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

NCT04757116 | Recruiting FDA Device

• 1 other identifier: MT-08
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 19

Brief Summary

The study objective is to evaluate the safety of the iTind device comparied to UroLift.

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• Incidence of all intraoperative and post-operative complications

  Incidence of all intraoperative and post-operative complications (i.e., related to procedure and/or device) at 3 months

  3 months

Secondary Outcomes (4)

• Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)

  1, 3, 6, 12, 24, 36, 48, and 60 months

• Difference in change of QoL scores from baseline between iTind and UroLift

  1, 3, 6, 12, 24, 36, 48, and 60 months

• Difference in rate of re-intervention

  1, 3, 6, 12, 18, 24, 36, 48, and 60 months

• Difference in reporting between iTind and UroLift groups

  1, 3, 6, 12, 18, 24, 36, 48, and 60 months

Study Arms (2)

iTind arm

EXPERIMENTAL

The iTind is a minimally invasive temporary implant

Device: iTind

UroLift

ACTIVE COMPARATOR

The UroLift is a minimally invasive permanent implant

Procedure: UroLift

Interventions

iTind DEVICE

The iTind is implemented for 5-7 days

iTind arm

UroLift PROCEDURE

UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.

UroLift

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of lower urinary tract symptoms presumed to be secondary to benign prostatic enlargement causing bladder outlet obstruction for which treatment is recommended
• Willing and able to provide informed consent
• Males ≥ 50 years of age or older
• 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
• 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
• International Prostate Symptom Score (IPSS) ≥ 13
• Maximum urinary flow rate (Qmax) of ≤ 15 mL/sec and ≥ 5 mL/sec (voided volume must be ≥ 125 mL)
• Willing and able to complete all study visits including questionnaires at baseline and at follow-up visits

You may not qualify if:

• 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
• Confirmed or suspected bladder cancer within the last 2 years
• 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/dl, ng/ml
• Contraindicated for iTind or UroLift as determined by the PI
• 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
• Clinically significant bladder diverticulum
• Diagnosed with urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, urinary incontinence due to incompetent sphincter
• 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
• An active urinary tract infection
• Hematuria or cystolithiasis within the last 3 months
• Prostate volume \> 75 cc
• Post-void residual volume (PVR) \> 250 mL
• Actively using catheterization or unable to void naturally

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead
• Olympus Europe SE & Co. KG: collaborator

Study Sites (19)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Arizona Urology Specialists

Tucson, Arizona, 85704, United States

TERMINATED

Urology Associates of Central California

Fresno, California, 93720, United States

RECRUITING

Golden State Urology

Sacramento, California, 95823, United States

RECRUITING

NorthShore University Health System Research Institute

Evanston, Illinois, 60201, United States

TERMINATED

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70119, United States

RECRUITING

Minnesota Urology

Woodbury, Minnesota, 55125, United States

RECRUITING

Adult & Pediatric Urology

Omaha, Nebraska, 68124, United States

RECRUITING

Pacific West Urology

Las Vegas, Nevada, 89121, United States

RECRUITING

Feinstein Institutes for Medical Research / Northwell Health

Syosset, New York, 11791, United States

RECRUITING

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Midtown Urology Associates

Austin, Texas, 78705, United States

RECRUITING

Houston Metro Urology

Houston, Texas, 77027, United States

RECRUITING

The Urology Place

San Antonio, Texas, 78240, United States

RECRUITING

Potomac Urology Center

Alexandria, Virginia, 22311, United States

RECRUITING

Chelsea and Westminster Hospital

Isleworth, Middlesex, TW7 6AF, United Kingdom

RECRUITING

Queen Margaret Hospital

Dunfermline, KY12 0SU, United Kingdom

RECRUITING

Frimley Park Hospital

London, GU16 7UJ, United Kingdom

RECRUITING

Norfolk & Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bilal Chughtai, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Neil Barber, MD

  Frimley Park Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selen ZuelbaharOlgun, PhD

CONTACT

+1-650-586-2171; Selen.ZuelbaharOlgun@olympus.com

Lina Ginnetti, MA

CONTACT

+1-617-352-5436; lina.ginnetti@olympus.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2021
• First Posted: February 17, 2021
• Study Start: September 26, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); GB (4)