Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)
Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)
The purpose of this investigation is to demonstrate the safety and efficacy of the GTU
 artificial urinary sphincter device in restoring continence in males who have confirmed
 urinary stress incontinence for a minimum of 12 months with primary etiology being radical
 prostatectomy or transurethral resection of the prostate (TURP).
Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU
 artificial urinary sphincter device in males with urinary incontinence.

 Up to 20 sites in Europe, Australia & New Zealand

 A sample size of 73 subjects is estimated to provide 80% power for efficacy. Accounting for
 10% attrition, 82 subjects will be enrolled to provide non-missing data on 73 subjects.

 First Subject Enrolment: July 2014 Last Subject Enrolment: September 2015 Last Subject
 Follow-up: September 2016 Study Primary Endpoint Completion: January 2016

 Each subject will be followed for approximately 14 months. Study duration is approximately 27
 months.

 Subjects will be evaluated at the screening, pre-implant, implant, 6 weeks post implant for
 device activation, 1-month, 2-month, 3-month, 6-month, and 12-month post device activation.

 The Sponsor (GT Urological, LLC) will work with a Contract Research Organization (CRO) to
 assist in investigative site monitoring for this clinical investigation.
Inclusion Criteria:

 1. Males > 21 years

 2. Willing/able to sign informed consent

 3. Has undergone radical prostatectomy or transurethral resection of the prostate or
 other prostate surgery prior to 6 months of the time of enrollment

 4. Primary stress urinary incontinence confirmed urodynamically as dominant form of UI

 5. Failed conservative incontinence treatment (see list below) for at least 6 months

 1. Pelvic exercises and bladder training

 2. Drug Therapy

 3. Biofeedback

 4. Electrical stimulation

 5. Behavioral therapy

 6. Subject has severe urinary incontinence defined by:

 a. One 24-hour pad weight test ≥300 gm

 7. Max urethral closure pressure < 30 cm H2O

 8. Bladder capacity > 250 ml

 9. Post void residual urine < 50 ml

 10. Abnormal/poor compliance bladder defined by <30-40cm H2O.

 11. Willing/able to comply with follow-up activities

 12. Is an appropriate surgical candidate as determined by the investigator

 13. Negative urine culture prior to surgery

 14. Cognitive/manual capability to operate device

 Exclusion Criteria:

 1. Subjects considered to be vulnerable

 2. Refuses or unable to sign the informed consent

 3. Cannot comply with study requirements, follow-up visits and tests

 4. Currently enrolled or plans to enroll in another investigational device or drug
 clinical trial or has completed an investigational study within 2 weeks

 5. Estimated life span < 5 years

 6. Recent or planned surgeries within 3 months before or 12 weeks after the implant
 procedure

 7. Primary urge incontinence, mixed incontinence with a predominant urgency component, or
 urinary incontinence due to or complicated by bladder outlet obstruction

 8. Has had implantation of artificial urinary sphincter prosthesis, sling, or other
 urogenital implant

 9. Has had ProACT device explanted and the urethra is compromised as assessed by the
 investigator

 10. Demonstrated bladder outlet obstruction (BOO) as measured by the pressure flow
 cystometry

 11. Neurogenic bladder dysfunction not treatable/controllable by pharmacological or
 alternative methods

 12. Uncontrolled diabetes mellitus defined as persistent blood sugar level recordings of
 >12mmol/l (216. mg/dl) and a glycosylated hemoglobin (HbA1C) of >9% (75mmol/mol) over
 the preceding 3 months

 13. Active abscess or infection

 14. Bladder neck or urethral stricture disease requiring > 2 regular instrumentation or
 dilation proximal to or at the level of the urethral sheath

 15. Bladder cancer or transitional cell carcinoma requiring regular cystoscopy and/or
 rapidly progressive prostatic or testicular cancer

 16. Needs self-intermittent catheterization

 17. Diagnosed disease precluding subject from being able to recall or summarize urinary
 status

 18. Diagnosed disease or medical condition (e.g., Parkinson's) precluding subject from
 being physically capable of manipulating the device

 19. History of bleeding diathesis or cannot stop usage of an anti-coagulant until the
 International Normalized Ratio (INR) is below 1.5 or quick value >70

 20. Uses an indwelling catheter or condom catheter for treatment of incontinence and is
 not willing to discontinue use for study assessments

 21. Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards,
 unless further investigation confirms no signs of local recurrence

 22. Known allergy to device material

 23. Active or recurrent urinary tract infections (UTIs) . Recurrent defined as > 4 times
 over the past year

 24. Urodynamic testing shows significant incontinence caused by factors other than stress
 incontinence

 25. No anatomic abnormalities of the urethra, scrotum or penis judged to prevent
 implantation