RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2022-09-26

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04757116

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Selen ZuelbaharOlgun, PhD

CONTACT

+1-650-586-2171

Selen.ZuelbaharOlgun@olympus.com

Lina Ginnetti, MA

CONTACT

+1-617-352-5436

lina.ginnetti@olympus.com

Principal Investigator

Bilal Chughtai, MD

PRINCIPAL_INVESTIGATOR

Plainview Hospital

Neil Barber, MD

PRINCIPAL_INVESTIGATOR

Frimley Park Hospital

Study Locations (Sites)

Arizona Urology Specialists

Tucson, Arizona, 85704

United States

Urology Associates of Central California

Fresno, California, 93720

United States

Golden State Urology

Sacramento, California, 95823

United States

Northwestern University

Chicago, Illinois, 60208

United States

Northwestern University

Chicago, Illinois, 60611

United States

NorthShore University Health System Research Institute

Evanston, Illinois, 60201

United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, 70119

United States

Adult & Pediatric Urology

Omaha, Nebraska, 68124

United States

The Smith Institute of Urology

Syosset, New York, 11791

United States

The Conrad PEarson

Germantown, Tennessee, 38138

United States

The Urology Place

San Antonio, Texas, 78240

United States

Potomac Urology Center

Alexandria, Virginia, 22311

United States

Collaborators and Investigators

Sponsor: Olympus Corporation of the Americas

Bilal Chughtai, MD, PRINCIPAL_INVESTIGATOR, Plainview Hospital
Neil Barber, MD, PRINCIPAL_INVESTIGATOR, Frimley Park Hospital

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 Registration Dates

Study Start Date2022-09-26

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2022-09-26

Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

Benign Prostatic Hyperplasia (BPH)