Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)
NCT ID: NCT02288455
Last Updated: 2017-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2014-10-31
2017-11-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
GTU Artificial Urinary Sphincter
A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)
Interventions
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GTU Artificial Urinary Sphincter
A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
MALE
No
Sponsors
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GT Urological, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Haillot
Role: STUDY_DIRECTOR
Hôpitaux de Tours
Locations
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Urology Centre
Port Macquarie, New South Wales, Australia
South Coast Urology
Wollongong, New South Wales, Australia
St George Hospital
Sydney, , Australia
nemocnice Ostrava
Ostrava, , Czechia
Fakultni Thomayerova nemocnice
Prague, , Czechia
Tauranga Urology Research Limited
Tauranga, , New Zealand
Countries
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Other Identifiers
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TP13-101
Identifier Type: -
Identifier Source: org_study_id