A Randomized, International Study to Assess the Safety of iTind Compared to TURP
A Randomized, International Study to Assess the Safety of iTind Compared to TURP
The study objective is to demonstrate the safety of the iTind as compared to the TURP arm and
 to further evaluate the efficacy of iTind vs. TURP in terms of subjective and functional
 results.
Transurethral resection of the prostate (TURP) is the gold standard treatment for relieving
 lower urinary tract symptoms (LUTS) secondary to benign Prostatic Hyperplasia (BPH). This
 surgery has proven to have high efficacy with regards to improving objective and subjective
 parameters, however it is associated with significant morbidity, lengthy recovery period and
 long-term complications. 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 TURP.
Inclusion Criteria:

 1. Subject has diagnosis of lower urinary tract symptoms due to benign prostatic
 enlargement causing bladder outlet obstruction

 2. Subject is willing to be randomized

 3. Subject is mentally capable and willing to sign a study-specific informed consent form

 4. Subject is willing and able to comply with all study requirements

 5. Age from 45 through 80 years

 6. Subject has medical record documentation of a prostate volume up to 60mL (inclusive)
 by Transrectal Ultrasound (TRUS) (If TRUS testing documentation is available from less
 than 90 days prior to the informed consent date and the prostate volume is up to 60mL,
 it may be used for the inclusion/exclusion criteria)

 7. Subject has an IPSS urinary symptoms score greater than or equal to 13 measured at the
 baseline visit

 8. Subject has medical record documentation of a maximum urinary flow rate (Qmax) ≤15mL/s
 and ≥5mL/s (If uroflow testing documentation is available within 90 days prior to the
 informed consent date, and the sample is greater than or equal to 120mL, and the Qmax
 is ≤15mL/s and ≥5mL/s, it may be used for the inclusion/exclusion criteria)

 9. Subject has a serum creatinine that is within the normal range for the laboratory at
 the study center (or documentation of clinical insignificance in the subject's medical
 record by the investigator if outside the normal range) and measured ≤ 30 days prior
 to the date of surgery

 10. History of inadequate response, contraindication, or refusal to medical therapy

 11. Blood CBC and biochemistry up to two weeks before screening demonstrating: Normal
 values of the PT, PTT and INR tests

 12. Normal Urinalysis and urine culture

 13. Sexually active within 6 months before the index procedure

 14. Sexual Health Inventory for Men score >6

 15. Positive response to MSHQ-EjD (excluding the response ''Could not ejaculate'')

 16. Incontinence Severity Index score >4.

 Exclusion Criteria:

 1. BMI ≥ 42

 2. History of prostate cancer or current/suspected bladder cancer

 3. Prostate cancer should be ruled out before participation to the satisfaction of the
 investigator if PSA is above acceptable thresholds

 4. Subjects with a history of actively treated bladder cancer within the past two (2)
 years

 5. Neurogenic bladder as confirmed by urodynamics or other neurological disorder that
 affects bladder function

 6. Diagnosis of polyneuropathy

 7. Bladder calculus or clinically significant bladder diverticulum (e.g., pouch size >20%
 of full bladder size)

 8. Active infection, including urinary tract infection

 9. Prostatitis treated with antibiotics within 1 year of enrollment

 10. Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain
 syndrome (e.g. nonbacterial chronic prostatitis)

 11. Ever been diagnosed with a urethral stricture, meatal stenosis, or bladder neck
 contracture

 12. Subject has damage to external urinary sphincter

 13. Subject has diagnosis of stress urinary incontinence that requires treatment or daily
 pad or device use

 14. PVR > 250 mL

 15. Urinary retention at time of enrollment or subject has been catheterized in the 14
 days prior to the surgical procedure

 16. Subject has a history of intermittent self-catheterization

 17. Previous prostate surgery or history of other lower urinary tract surgery such as e.g.
 urinary diversion, artificial urinary sphincter or penile prosthesis

 18. Subjects on anticoagulants (if medication cannot be stopped before and after
 procedure) or known coagulopathy (except aspirin below 100mg/d)

 19. Any severe illness that would prevent complete study participation or confound study
 results

 20. Serious concurrent medical conditions such as heart disease (e.g., myocardial
 infarction within 30 days prior to the date of informed consent, congestive heart
 failure - NYHA IV), pulmonary disease or uncontrolled diabetes

 21. Has had an open heart surgery, or cardiac arrest < 180 days prior to the date of
 informed consent

 22. Heart surgery, or cardiac arrest < 180 days prior to the date of informed consent

 23. Participants using systemic immune-suppressants including corticosteroids; unable to
 withhold non-steroidal anti-inflammatory agents (NSAIDs, including aspirin) for 3-5
 days prior to treatment except for low dose aspirin (e.g. less than or equal to 100mg)

 24. Known illicit substance abuse

 25. Participants using anticholinergics specifically for bladder problems. Use of
 medications with anticholinergic properties is allowable provided the patient does not
 have documented adverse urinary side effects from these medications

 26. Dementia or psychiatric condition that prevents the participant from completing
 required follow up

 27. Contraindication to general or spinal anesthesia

 28. Previous pelvic radiotherapy

 29. Participating in another investigational study that could affect responses to the
 study device

 30. Subject has any other disease or condition(s) that would interfere with completion of
 the study and follow up assessments, would increase risks of the procedure, or in the
 judgment of the investigator would potentially interfere with compliance to this study
 or would adversely affect outcomes

 31. Subject is unwilling to accept a transfusion should one be required

 32. Median lobe obstruction of the prostate as assessed by TRUS

 33. Known allergy to nickel

 34. Unwilling to report sexual function.

 Intraoperative Exclusion Criteria:

 Median lobe obstruction or any abnormal findings on cystoscopy at the time of implantation
 that can interfere with iTind implantation or TURP procedure