An observational study in Urinary Incontinence, Urinary Incontinence, Stress and Lower Urinary Tract Symptoms, sponsored by European Association of Urology Research Foundation. Completed at 19 sites in 7 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by European Association of Urology Research Foundation · Observational
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 180 is above the median of 130 across 127 observational studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →European Association of Urology Research Foundation is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Compared within Urinary Incontinence, Stress, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Incontinence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Female patients undergoing AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Participating center is unable to contribute consecutive patients.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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).
Time frame: Up to 5 years post surgery
Time being incontinence-free
Time being incontinence-free which is defined as the interval being continent after surgery to the date of incontinence recurrence
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Detrusor overactivity
The change of Detrusor overactivity (yes/no) will be compared with baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, week 12 after surgery
Urodynamic parameter Maximum cystometric capacity
The change of Maximum cystometric capacity (ml) will be compared with baseline.
Time frame: 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.
Time frame: 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.
Time frame: At baseline, week 12 after surgery
Maximum free urinary flow
The change in Maximum free urinary flow (ml/s) will be compared to baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: At 1, 2, 3, 4, 5 years of Registry follow-up
Plan to share: Undecided — Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry
Ran from Jun 2020 to primary completion in Apr 2026, 70 months.
Of 39 non-industry observational studies under Urinary Incontinence, Stress, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 107. This study's 70 months is above that.
Counting every sponsor, half of 48 studies reached it within 45 months; a quarter within 18 and three quarters within 107.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →
European Association of Urology Research Foundation