Clinical Trials in the UK / NCT04757116
Recruiting
Not applicable
Post-Market Study to Assess iTind Safety in Comparison to UroLift
NCT04757116 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Benign Prostatic Hyperplasia (BPH)
Investigational drug(s) / intervention(s)
iTindUroLift
iTind: The iTind is implemented for 5-7 days
UroLift: UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.
Study summary
The study objective is to evaluate the efficacy and safety of the iTind device compared to UroLift.
Eligibility
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
Primary outcome measure(s)
- Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months — 3 months
Difference in change of IPSS from baseline between iTind and UroLift groups at 3 months
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | Recruiting |
| Arizona Urology Specialists | Tucson | Arizona | Terminated |
| Urology Associates of Central California | Fresno | California | Recruiting |
| Golden State Urology | Sacramento | California | Recruiting |
| NorthShore University Health System Research Institute | Evanston | Illinois | Terminated |
| Southeast Louisiana Veterans Health Care System | New Orleans | Louisiana | Active Not Recruiting |
| Minnesota Urology | Woodbury | Minnesota | Withdrawn |
| The Urology Center | Omaha | Nebraska | Recruiting |
| Pacific West Urology | Las Vegas | Nevada | Recruiting |
| Feinstein Institutes for Medical Research / Northwell Health | Syosset | New York | Recruiting |
| The Conrad Pearson Clinic | Germantown | Tennessee | Recruiting |
| Midtown Urology Associates | Austin | Texas | Recruiting |
| Houston Metro Urology | Houston | Texas | Recruiting |
| The Urology Place | San Antonio | Texas | Recruiting |
| Potomac Urology Center | Alexandria | Virginia | Recruiting |
| Chelsea and Westminster Hospital | Isleworth | Middlesex | Recruiting |
| Queen Margaret Hospital | Dunfermline | United Kingdom | Recruiting |
| Frimley Park Hospital | London | United Kingdom | Recruiting |
| Norfolk & Norwich University Hospital | Norwich | United Kingdom | Recruiting |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04757116 on ClinicalTrials.gov ↗ ← All trials in the UK