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Completed

NCT Number: NCT04114266

Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD

Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universitair Ziekenhuis Gent, Ghent, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participating center is unable to contribute consecutive patients.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Time being incontinence-free

    Time frame: Up to 5 years post surgery

    Time being incontinence-free which is defined as the interval being continent after surgery to the date of incontinence recurrence

  2. ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)

    Time frame: At each of the evaluation points up to 5 years post surgery

    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.

  3. 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

    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.

  4. ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

    Time frame: At each of the evaluation points up to 5 years post surgery

    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.

  5. 24-hour pad tests

    Time frame: At each of the evaluation points up to 5 years post surgery

    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.

  6. Urodynamic parameter Volume at leakage

    Time frame: At baseline, week 12 after surgery

    The change of the Volume at leakage (ml) will be compared with baseline.

  7. Urodynamic parameter Detrusor overactivity

    Time frame: At baseline, week 12 after surgery

    The change of Detrusor overactivity (yes/no) will be compared with baseline.

  8. Urodynamic parameter Maximum detrusor pressure during pressure-flow study

    Time frame: At baseline, week 12 after surgery

    The change of Maximum detrusor pressure during pressure-flow study (cm H20) will be compared with baseline.

  9. Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study

    Time frame: At baseline, week 12 after surgery

    The change of Detrusor pressure at Max flow during pressure-flow study (cm H20) will be compared with baseline.

  10. Urodynamic parameter Maximum urinary flow during pressure-flow study

    Time frame: At baseline, week 12 after surgery

    The change of Maximum urinary flow during pressure-flow study (ml/s) will be compared with baseline.

  11. Urodynamic parameter Maximum cystometric capacity

    Time frame: At baseline, week 12 after surgery

    The change of Maximum cystometric capacity (ml) will be compared with baseline.

  12. Urodynamic parameter Retrograde leak point pressure

    Time frame: At baseline, week 12 after surgery

    The change of Retrograde leak point pressure (cm H20) will be compared with baseline.

  13. Main conclusion of Urodynamic investigations

    Time frame: At baseline, week 12 after surgery

    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.

  14. Maximum free urinary flow

    Time frame: At baseline, week 6, week 12 after surgery

    The change in Maximum free urinary flow (ml/s) will be compared to baseline.

  15. Post void Residual Volume

    Time frame: At baseline, week 6, week 12 after surgery

    The change in Post void Residual Volume (ml) will be compared to baseline.

  16. Number of patients with complications

    Time frame: During surgery and up to 5 years after surgery

    Type of complications, associated symptoms and whether or not a revision was needed will be recorded.

  17. Time being revision-free

    Time frame: Up to 5 years post-surgery

    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

  18. Revision-free rate

    Time frame: At 1, 2, 3, 4, 5 years of Registry follow-up

    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

Sponsors and collaborators

Lead sponsor

European Association of Urology Research Foundation

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)

Acronym: VENUS

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2019
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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