A Randomized, International Study to Assess the Safety of iTind Compared to UroLift

Study Overview
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Brief Summary
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The study objective is to demonstrate the safety of the iTind as compared to the UroLift.

Detailed Description
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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.

Official Title
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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)

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: iTind
* Procedure: UroLift


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Screening PSA < 4 mg/dl* and if performed prior to the Screening/Baseline Visit, the results may be accepted up to 3 months. *Any Screening PSA results that are 4-10 mg/dl must have a negative biopsy performed within 6 months. Prostate volume up to 75 cc (inclusive) documented by TRUS or MRI. The results may be accepted up to 6 months prior to the Screening/Baseline Visit. Imaging performed up to 6 months before enrollment is acceptable if the subject is not on 5ARIs at that time IPSS ≥ 13 measured at the baseline visit Maximum urinary flow rate (Qmax) of ≤ 12 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 Exclusion Criteria: History of prostate cancer or confirmed and should be ruled out to the satisfaction of the PI by MRI and/or biopsy Confirmed or suspected bladder cancer within the last 2 years History of prostatitis within the last 2 years Median lobe obstruction of the prostate as confirmed by TRUS or MRI Screening PSA value > 10 mg/dl 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 Unable to complete the required washout period for alpha blockers and/or 5ARIs Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days Known or suspected allergy to nickel, titanium or polyester/polypropylene

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iTind arm<br>The iTind is a minimally invasive temporary implant | Device: iTind<br>* The iTind is implemented for 5-7 days<br>|
| Experimental: UroLift<br>The UroLift is a minimally invasive permanent implant | Procedure: UroLift<br>* UroLift is a minimally invasive procedure where permanent implants are placed in the prostate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety | The primary safety endpoint of this study is superiority of safety parameters within twelve months, defined by any AEs defined by Clavien Dindo classification system (all grades) | 48 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy | To compare the differences between study groups at each follow-up visit in: Total IPSS: mean/median change from baseline to 3 months | 48 months |