[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609270":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":58,"collaborators":20,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":20,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":84,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital Ostrava","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacral neuromodulation","EXPERIMENTAL","Female patients with double incontinence (DI) will be enrolled into this study group. The study subjects will undergo sacral neurostimulation (SNM).",[13],"Procedure: Sacral neurostimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Sacral neurostimulation","Sacral neurostimulation (SNS), or sacral neuromodulation (SNM), is a minimally invasive, reversible treatment for bladder and bowel control problems, including overactive bladder and fecal incontinence.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Milan Tesař, MD, Ph.D.","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Jiří Hynčica","CONTACT","0042059737","2587","jiri.hyncica@fno.cz",[33],{"facility":5,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":20,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ostrava","Moravian-Silesian Region","708 52","Czechia",{"type":39,"coordinates":40},"Point",[41,42],18.28204,49.83465,{"lat":42,"lon":41},[45,48,49,52,54,56],{"name":23,"role":28,"phone":29,"phoneExt":46,"email":47},"5707","milan.tesar@fno.cz",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Jan Krhut, prof., MD, Ph.D.","SUB_INVESTIGATOR",{"name":53,"role":51,"phone":20,"phoneExt":20,"email":20},"Ivana Mrázková, MD",{"name":55,"role":51,"phone":20,"phoneExt":20,"email":20},"Radek Paus Sýkora, MD",{"name":57,"role":51,"phone":20,"phoneExt":20,"email":20},"Tomáš Rychlý, MD",{"type":59,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100609270","sacral-neuromodulation-in-patients-with-double-incontinence-100609270",false,"NCT07212387","Sacral Neuromodulation in Patients With Double Incontinence","Effectiveness of Sacral Neuromodulation in Patients With Coexisting Faecal and Urinary Incontinence (\"Double Incontinence\")","Inclusion Criteria:\n\n* Adult women over 18 years of age\n* Consent to participate in the study\n* Willingness to undergo examination, treatment and follow-up according to the protocol\n* DI symptoms characterized by:\n* Grade III fecal incontinence (patient is unable to consciously hold in wind, loose or hard stools)\n* At least 2 episodes of fecal incontinence during the week (according to bladder and bowel diary)\n* At least 1 episode of involuntary urine leakage per day (according to bladder and bowel diary)\n* Total score of the ICIQ-UI SF questionnaire\n* DI symptoms for more than 6 months\n* Failure of previous conservative treatment\n\nExclusion Criteria:\n\n* Rapidly progressing neurological diseases\n* Known severe congenital malformations of the anorectum and\u002For lower urinary tract\n* Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent\n* Pregnancy, lactation\n* Active urinary tract infection\n* Active malignant disease\n* Clinically significant pelvic organ prolapse\n* Active inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n* In the case of an associated lesion of the external anal sphincter, a defect greater than 90 degrees\n* Previous pelvic radiotherapy less than 12 months prior to study enrolment\n* Previous pelvic organ descent surgery less than 12 months prior to study enrolment\n* Previous stress urinary incontinence surgery less than 12 months prior to study enrolment\n* Previous childbirth less than 12 months prior to study enrollment\n* Anatomical malformations of the sacrum that preclude implantation of the SNM electrode\n* Low patient compliance\n* Inability to control the neurostimulator","FEMALE","18 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","This is a prospective study evaluating the effect of a treatment method of sacral neuromodulation (SNM), the use of which is approved and recommended for the treatment of both faecal incontinence (FI) and urinary incontinence (UI). A new aspect of the study is monitoring the effect of SNM in patients with both types of incontinence (faecal and urinary) occurring simultaneously. The study will use diagnostic methods and procedures that are part of the usual examination algorithm. The study will not impose any burden on patients beyond the scope of routine examination and treatment procedures.",[77,78,79],"Double Incontinence","Faecal Incontinence","Urinary Incontinence",[81,82,83,17],"Double incontinence","Faecal incontinence","Urinary incontinence","NOT_YET_RECRUITING","2025-09-30",{"date":87,"type":88},"2025-10-08","ACTUAL",{"date":90,"type":71},"2025-11",{"date":92,"type":71},"2029-12",{"name":5,"class":6},1]