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Registry for Patients Undergoing AUS Surgery for Female SUI Due to ISD (VENUS)

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ClinicalTrials.gov Identifier: NCT04114266
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
European Association of Urology Research Foundation

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

Condition or disease Intervention/treatment
Urinary Incontinence Urinary Incontinence, Stress Lower Urinary Tract Symptoms Urination Disorders Urologic Diseases Other: Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114266


Contacts
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Contact: Raymond Schipper, Dr. +31263890677 r.schipper@uroweb.org
Contact: Wim Wtjes, Dr. +31263890677 w.witjes@uroweb.org

Locations
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Belgium
University Hospital Leuven
Leuven, Belgium, 3000
France
University of Rennes, Department of Urology Not yet recruiting
Rennes, France, 35000
Principal Investigator: Benoit Peyronnet, MD         
Sponsors and Collaborators
European Association of Urology Research Foundation
Boston Scientific Corporation
Investigators
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Principal Investigator: Benoit Peyronnet, Dr. Rennes University Hospital

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Responsible Party: European Association of Urology Research Foundation
ClinicalTrials.gov Identifier: NCT04114266     History of Changes
Other Study ID Numbers: EAU-RF 2019-01
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Investigators may share pseudonymised individual data with residents/urologist interested to analyze and publish the results of the registry

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Association of Urology Research Foundation:
Urologic Surgical Procedure
Female
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urologic Diseases
Urinary Incontinence, Stress
Urination Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders