[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549500":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":41,"collaborators":11,"id":43,"slug":11,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":11,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ANI (Analgesia nociception index) will be recorded during the SNM (Sacral neuromodulation).","EXPERIMENTAL",null,[13],"Device: Medical device for SNM: Interstim X or Interstim micro",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Medical device for SNM: Interstim X or Interstim micro","ANI will be used during the SNM (2 hours)",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"DRI","CONTACT","0033320444145","drs-promotion@chu-lille.fr",[27],{"facility":28,"status":29,"city":30,"state":11,"zip":11,"country":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"chu de Lille","RECRUITING","Lille","France",{"type":33,"coordinates":34},"Point",[35,36],3.05512,50.63391,{"lat":36,"lon":35},[39],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":40},"drs.promotion@chu-lille.fr",{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100549500",false,"NCT06434831","Evaluation of Autonomic Nervous System Changes in Response to Stimulation by Sacral Neuromodulation","ESTIME","Inclusion Criteria:\n\n* Male of female ≥ 18 years\n* OAB syndrome\n* Indication for a two-staged SNM\n* Under general anaesthesia with Remifentanil and Propofol\n* Patient who has given written consent to participate in the trial\n* Patient willing to comply with all study procedures and duration\n\nExclusion Criteria:\n\n* Tibial neuro-stimulation (last 3 months)\n* Sacral neuromodulation (last 3 months)\n* Botulinum toxin A intra-detrusor injection (last 9 months)\n* Pregnancy in progress\n* Administrative reasons\n* Guardianship\u002Fcuratorship","ALL","18 Years",{"count":52,"type":53},40,"ESTIMATED","INTERVENTIONAL",[56],"NA","Overactive bladder syndrome (OAB) is defined by urgent and frequent urges to urinate associated with frequent night-time urination and sometimes urinary incontinence. Sacral neuromodulation (SNM) is now one of the second-line treatments for OAB.\n\nThe mode of action of SNM is still poorly understood but a number of data from recent scientific literature suggest that SNM may act, among other things, by altering the balance of the autonomic nervous system (ANS) - located at the interface between the urinary tract and the brain structures regulating the functioning of the urinary tract.\n\nThe aim of this study would therefore be to develop a predictive tool for the effectiveness of SNM.",[59,60],"Bladder Hyperactivity","Sacral Neuromodulation",[62,63,64,65,66],"Bladder hyperactivity","autonomic nervous system","sacral neuromodulation","urodynamic assessment","heart rate variability","2026-04-29",{"date":69,"type":70},"2026-05-06","ACTUAL",{"date":72,"type":70},"2024-02-14",{"date":74,"type":53},"2026-12-02",{"name":5,"class":6},1]