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

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

• Males > 21 years
• Willing/able to sign informed consent
• Has undergone radical prostatectomy or transurethral resection of the prostate or other prostate surgery prior to 6 months of the time of enrollment
• Primary stress urinary incontinence confirmed urodynamically as dominant form of UI
• Failed conservative incontinence treatment (see list below) for at least 6 months

• Pelvic exercises and bladder training
• Drug Therapy
• Biofeedback
• Electrical stimulation
• Behavioral therapy
• Subject has severe urinary incontinence defined by:

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

• Max urethral closure pressure < 30 cm H2O
• Bladder capacity > 250 ml
• Post void residual urine < 50 ml
• Abnormal/poor compliance bladder defined by <30-40cm H2O.
• Willing/able to comply with follow-up activities
• Is an appropriate surgical candidate as determined by the investigator
• Negative urine culture prior to surgery
• Cognitive/manual capability to operate device

Exclusion criteria

• Subjects considered to be vulnerable
• Refuses or unable to sign the informed consent
• Cannot comply with study requirements, follow-up visits and tests
• Currently enrolled or plans to enroll in another investigational device or drug clinical trial or has completed an investigational study within 2 weeks
• Estimated life span < 5 years
• Recent or planned surgeries within 3 months before or 12 weeks after the implant procedure
• Primary urge incontinence, mixed incontinence with a predominant urgency component, or urinary incontinence due to or complicated by bladder outlet obstruction
• Has had implantation of artificial urinary sphincter prosthesis, sling, or other urogenital implant
• Has had ProACT device explanted and the urethra is compromised as assessed by the investigator
• Demonstrated bladder outlet obstruction (BOO) as measured by the pressure flow cystometry
• Neurogenic bladder dysfunction not treatable/controllable by pharmacological or alternative methods
• 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
• Active abscess or infection
• Bladder neck or urethral stricture disease requiring > 2 regular instrumentation or dilation proximal to or at the level of the urethral sheath
• Bladder cancer or transitional cell carcinoma requiring regular cystoscopy and/or rapidly progressive prostatic or testicular cancer
• Needs self-intermittent catheterization
• Diagnosed disease precluding subject from being able to recall or summarize urinary status
• Diagnosed disease or medical condition (e.g., Parkinson's) precluding subject from being physically capable of manipulating the device
• 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
• Uses an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use for study assessments
• Abnormal Prostate Screening Antigen (PSA), according to site's laboratory standards, unless further investigation confirms no signs of local recurrence
• Known allergy to device material
• Active or recurrent urinary tract infections (UTIs) . Recurrent defined as > 4 times over the past year
• Urodynamic testing shows significant incontinence caused by factors other than stress incontinence
• No anatomic abnormalities of the urethra, scrotum or penis judged to prevent implantation