Urinary IncontinenceVENUSNCT04114266
Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD
An observational study of Urinary Incontinence and Urinary Incontinence, Stress, run by European Association of Urology Research Foundation at 19 sites in 7 countries.
Trial summary
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
- What is being tested?
- Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)
- How many people
- 180 participants
- Where
- 19 sitesin 7 countries
- Study dates
- 23 Jun 2020to 30 Apr 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients undergoing AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
Who may be able to join
- Patient should be Female and aged over 18 years.
- The patient will undergo an initial AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
- Participant is willing and able to give informed consent for participation in the Registry
- Patient is able to complete the questionnaires.
Who cannot join
- Participating center is unable to contribute consecutive patients.
Trial locations and contacts
19 sites in 7 countries.
19 sites in 7 countries
France11 sites
University Hospital Bordeaux
Bordeaux
CHU de Lille
Lille
CHU de Limoges
Limoges
Hôpital Lyon Sud
Lyon
Hôpital la Conception
Marseille
Clinique urologique CHU de NANTES
Nantes
University Hospital of Nimes
Nîmes
Hôpital de la Pitié-Salpêtrière
Paris
University of Rennes, Department of Urology
Rennes, 35000
CHU Rangueil
Toulouse
CHU Nancy
Vandœuvre-lès-Nancy
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent
University Hospital Leuven
Leuven, 3000
Spain2 sites
Hospital de La Princesa
Madrid
Marqués de Valdecilla University Hospital
Santander
About this study
Official title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency
Read the detailed description
This will be a prospective non-controlled cohort study evaluating the outcomes of artificial urinary sphincter (AUS) implantation surgery (Robot-assisted, Laparoscopic, Open or other) in female patients. The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the Urologists from the European Society of Female \& Functional Urology Section of the European Association of Urology (ESFFU) to all its members along with other surgeons undertaking these procedures. The aim is to recruit a total of 150 patients in 2 years whereafter patients will be followed until the end of Registry which is 5 years after inclusion of the first patient. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long-term collection of the dataset from as many centres as possible.
An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed after 1 year by a nominated steering committee. Thereafter, the evaluations will be performed after every year until end of Registry.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms, Urination Disorders, Urologic Diseases
- Being tested
- Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)
- Keywords
- Urologic Surgical Procedure, Female
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms, Urination Disorders, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)Other
Artificial Urinary Sphincter Surgery (Robot-assisted, Laparoscopic, Open, or other) for Female Stress Urinary Incontinence due to intrinsic sphincter deficiency is according to standard practice. Patients scheduled for this type of surgery will be asked to participate in this Registry.
At baseline and follow-up, the patients will be required to fill in Questionnaires, i.e. ICIQ -Urinary Incontinence - Short Form (ICIQ-UI-SF), ICIQ Female Sexual Matters associated with Lower Urinary Tract Symptoms ( ICIQ-FLUTSsex), ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), Patient Global Impression of Improvement-I (PGI-I) which are commonly used in daily practice to assess urinary incontinence, sexual function and quality of life. During the yearly visits, patients will not be required to come for a clinical visit as the questionnaires and a Follow-up form can be completed by post, e-mail or phone call.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
Cure rate is defined as urinary continence with no pads used or use of 1 light security pad.The cure rate after 5 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each of the AUS implantation surgery procedures (Robot-assisted, Laparoscopic, Open, or other).
Measured: Up to 5 years post surgery
Secondary outcomes (18)
Time being incontinence-free
Time being incontinence-free which is defined as the interval being continent after surgery to the date of incontinence recurrence
Measured: Up to 5 years post surgery
ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)
The ICIQ-UI-SF is a questionnaire evaluating 4 question items (Frequency or urinary incontinence, Amount of leakage, Overall impact of urinary incontinence, Self-diagnostic item) . The score can range from 0 to 25. Mean ICIQ-UI-SF scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-UI-SF score compared to baseline will be calculated.
Measured: At each of the evaluation points up to 5 years post surgery
ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)
The ICIQ-FLUTSsex is a questionnaire evaluating 4 question items (Pain/discomfort because of dry vagina, Impact of urinary symptoms, Pain with sexual intercourse, Urine leakage with sexual intercourse). The score can range from 0 to 54. Mean ICIQ-FLUTSsex scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-FLUTSsex compared to baseline will be calculated.
Measured: At each of the evaluation points up to 5 years post surgery
ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
The ICIQ-LUTSqol is a questionnaire evaluating 20 question items on quality of life in urinary incontinent patients with particular reference to social effects. The score can range from 19-76 overall score with greater values indicating increased impact on quality of life.
Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. Mean ICIQ-LUTSqol scores will be calculated at the indicated time points and numbers /percentages of patients in the different surgery categories. Also change in ICIQ-LUTSqol compared to baseline will be calculated.
Measured: At each of the evaluation points up to 5 years post surgery
24-hour pad tests
The results of the 24-hour pad tests (number of pads, grammes of leakage weight) at each of the evaluation points during follow up. The change of results of the 24-hour pad tests will also be compared with baseline over time.
Measured: At each of the evaluation points up to 5 years post surgery
Urodynamic parameter Volume at leakage
The change of the Volume at leakage (ml) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Detrusor overactivity
The change of Detrusor overactivity (yes/no) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Maximum detrusor pressure during pressure-flow study
The change of Maximum detrusor pressure during pressure-flow study (cm H20) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study
The change of Detrusor pressure at Max flow during pressure-flow study (cm H20) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Maximum urinary flow during pressure-flow study
The change of Maximum urinary flow during pressure-flow study (ml/s) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Maximum cystometric capacity
The change of Maximum cystometric capacity (ml) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Urodynamic parameter Retrograde leak point pressure
The change of Retrograde leak point pressure (cm H20) will be compared with baseline.
Measured: At baseline, week 12 after surgery
Main conclusion of Urodynamic investigations
Main conclusion of Urodynamic investigations (Pure stress incontinence, Pure urgency incontinence, Mixed stress, urgency incontinence) will be compared with baseline.mic investigation (Pure stress incontinence, Pure urgency incontinence, Mixed stress, urgency incontinence).The change of Urodynamic parameters will be compared with baseline.
Measured: At baseline, week 12 after surgery
Maximum free urinary flow
The change in Maximum free urinary flow (ml/s) will be compared to baseline.
Measured: At baseline, week 6, week 12 after surgery
Post void Residual Volume
The change in Post void Residual Volume (ml) will be compared to baseline.
Measured: At baseline, week 6, week 12 after surgery
Number of patients with complications
Type of complications, associated symptoms and whether or not a revision was needed will be recorded.
Measured: During surgery and up to 5 years after surgery
Time being revision-free
The interval from the date of surgery to the date of revision whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device
Measured: Up to 5 years post-surgery
Revision-free rate
The number of patients who are revision-free compared to the total number of patients, whereby revision is defined as any urogenital surgical intervention that is related to the function, placement, or site reaction to the implanted device
Measured: At 1, 2, 3, 4, 5 years of Registry follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start23 Jun 2020
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Benoit Peyronnet, Dr., Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114266
- Sponsor's protocol ID
- EAU-RF 2019-01
- Acronym
- VENUS
- Status last verified
- Jun 2026
- First submitted
- 23 Sep 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)
- ClinicalTrials.gov ID
- NCT04114266
- Acronym / sponsor ID
- VENUS / EAU-RF 2019-01
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms, Urination Disorders, Urologic Diseases
- Keywords
- Urologic Surgical Procedure, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- European Association of Urology Research FoundationUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 3 Oct 2019 (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.
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency
Detailed description
This will be a prospective non-controlled cohort study evaluating the outcomes of artificial urinary sphincter (AUS) implantation surgery (Robot-assisted, Laparoscopic, Open or other) in female patients. The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the Urologists from the European Society of Female \& Functional Urology Section of the European Association of Urology (ESFFU) to all its members along with other surgeons undertaking these procedures. The aim is to recruit a total of 150 patients in 2 years whereafter patients will be followed until the end of Registry which is 5 years after inclusion of the first patient. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long-term collection of the dataset from as many centres as possible.
An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed after 1 year by a nominated steering committee. Thereafter, the evaluations will be performed after every year until end of Registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients undergoing AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
Key inclusion criteria (4 listed)
- Patient should be Female and aged over 18 years.
- The patient will undergo an initial AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
- Participant is willing and able to give informed consent for participation in the Registry
- Patient is able to complete the questionnaires.
Key exclusion criteria (1 listed)
- Participating center is unable to contribute consecutive patients.
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 |
|---|---|---|
| Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)Artificial Urinary Sphincter Surgery (Robot-assisted, Laparoscopic, Open, or other) for Female Stress Urinary Incontinence due to intrinsic sphincter deficiency is according to standard practice. Patients scheduled for this type of surgery will be asked to participate in this Registry. At baseline and follow-up, the patients will be required to fill in Questionnaires, i.e. ICIQ -Urinary Incontinence - Short Form (ICIQ-UI-SF), ICIQ Female Sexual Matters associated with Lower Urinary Tract Symptoms ( ICIQ-FLUTSsex), ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), Patient Global Impression of Improvement-I (PGI-I) which are commonly used in daily practice to assess urinary incontinence, sexual function and quality of life. During the yearly visits, patients will not be required to come for a clinical visit as the questionnaires and a Follow-up form can be completed by post, e-mail or phone call. | Other | – |
Primary outcome
Cure rate
Time frame: Up to 5 years post surgery
Cure rate is defined as urinary continence with no pads used or use of 1 light security pad.The cure rate after 5 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each of the AUS implantation surgery procedures (Robot-assisted, Laparoscopic, Open, or other).
18 secondary outcomes
Time being incontinence-free
Time frame: Up to 5 years post surgery
ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)
Time frame: At each of the evaluation points up to 5 years post surgery
ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)
Time frame: At each of the evaluation points up to 5 years post surgery
ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)
Time frame: At each of the evaluation points up to 5 years post surgery
24-hour pad tests
Time frame: At each of the evaluation points up to 5 years post surgery
Urodynamic parameter Volume at leakage
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Detrusor overactivity
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Maximum detrusor pressure during pressure-flow study
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Maximum urinary flow during pressure-flow study
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Maximum cystometric capacity
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Retrograde leak point pressure
Time frame: At baseline, week 12 after surgery
Main conclusion of Urodynamic investigations
Time frame: At baseline, week 12 after surgery
Maximum free urinary flow
Time frame: At baseline, week 6, week 12 after surgery
Post void Residual Volume
Time frame: At baseline, week 6, week 12 after surgery
Number of patients with complications
Time frame: During surgery and up to 5 years after surgery
Time being revision-free
Time frame: Up to 5 years post-surgery
Revision-free rate
Time frame: At 1, 2, 3, 4, 5 years of Registry follow-up
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 15 Jun 2026.
- EAU Research Foundation WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry
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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.
Benoit Peyronnet, Dr. principal investigator
Rennes University Hospital
19 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence and Urinary Incontinence, Stress, run by European Association of Urology Research Foundation at 19 sites in 7 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 4 inclusion and 1 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Belgium, Spain, Czechia, Germany and 2 more countries. 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?
Cure rate (time frame: Up to 5 years post surgery). 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 15 Jun 2026.