Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II) (RELIEFII)

This is an interventional treatment trial for Male Stress Urinary Incontinence focused on measuring SUI, incontinence, sphincter Read More

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