Clinical trial NCT04757116: Post-Market Study to Assess iTind Safety in Comparison 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 206
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: UroLift is a treatment for relieving lower urinary tract symptoms (LUTS) secondary to benign Prostatic Hyperplasia (BPH) as a minimally invasive procedure. This procedure has proven to have high efficacy with regards to improving objective and subjective parameters. The iTind is a minimally invasive temporary device designed to relieve LUTS secondary to BPH. This study is designed to compare the minimally invasive iTind device to UroLift.

Eligibility criteria: 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/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

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 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

Primary outcomes:
measure: Incidence of all intraoperative and post-operative complications
timeFrame: 3 months
Secondary outcomes:
measure: Difference in change from baseline between iTind and UroLift groups in International Prostate Symptom Score (IPSS)
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
measure: Difference in change from baseline between iTind and UroLift groups in Sexual Health Inventory for Men (SHIM)
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
measure: Difference in change from baseline between iTind and UroLift groups in Male Sexual Health Questionnaire for assessing ejaculatory dysfunction (MSHQ-EjD)
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
measure: Difference in change from baseline between iTind and UroLift groups in Short-Form Six-Dimension (SF-6D) v2
timeFrame: 1, 3, 6, 12, 24, 36, 48, and 60 months
measure: Difference in rate of re-intervention between iTind and UroLift groups
timeFrame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
measure: Difference in reporting between iTind and UroLift groups in overall incidence of adverse events.
timeFrame: 1, 3, 6, 12, 18, 24, 36, 48, and 60 months
Other outcomes:
measure: Difference between iTind and UroLift groups for concomitant medication usage
timeFrame: Time frame not specified for exploratory endpoint
measure: Difference between iTind and UroLift groups for Anesthesia type
timeFrame: Intraoperative
measure: Difference between iTind and UroLift groups for Procedure time
timeFrame: Intraoperative
measure: Difference between iTind and UroLift groups for Hospital length of stay
timeFrame: Post-procedure
measure: Difference between iTind and UroLift groups for Post-operative foley catheterization
timeFrame: Post-procedure
measure: Difference between iTind and UroLift groups for Number of UroLift impants (UroLift arm only)
timeFrame: Intraoperative
measure: Difference between iTind and UroLift groups for iTind retrieval time (iTind arm only)
timeFrame: Intraoperative
measure: Difference between iTind and UroLift groups for iTind post-retrieval foley catheterization (iTind arm only)
timeFrame: Post-procedure
Locations:
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Sacramento
country: United States
facility: Golden State Urology
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System Research Institute
state: Illinois
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System
state: Louisiana
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Omaha
country: United States
facility: Adult & Pediatric Urology
state: Nebraska
city: Syosset
country: United States
facility: Feinstein Institutes for Medical Research / Northwell Health
state: New York
city: Syosset
country: United States
facility: The Smith Institute of Urology
state: New York
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Austin
country: United States
facility: Midtown Urology Associates
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology Center
state: Virginia
city: Dunfermline
country: United Kingdom
facility: Queen Margaret Hospital
city: London
country: United Kingdom
facility: Frimley Park Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital
Study officials:
affiliation: Plainview Hospital
name: Bilal Chughtai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Frimley Park Hospital
name: Neil Barber, MD
role: PRINCIPAL_INVESTIGATOR
References: