[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534521":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":34,"overallOfficials":43,"centralContacts":47,"locations":54,"responsibleParty":76,"collaborators":21,"id":78,"slug":21,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":21,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":21,"enrollmentInfo":86,"targetDuration":21,"studyType":89,"phases":21,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":56,"whyStopped":21,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Severity of incontinence as measured using 24-hour pad-weight test (24PWT)","The severity of incontinence will be measured using the 24PWT. The patients will be asked to perform the test three times, and the average weight of the three measurements will be recorded. The change in severity of incontinence as measured by 24PWT will be observed from baseline to the end of observation.","72 hours",[14,18],{"measure":15,"description":16,"timeFrame":17},"Patients-reported outcomes of treatment","The patients-reported outcomes will be measured using the Patient Global Impression of Improvement (PGI-I) index. The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy. The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to beginning treatment on a scale from 1. (Very much better) to 7. (Very much worse).","5 years",{"measure":19,"description":20,"timeFrame":17},"Treatment safety assessment","The safety of treatment will be measured by evaluation of the reported treatment-related complications using the Clavien-Dindo classification. The Clavien-Dindo system is widely used throughout surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"CASE_CONTROL","PROSPECTIVE","This is a non-interventional prospective study. The study will include male patients who underwent the Victo artificial sphincter placement due to severe incontinence.\n\nBefore the procedure, all patients will undergo a standard diagnostic work-up. After the procedure, the patients will be invited for regular visits 3 months after device activation and subsequently every 12 months. In addition to the regular visits, patients will be allowed to contact the study center at any time if their continence worsens enough to require adjustment or if they experience any complications.\n\nThe surgical technique of the Victo artificial sphincter implantation has been described in detail elsewhere.\n\nA non-parametric one-way ANOVA Friedman test will be used to compare the changes of categorical variables from baseline to the end of follow-up. Wilcoxon rank-sum test will be used to assess the change of the non-categorical variables. P-value \\\u003C 0.05 is considered statistically significant and no correction for multiple testing will be applied.","Patients with moderate to severe incontinence due to previous prostate surgery, seeking medical help (implantation of the artificial urinary sphincter)",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"Urinary incontinence due to prostate surgery","Consecutive adult male patients with urinary incontinence due to prostate surgery.",[32,33],"Other: 24-h pad-weight test","Other: Patient Global Impression - Improvement Questionnaire",[35,39],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"24-h pad-weight test","The patients will be asked to perform the 24-h pad-weight test",[29],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":21},"Patient Global Impression - Improvement Questionnaire","The patient-reported outcome, as measured by PGI-I (Patient Global Impression - Improvement Questionnaire)",[29],[44],{"name":45,"affiliation":5,"role":46},"Jan Krhut, prof.,MD, PhD","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Jiří Hynčica","CONTACT","0042059737","2587","jiri.hyncica@fno.cz",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":21,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Ostrava","Moravian-Silesian Region","70852","Czechia",{"type":62,"coordinates":63},"Point",[64,65],18.28204,49.83465,{"lat":65,"lon":64},[68,69,71,74],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},{"name":70,"role":46,"phone":21,"phoneExt":21,"email":21},"Jan Krhut, prof.,MD,PhD",{"name":72,"role":73,"phone":21,"phoneExt":21,"email":21},"Radek Paus Sýkora, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":21,"phoneExt":21,"email":21},"Tomáš Rychlý, MD",{"type":77,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100534521",false,"NCT06239909","Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery","Clinical Outcomes of the Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery - Prospective Follow-up Study","Inclusion Criteria:\n\n* urinary incontinence due to previous prostate surgery\n* primo-implantation of the artificial urinary sphincter\n* subject willing and able to give informed consent\n\nExclusion Criteria:\n\n\\- none","MALE","18 Years",{"count":87,"type":88},150,"ESTIMATED","OBSERVATIONAL","The aim of this prospective academic research study is to evaluate the efficacy and safety of the Victo adjustable artificial sphincter in the treatment of male patients with urinary incontinence due to prostate surgery.",[92],"Urinary Incontinence",[94,95,96,97],"urinary incontinence","artificial urinary sphincter","pad-weight test","quality of life","2024-01-25",{"date":100,"type":101},"2024-02-02","ACTUAL",{"date":103,"type":101},"2018-05-01",{"date":105,"type":88},"2026-12",{"name":5,"class":6},1]