Post-Market Study to Assess iTind Safety in Comparison to UroLift (MT-08)

Olympus

Status: Enrolling

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Procedure: UroLift; Device: iTind

Study type: Interventional

Funder types: Industry

Identifiers

NCT04757116

MT-08

Details and patient eligibility

About

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

Full description

Both iTind and UroLift are minimally invasive treatment options for relieving lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). The iTind device is a temporary, self-expanding nitinol implant that remains in place for 5 to 7 days to reshape the prostatic urethra through localized ischemic pressure and tissue remodeling. In contrast, the UroLift system involves the permanent placement of transprostatic implants that retract the enlarged lateral lobes of the prostate to widen the urethral lumen.

This study is designed to directly compare the safety and effectiveness of the iTind device versus the UroLift system in treating LUTS due to BPH.

Enrollment: 206 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

iTind arm

Experimental group

Description:

The iTind is a minimally invasive temporary implant

Treatment:

Device: iTind

UroLift

Active Comparator group

Description:

The UroLift is a minimally invasive permanent implant

Treatment:

Procedure: UroLift