Humphreys, MD
        • Contact:
      • Tucson, Arizona, United States, 85704
        • Terminated
        • Arizona Urology Specialists
    • California
      • Fresno, California, United States, 93720
        • Recruiting
        • Urology Associates of Central California
        • Principal Investigator:
          • William Schiff, MD
        • Contact:
      • Sacramento, California, United States, 95823
        • Recruiting
        • Golden State Urology
        • Principal Investigator:
          • Prithipal Sethi, MD
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Terminated
        • NorthShore University Health System Research Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • Southeast Louisiana Veterans Health Care System
        • Principal Investigator:
          • Louis Krane, MD
        • Contact:
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Urology
        • Principal Investigator:
          • Spencer Hart, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Recruiting
        • The Urology Center
        • Principal Investigator:
          • Sida Niu, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89121
    • New York
      • Syosset, New York, United States, 11791
        • Recruiting
        • Feinstein Institutes for Medical Research / Northwell Health
        • Principal Investigator:
          • Bilal Chughtai, MD
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The Conrad Pearson Clinic
        • Principal Investigator:
          • Adam Stewart, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Midtown Urology Associates
        • Principal Investigator:
          • Tyler McClintock, MD
        • Contact:
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology
        • Contact:
        • Principal Investigator:
          • Mark Sutton, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • The Urology Place
        • Principal Investigator:
          • Naveen Kella, MD
        • Contact:
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • Recruiting
        • Potomac Urology Center
        • Principal Investigator:
          • Nilay Gandhi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iTind arm
The iTind is a minimally invasive temporary implant
Device: iTind
The iTind is implemented for 5-7 days
Active Comparator: UroLift
The UroLift is a minimally invasive permanent implant
Procedure: UroLift
UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Time Frame: 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
Time Frame: 12 month
Difference in change of IPSS from baseline between iTind and UroLift groups at 12 months
12 month
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
Time Frame: 3 month
Incidence of all intraoperative and post-operative adverse events (AEs) (i.e., related to procedure and/or device) through 3 months post-procedure.
3 month
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
Time Frame: 1, 6, 24, and 36 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 1, 6, 24, and 36 months
1, 6, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
Time Frame: 1, 3, 6, 12, 24, and 36 months
Difference in change of QoL scores (SHIM, MSHQ-EjD, SF-6D) from baseline between iTind and UroLift at 1, 3, 6, 12, 24, and 36 months
1, 3, 6, 12, 24, and 36 months
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months
Time Frame: 1, 3, 6, 12, 18, 24, and 36 months
Difference in rate of re-intervention between iTind and UroLift groups at 1, 3, 6, 12, 18, 24, and 36 months
1, 3, 6, 12, 18, 24, and 36 months
Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months •Overall incidence of procedure and/or device related adverse events
Time Frame: 1, 6, 12, 18, 24, and 36, months

Difference in reporting between iTind and UroLift groups at 1, 6, 12, 18, 24, and 36, months

•Overall incidence of procedure and/or device related adverse events
1, 6, 12, 18, 24, and 36, months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between iTind and UroLift groups for concomitant medication usage
Time Frame: Time frame not specified for exploratory endpoint

Difference between iTind and UroLift groups for the following parameters:

• Concomitant medication usage
Time frame not specified for exploratory endpoint
Difference between iTind and UroLift groups for Anesthesia type
Time Frame: Intraoperative

Difference between iTind and UroLift groups for the following parameters:

• Anesthesia type
Intraoperative
Difference between iTind and UroLift groups for Procedure time
Time Frame: Intraoperative

Difference between iTind and UroLift groups for the following parameters:

• Procedure time
Intraoperative
Difference between iTind and UroLift groups for Hospital length of stay
Time Frame: Post-procedure

Difference between iTind and UroLift groups for the following parameters:

• Hospital length of stay
Post-procedure
Difference between iTind and UroLift groups for Post-operative foley catheterization
Time Frame: Post-procedure

Difference between iTind and UroLift groups for the following parameters:

• Post-operative foley catheterization
Post-procedure
Difference between iTind and UroLift groups for Number of UroLift impants (UroLift arm only)
Time Frame: Intraoperative

Difference between iTind and UroLift groups for the following parameters:

• Number of UroLift impants (UroLift arm only)
Intraoperative
Difference between iTind and UroLift groups for iTind retrieval time (iTind arm only)
Time Frame: Intraoperative

Difference between iTind and UroLift groups for the following parameters:

• iTind retrieval time (iTind arm only)
Intraoperative
Difference between iTind and UroLift groups for iTind post-retrieval foley catheterization (iTind arm only)
Time Frame: Post-procedure

Difference between iTind and UroLift groups for the following parameters:

• iTind post-retrieval foley catheterization (iTind arm only)
Post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Corporation of the Americas

Collaborators

Olympus Europe SE & Co. KG

Investigators

  • Principal Investigator: Neil Barber, MD, Frimley Park Hospital
  • Principal Investigator: Bilal Chughtai, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2022

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

February 7, 2021

First Submitted That Met QC Criteria

February 14, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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