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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02288455




Registration number
NCT02288455
Ethics application status
Date submitted
6/11/2014
Date registered
11/11/2014
Date last updated
22/11/2017

Titles & IDs
Public title
Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)
Scientific title
A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)
Secondary ID [1] 0 0
TP13-101
Universal Trial Number (UTN)
Trial acronym
RELIEFII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Stress Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - GTU Artificial Urinary Sphincter

Experimental: 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.


Treatment: Devices: GTU Artificial Urinary Sphincter
A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
1-Hour Pad Weight
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Pad Usage
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Quality of Life Assessment
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Secondary Safety Endpoint: Summary of all adverse events
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Primary Safety Endpoint
Timepoint [5] 0 0
3 months

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/11/2017
Sample size
Target
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Urology Centre - Port Macquarie
Recruitment hospital [2] 0 0
South Coast Urology - Wollongong
Recruitment hospital [3] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2424 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2525 - Wollongong
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Ostrava
Country [2] 0 0
Czechia
State/province [2] 0 0
Prague
Country [3] 0 0
New Zealand
State/province [3] 0 0
Tauranga

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GT Urological, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT02288455
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Olivier Haillot
Address 0 0
Hôpitaux de Tours
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02288455