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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)

Conditions
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Male Stress Urinary Incontinence

Intervention / Treatment
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* Device: GTU Artificial Urinary Sphincter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RELIEF II - GTU AUS<br>Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU Artificial Urinary Sphincter device in males with stress urinary incontinence. | Device: GTU Artificial Urinary Sphincter<br>* A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint: Improvement in pad weight defined as at least 60% improvement in pad weight from baseline to 3-months post device activation as measured by the 24-hour pad weight tests. | The primary efficacy endpoint is improvement in pad weight defined as at least 60% improvement in pad weight from baseline to 3-months post device activation as measured by the 24-hour pad weight tests. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-Hour Pad Weight | Improvement in 1- hour pad weight test results from baseline to 3-month post-device activation visit. | 3 months | 
| Pad Usage | Improvement in number of pads used per day from baseline to 3-month post-device activation as measured by a 3-day voiding diary. | 3 months | 
| Quality of Life Assessment | Improvement in Quality of Life assessments as measured by: Incontinence Quality of Life (IQOL) International Consultation on Incontinence Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) | 3 months | 
| Secondary Safety Endpoint: Summary of all adverse events | Summary of all adverse events | 3 months | 
| Primary Safety Endpoint | The primary safety endpoint is a composite of the following major device-related adverse events and/or outcomes at 3 months post-device activation as reported by the investigational site. The components of this composite safety endpoint are: Infection Erosion Urethral atrophy Device reposition Device revision Device removal | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SUI, incontinence, sphincter