A Randomized, International Study to Assess the Safety of iTind Compared to UroLift (MT-08)

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) Read More

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. 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.
5. 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
6. IPSS ≥ 13 measured at the baseline visit
7. Maximum urinary flow rate (Qmax) of ≤ 12 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 confirmed and should be ruled out to the satisfaction of the PI by MRI and/or biopsy
2. Confirmed or suspected bladder cancer within the last 2 years
3. History of prostatitis within the last 2 years
4. Median lobe obstruction of the prostate as confirmed by TRUS or MRI
5. Screening PSA value > 10 mg/dl
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 and/or 5ARIs
17. Taking anti-platelet or anticoagulants (except low dose aspirin - 81 mg - 100 mg) within the last 7 days
18. Known or suspected allergy to nickel, titanium or polyester/polypropylene