Stress Urinary IncontinenceDRYNCT04827199
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
A study testing Artificial Urinary Sphincter implantation in people with Stress Urinary Incontinence, run by Myopowers Medical Technologies France SAS at 3 sites in 2 countries.
Trial summary
This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking. The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Artificial Urinary Sphincter implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2022to Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
- Subject with persistent urinary incontinence, defined as >12 months
- Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 75 grams
- Subject willing and able to provide written informed consent
- Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control
- Subject willing and able to comply with follow-up visits
- Subject having understood and accepted to be unable to proceed to an MRI examination after the surgical procedure due to the non-MRI compatibility of the device
- Subject having signed the informed consent
Who cannot join
- Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
- Subject with history of Artificial Urinary Sphincter or male sling implantation
- Subject with history of pelvic radiotherapy
- Subject with history of Artificial Urinary Sphincter-related urethral erosion
- Subject with history of urethral fistula
- Subject with history of bladder tumour
Show all 28Show fewer
- Subject with severe urethral stenosis
- Subject with urge incontinence due to hyperactive bladder not adequately controlled by drug therapy
- Subject with severe congenital or acquired haemorrhagic disease, haemophilia, or another coagulopathy
- Subject under anti-coagulation or anti-platelet medication that cannot be discontinued at least 5 days prior to surgery and restarted at least 5 days after surgery
- Subject with currently active infection, including urinary tract infection
- Subject with severe renal failure or obstructive pathologies of the upper urinary tract with severe renal failure
- Subject with a current vesicourethral reflux
- Subject with congenital or acquired immunodeficiency, including those who are immunocompromised or immunosuppressed
- Subject with bladder or urethral foreign body or calculus
- Subject with allergy to any components of the device
- Subject deprived of liberty by administrative or judicial decision or under legal guardianship
- Subject having a Body Mass Index (BMI) > 40
- Subject with post void residual volume greater than 200 mL, within the past 6 months
- Subject with uncontrolled diabetes, defined as HbA1c > 9.0%, within the past 6 months
- Subject with history of recurrent bladder stones or history of failed bladder stone treatment within the past 12 months
- Subject currently enrolled or plans to participate in another investigational study of a drug, biologic, or medical device from the point of enrolment through the 12 months post device activation period
- Subject who underwent any surgical procedure in the last 3 months, or with planned surgical procedure within the next 3 months
- Subject who is unwilling or deemed by the Investigator to be unwilling to comply with the Clinical Investigation Plan, or subject with a history of non-compliance
- Subject unable to understand and sign the ICF in absence of legal representative
- Subject with a lack of capacity to consent
- Subject unable to read and write
- Subject in emergency situation
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Spain2 sites
Hospital Germans Trias i Pujol
Barcelona, Badalona, 08916
José Luis Gago, Dr, +34 934 65 12 00, jlgago.germanstrias@gencat.cat
Hospital Clinico San Carlos
Madrid, 28040
Luis RESEL FOLKERSMA, Dr, + 91 330 30 00, urolog.hcsc@salud.madrid.org
About this study
Official title: Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency
This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.
The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:
Read more
- pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),
- pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),
- long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).
The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Artificial Urinary Sphincter implantation
- Keywords
- Artificial Urinary Sphincter
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Urinary Sphincter implantationDevice
Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation)
Implantation procedure which includes:
- Perineal approach and bulbar urethral dissection
- Inguinal approach
- Cuff implantation around the urethra
- Transmission cable passing
- Surgery test procedure
- Implantation of the Control Unit
- Closure of the inguinal incision
- Closure of the perineal incision
- "Implant disabled mode" activation
| Study group | Role | What they receive |
|---|---|---|
| ARTUS® | Experimental | The subjects will be implanted with the experimental medical device ARTUS® Artificial Urinary Sphincter (AUS) during the surgical procedure and will be trained to the use of the Remote Control to control themselves the micturition. Receives: Device: Artificial Urinary Sphincter implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 24-hour Pad Weight Test
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline.
Measured: 3 months post-device activation
Secondary outcomes (23)
Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period
All adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period, with their occurrence, severity and nature.
All adverse events will be analysed and classified using the Clavien-Dindo classification grading system
Measured: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Revision rate
Proportion of subjects who have been concerned with a revision between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period
Measured: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Explantation rate
Proportion of subjects who have been concerned with an explantation of the medical device between the implantation and each visit (or scheduled visit date), until the 10-year follow-up period
Measured: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Renal function
Assessed using the serum creatinine
Measured: Baseline, Implantation, discharge, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Pain assessed by numeric rating scale
Pain assessed using a 10-point numeric rating scale where 0 is no pain and 10 is the worst pain imaginable
Measured: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Voided urine assessed with uroflowmetry
Voided urine assessed with uroflowmetry per unit of time (mL/s)
Measured: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Voided volume assessed with uroflowmetry
Voided volume assessed with uroflowmetry in mL and maximum flow rate (Qmax)
Measured: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Maximum flow rate assessed with uroflowmetry
Maximum flow rate assessed with uroflowmetry (Qmax)
Measured: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Bladder drainage
Assessed using post-void residual volume
Measured: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Usability assessed by a 5-point scale
Usability assessed by a 5-point scale from 1 (strongly agree) to 5 (strongly disagree)
Measured: Implantation
Device deficiencies occurred from the implantation to the 10-year follow-up period
Device deficiencies occurred from the implantation to the 10-year follow-up period with their occurrence and nature.
Measured: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Change in the 24-hour Pad Weight Test
24-hour Pad Weight Test
Measured: Baseline, 3, 6 and 12-month post-device activation
Reduction in the 24-hour Pad Weight Test
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test
Measured: Baseline, 6 and 12-month post-device activation
Pad Usage
Number of pads/day
Measured: Baseline, 3, 6, and 12-month post-device activation visit,2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Urinary symptoms assessed with ICIQ-MLUTS subscales
Urinary symptoms assessed with ICIQ-MLUTS subscales :
- Voiding symptoms subscales from 0 (no symptom) to 20
- Incontincence symptoms subscales from 0 (no symptom) to 24
Measured: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire
Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire score from 19 to 76 with greater values indicating increased impact on quality of life
Measured: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
General Quality of Life assessed with EQ-5D-5L questionnaire
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ)
The MSHQ is a 25-item self-administered questionnaire. It encompasses 3 scales: Erection scale (3 items), Ejaculation scale (7 items), Satisfaction scale (6 items), and 9 additional items addressing sexual activity, time since last sexual encounter, level and changes in sexual activity, and bother associated with sexual dysfunction. Response options consist of dichotomous (Yes/No) scales, as well as 5 and 6- point likert scales.
Scores by dimension:
- Erection scale: 0-15 (higher score =higher sexual functioning)
- Ejaculation scale: 1-35 (higher score =higher sexual functioning)
- Satisfaction scale: 6-30 (higher score =higher level of satisfaction)
Measured: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject usability assessed by a 5-point scale
Subject usability questionnaire completed by the subject from 1 (strongly agree) to 5 (strongly disagree)
Measured: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject satisfaction assessed by the PGI-I
Subject satisfaction assessed by the PGI-I questionnaire which includes a unique 7-point scale to describe how the post-operative condition is now, compared with how it was before the surgery and where 1 = Very much better and 7 = very much worse
Measured: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject satisfaction assessed by 5-point scale
Subject satisfaction assessed by the question "Are you satisfied with the use of ARTUS" with the 5-point scale answers where 1 = strongly agree and 5 = Strongly disagree
Measured: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject recommendation assessed by 5-point scale
Subject recommendation assessed by the question "Would you recommend ARTUS to a friend" with the 5-point scale answers where 1 = strongly agree and 5 = Strongly disagree
Measured: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Investigator usability assessed by a 5-point scale
Investigator usability questionnaire completed by the investigator from 1 (strongly agree) to 5 (strongly disagree)
Measured: Device activation visit (6 weeks post-operative visit), 3 months post-device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study startDec 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- The subjects will be implanted with the ARTUS® medical device and then be followed up for 10 years post-implant, with the primary endpoints measured at 3-month post-device activation visit. As there is no comparator, there is no randomization and no blinding in the study. Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myopowers Medical Technologies France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED, Affluent Medical
- Responsible party
- Sponsor
- Investigators
- Roman Zachoval, Pr, Principal investigator, Thomayerova nemocniceMarion Melot, Study director, Myopowers Medical Technologies France SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827199
- Sponsor's protocol ID
- DRY
- Other IDs
- CIV-CZ-22-01-038768
- Acronym
- DRY
- Status last verified
- Sep 2022
- First submitted
- 9 Mar 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) for the Treatment of Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency
- ClinicalTrials.gov ID
- NCT04827199
- Acronym / sponsor ID
- DRY / DRY
- Conditions
- Stress Urinary Incontinence
- Keywords
- Artificial Urinary Sphincter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Myopowers Medical Technologies France SASIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED, Affluent Medical
- Study start
- Dec 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 1 Apr 2021 (actual)
- 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.
This clinical investigation is designed as an interventional, prospective, non-randomized, open-label, single arm, multicentric and international study for obtaining CE marking.
The study will be the first performed with the ARTUS® medical device aiming to assess safety and performance and will be composed of three phases:
- pilot phase (with safety analysis on the 10 first included subjects in 3 investigational sites),
- pivotal phase (in up to 16 investigational sites with a follow-up until the 12-month post-device activation visit, including an interim analysis at 3-month post-device activation visit on performance and safety),
- long-term phase (with a long-term follow-up until 10 years post implantation in up to 16 investigational sites).
The objectives is to assess safety and clinical performance of the ARTUS® for the treatment of Stress Urinary Incontinence at short and long-term.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects will be implanted with the ARTUS® medical device and then be followed up for 10 years post-implant, with the primary endpoints measured at 3-month post-device activation visit. As there is no comparator, there is no randomization and no blinding in the study. Clinical performance outcomes will be measured for each subject at baseline (before implantation) and post-implantation.
| Arm | Type | Receives |
|---|---|---|
| ARTUS® | Experimental | Device: Artificial Urinary Sphincter implantationThe subjects will be implanted with the experimental medical device ARTUS® Artificial Urinary Sphincter (AUS) during the surgical procedure and will be trained to the use of the Remote Control to control themselves the micturition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male subject between 18 and 80 years (inclusive) of age at the time of consent signature
- Subject with persistent urinary incontinence, defined as >12 months
- Subject with severe Stress Urinary Incontinence, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 75 grams
- Subject willing and able to provide written informed consent
- Subject willing and able to comply with all clinical study requirements, including the ability to independently operate the device remote control
Key exclusion criteria (28 listed)
- Subject with documented neurological bladder or history of neurological disease liable to interfere with urinary symptoms
- Subject with history of Artificial Urinary Sphincter or male sling implantation
- Subject with history of pelvic radiotherapy
- Subject with history of Artificial Urinary Sphincter-related urethral erosion
- Subject with history of urethral fistula
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 |
|---|---|---|
| Artificial Urinary Sphincter implantationDevice preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation) Implantation procedure which includes: * Perineal approach and bulbar urethral dissection * Inguinal approach * Cuff implantation around the urethra * Transmission cable passing * Surgery test procedure * Implantation of the Control Unit * Closure of the inguinal incision * Closure of the perineal incision * "Implant disabled mode" activation | Device | ARTUS® |
Primary outcome
Change in the 24-hour Pad Weight Test
Time frame: 3 months post-device activation
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline.
23 secondary outcomes
Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period
Time frame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Revision rate
Time frame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Explantation rate
Time frame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Renal function
Time frame: Baseline, Implantation, discharge, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Pain assessed by numeric rating scale
Time frame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Voided urine assessed with uroflowmetry
Time frame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Voided volume assessed with uroflowmetry
Time frame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Maximum flow rate assessed with uroflowmetry
Time frame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Bladder drainage
Time frame: Baseline, 3, 6 and 12-month post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Usability assessed by a 5-point scale
Time frame: Implantation
Device deficiencies occurred from the implantation to the 10-year follow-up period
Time frame: Implantation, 6 weeks, 8 weeks and 3 months post-op, 3 months, 6 months, 12 months post-device activation, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Change in the 24-hour Pad Weight Test
Time frame: Baseline, 3, 6 and 12-month post-device activation
Reduction in the 24-hour Pad Weight Test
Time frame: Baseline, 6 and 12-month post-device activation
Pad Usage
Time frame: Baseline, 3, 6, and 12-month post-device activation visit,2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Urinary symptoms assessed with ICIQ-MLUTS subscales
Time frame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire
Time frame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
General Quality of Life assessed with EQ-5D-5L questionnaire
Time frame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ)
Time frame: Baseline, 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject usability assessed by a 5-point scale
Time frame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject satisfaction assessed by the PGI-I
Time frame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject satisfaction assessed by 5-point scale
Time frame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Subject recommendation assessed by 5-point scale
Time frame: 3, 6, and 12-month post-device activation visit, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years post-op
Investigator usability assessed by a 5-point scale
Time frame: Device activation visit (6 weeks post-operative visit), 3 months post-device activation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Roman Zachoval, Pr principal investigator
Thomayerova nemocnice
Marion Melot study director
Myopowers Medical Technologies France SAS
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Urinary Sphincter implantation in people with Stress Urinary Incontinence, run by Myopowers Medical Technologies France SAS at 3 sites in 2 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 8 inclusion and 28 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: opening soon, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Phrakorhnkham (+33 (0)4 42 95 12 20, david.phrakornkham@affluentmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 24-hour Pad Weight Test (time frame: 3 months post-device activation). 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 19 Sep 2022.