Back to resultsSafety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS) (DRY)
Primary Purpose
Stress Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Artificial Urinary Sphincter implantation
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Artificial Urinary Sphincter
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Thomayer hospital
- Hospital Germans Trias i Pujol
- Hospital Clinico San Carlos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARTUS®
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Renal function
Assessed using the serum creatinine
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
Voided urine assessed with uroflowmetry
Voided urine assessed with uroflowmetry per unit of time (mL/s)
Voided volume assessed with uroflowmetry
Voided volume assessed with uroflowmetry in mL and maximum flow rate (Qmax)
Maximum flow rate assessed with uroflowmetry
Maximum flow rate assessed with uroflowmetry (Qmax)
Bladder drainage
Assessed using post-void residual volume
Usability assessed by a 5-point scale
Usability assessed by a 5-point scale from 1 (strongly agree) to 5 (strongly disagree)
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.
Change in the 24-hour Pad Weight Test
24-hour Pad Weight Test
Reduction in the 24-hour Pad Weight Test
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test
Pad Usage
Number of pads/day
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
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
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.
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)
Subject usability assessed by a 5-point scale
Subject usability questionnaire completed by the subject from 1 (strongly agree) to 5 (strongly disagree)
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
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
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
Investigator usability assessed by a 5-point scale
Investigator usability questionnaire completed by the investigator from 1 (strongly agree) to 5 (strongly disagree)
Full Information
NCT ID
NCT04827199
First Posted
March 9, 2021
Last Updated
September 14, 2022
Sponsor
Myopowers Medical Technologies France SAS
Collaborators
EVAMED, Affluent Medical
1. Study Identification
Unique Protocol Identification Number
NCT04827199
Brief Title
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
Acronym
DRY
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myopowers Medical Technologies France SAS
Collaborators
EVAMED, Affluent Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Artificial Urinary Sphincter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ARTUS®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Artificial Urinary Sphincter implantation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in the 24-hour Pad Weight Test
Description
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test at 3 months post-device activation compared to baseline.
Time Frame
3 months post-device activation
Secondary Outcome Measure Information:
Title
Adverse events (including adverse device effect) occurred from the implantation to the 10-year follow-up period
Description
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
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
Title
Revision rate
Description
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
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
Title
Explantation rate
Description
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
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
Title
Renal function
Description
Assessed using the serum creatinine
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
Title
Pain assessed by numeric rating scale
Description
Pain assessed using a 10-point numeric rating scale where 0 is no pain and 10 is the worst pain imaginable
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
Title
Voided urine assessed with uroflowmetry
Description
Voided urine assessed with uroflowmetry per unit of time (mL/s)
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
Title
Voided volume assessed with uroflowmetry
Description
Voided volume assessed with uroflowmetry in mL and maximum flow rate (Qmax)
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
Title
Maximum flow rate assessed with uroflowmetry
Description
Maximum flow rate assessed with uroflowmetry (Qmax)
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
Title
Bladder drainage
Description
Assessed using post-void residual volume
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
Title
Usability assessed by a 5-point scale
Description
Usability assessed by a 5-point scale from 1 (strongly agree) to 5 (strongly disagree)
Time Frame
Implantation
Title
Device deficiencies occurred from the implantation to the 10-year follow-up period
Description
Device deficiencies occurred from the implantation to the 10-year follow-up period with their occurrence and nature.
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
Title
Change in the 24-hour Pad Weight Test
Description
24-hour Pad Weight Test
Time Frame
Baseline, 3, 6 and 12-month post-device activation
Title
Reduction in the 24-hour Pad Weight Test
Description
Proportion of subjects with at least 50% reduction in 24-hour Pad Weight Test
Time Frame
Baseline, 6 and 12-month post-device activation
Title
Pad Usage
Description
Number of pads/day
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
Title
Urinary symptoms assessed with ICIQ-MLUTS subscales
Description
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
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
Title
Urinary incontinence Quality of Life assessed with ICIQ-LUTSQoL questionnaire
Description
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
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
Title
General Quality of Life assessed with EQ-5D-5L questionnaire
Description
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.
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
Title
Sexual Quality of Life assessed with the Male Sexual Health Questionnaire (MHSQ)
Description
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)
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
Title
Subject usability assessed by a 5-point scale
Description
Subject usability questionnaire completed by the subject from 1 (strongly agree) to 5 (strongly disagree)
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
Title
Subject satisfaction assessed by the PGI-I
Description
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
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
Title
Subject satisfaction assessed by 5-point scale
Description
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
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
Title
Subject recommendation assessed by 5-point scale
Description
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
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
Title
Investigator usability assessed by a 5-point scale
Description
Investigator usability questionnaire completed by the investigator from 1 (strongly agree) to 5 (strongly disagree)
Time Frame
Device activation visit (6 weeks post-operative visit), 3 months post-device activation
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Phrakorhnkham
Phone
+33 (0)4 42 95 12 20
Email
david.phrakornkham@affluentmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Claire Thieulin
Phone
+33 (0)2 31 93 21 18
Email
anne-claire.thieulin@evamed.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Zachoval, Pr
Organizational Affiliation
Thomayerova nemocnice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marion Melot
Organizational Affiliation
Myopowers Medical Technologies France SAS
Official's Role
Study Director
Facility Information:
Facility Name
Thomayer hospital
City
Prague
Country
Czechia
Facility Name
Hospital Germans Trias i Pujol
City
Barcelona
State/Province
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis Gago, Dr
Phone
+34 934 65 12 00
Email
jlgago.germanstrias@gencat.cat
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis RESEL FOLKERSMA, Dr
Phone
+ 91 330 30 00
Email
urolog.hcsc@salud.madrid.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
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