A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GT Urological, LLC
- Enrollment
- 80
- Locations
- 10
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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 (
- •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
Arms & Interventions
RELIEF II - GTU AUS
Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU Artificial Urinary Sphincter device in males with stress urinary incontinence.
Intervention: GTU Artificial Urinary Sphincter (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 3 months
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.
Secondary Outcomes
- Secondary Safety Endpoint: Summary of all adverse events(3 months)
- 1-Hour Pad Weight(3 months)
- Primary Safety Endpoint(3 months)
- Quality of Life Assessment(3 months)
- Pad Usage(3 months)