Male Stress Urinary IncontinenceRELIEFIINCT02288455
Clinical Investigation of GT UrologIcal, LLC's Artificial Urinary Sphincter (RELIEF II)
A study testing GTU Artificial Urinary Sphincter in people with Male Stress Urinary Incontinence, run by GT Urological, LLC at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Male Stress Urinary Incontinence
- What is being tested?
- GTU Artificial Urinary Sphincter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2014to 20 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Drug Therapy
- Biofeedback
- Electrical stimulation
- Behavioral therapy
- Subject has severe urinary incontinence defined by:
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Australia3 sites
Urology Centre
Port Macquarie, New South Wales, 2424
St George Hospital
Sydney
South Coast Urology
Wollongong, New South Wales, 2525
Czechia2 sites
nemocnice Ostrava
Ostrava, 708 52
Fakultni Thomayerova nemocnice
Prague, 140 59
About this study
Official title: A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)
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).
Read the 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.
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
- Male Stress Urinary Incontinence
- Being tested
- GTU Artificial Urinary Sphincter
- Keywords
- SUI, incontinence, sphincter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTU Artificial Urinary SphincterDevice
A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)
| Study group | Role | What they receive |
|---|---|---|
| RELIEF II - GTU AUS | Experimental | Prospective, non-randomized multi-center study testing the safety and efficacy of the GTU Artificial Urinary Sphincter device in males with stress urinary incontinence. Receives: Device: GTU Artificial Urinary Sphincter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
1-Hour Pad Weight
Improvement in 1- hour pad weight test results from baseline to 3-month post-device activation visit.
Measured: 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.
Measured: 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)
Measured: 3 months
Secondary Safety Endpoint: Summary of all adverse events
Summary of all adverse events
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- GT Urological, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier Haillot, Study director, Hôpitaux de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288455
- Sponsor's protocol ID
- TP13-101
- Acronym
- RELIEFII
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2014
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Multi-Center Clinical Investigation of the Safety and PeRformancE of GT UroLogIcal, LLC's ArtiFicial Urinary Sphincter (RELIEF II)
- ClinicalTrials.gov ID
- NCT02288455
- Acronym / sponsor ID
- RELIEFII / TP13-101
- Conditions
- Male Stress Urinary Incontinence
- Keywords
- SUI, incontinence, sphincter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- GT Urological, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RELIEF II - GTU AUS | Experimental | Device: GTU Artificial Urinary SphincterProspective, non-randomized multi-center study testing the safety and efficacy of the GTU Artificial Urinary Sphincter device in males with stress urinary incontinence. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTU Artificial Urinary SphincterA totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI) | Device | RELIEF II - GTU AUS |
Primary outcome
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.
5 secondary outcomes
1-Hour Pad Weight
Time frame: 3 months
Pad Usage
Time frame: 3 months
Quality of Life Assessment
Time frame: 3 months
Secondary Safety Endpoint: Summary of all adverse events
Time frame: 3 months
Primary Safety Endpoint
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Haillot study director
Hôpitaux de Tours
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTU Artificial Urinary Sphincter in people with Male Stress Urinary Incontinence, run by GT Urological, LLC at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Czechia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.