Actively Recruiting
Post-Market Study to Assess iTind Safety in Comparison to UroLift
Led by Olympus Corporation of the Americas · Updated on 2026-05-06
206
Participants Needed
19
Research Sites
483 weeks
Total Duration
On this page
Sponsors
O
Olympus Corporation of the Americas
Lead Sponsor
O
Olympus Europe SE & Co. KG
Collaborating Sponsor
AI-Summary
What this Trial Is About
The study objective is to evaluate the safety of the iTind device comparied to UroLift.
CONDITIONS
Official Title
Post-Market Study to Assess iTind Safety in Comparison to UroLift
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction needing treatment
- Willing and able to provide informed consent
- Male aged 50 years or older
- PSA less than 4 ng/dl or if PSA is 4 to 10 ng/dl, prostate cancer must be ruled out within prior 6 months
- Prostate volume up to 75 cc documented by imaging within prior 6 months if not on 5-alpha reductase inhibitors
- International Prostate Symptom Score (IPSS) of 13 or higher
- Maximum urinary flow rate between 5 and 15 mL/sec with voided volume of 125 mL or more
- Willing and able to complete all study visits including questionnaires at baseline and follow-up
You will not qualify if you...
- History or suspicion of prostate cancer not ruled out within prior 6 months
- Confirmed or suspected bladder cancer within last 2 years
- History of acute bacterial prostatitis within last 2 years
- Median lobe obstruction of the prostate confirmed by imaging
- PSA greater than 10 ng/dl
- Contraindications for iTind or UroLift as determined by investigator
- Neurogenic bladder or sphincter abnormalities due to neurological disorders affecting bladder function
- Clinically significant bladder diverticulum
- Diagnosed urethral stricture, meatal stenosis, bladder neck contracture, rectal disease, artificial urinary sphincter, incompetent sphincter, or urinary incontinence due to sphincter issues
- Prior rectal surgery (except hemorrhoidectomy) or rectal disease that may interfere with treatment
- History of pelvic radiotherapy, radical pelvic surgery, urinary diversion, prostate surgery, balloon dilation, urethral stent implantation, laser prostatectomy, or penile prosthesis
- Active urinary tract infection
- Hematuria or bladder stones within last 3 months
- Prostate volume greater than 75 cc
- Post-void residual volume exceeding 250 mL
- Currently using catheterization or unable to void naturally
- Unable to complete required washout period for alpha blockers
- Use of anti-platelet or anticoagulants (except low dose aspirin 81-100 mg) within 7 days prior to randomization
- Known or suspected allergy to nickel, titanium, or polyester/polypropylene
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Arizona Urology Specialists
Tucson, Arizona, United States, 85704
Terminated
3
Urology Associates of Central California
Fresno, California, United States, 93720
Actively Recruiting
4
Golden State Urology
Sacramento, California, United States, 95823
Actively Recruiting
5
NorthShore University Health System Research Institute
Evanston, Illinois, United States, 60201
Terminated
6
Southeast Louisiana Veterans Health Care System
New Orleans, Louisiana, United States, 70119
Actively Recruiting
7
Minnesota Urology
Woodbury, Minnesota, United States, 55125
Actively Recruiting
8
Adult & Pediatric Urology
Omaha, Nebraska, United States, 68124
Actively Recruiting
9
Pacific West Urology
Las Vegas, Nevada, United States, 89121
Actively Recruiting
10
Feinstein Institutes for Medical Research / Northwell Health
Syosset, New York, United States, 11791
Actively Recruiting
11
The Conrad Pearson Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
12
Midtown Urology Associates
Austin, Texas, United States, 78705
Actively Recruiting
13
Houston Metro Urology
Houston, Texas, United States, 77027
Actively Recruiting
14
The Urology Place
San Antonio, Texas, United States, 78240
Actively Recruiting
15
Potomac Urology Center
Alexandria, Virginia, United States, 22311
Actively Recruiting
16
Chelsea and Westminster Hospital
Isleworth, Middlesex, United Kingdom, TW7 6AF
Actively Recruiting
17
Queen Margaret Hospital
Dunfermline, United Kingdom, KY12 0SU
Actively Recruiting
18
Frimley Park Hospital
London, United Kingdom, GU16 7UJ
Actively Recruiting
19
Norfolk & Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Actively Recruiting
Research Team
S
Selen ZuelbaharOlgun, PhD
CONTACT
L
Lina Ginnetti, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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