[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fecal-incontinence-fi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fecal-incontinence-fi":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,59,92,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171",false,"NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"NA","Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[26,27,28,29],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[31,32,33],"Peripheral nerve evaluation","External trial system","Pilot study","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-04-30",{"date":42,"type":20},"2026-12",{"name":44,"class":45},"Axonics, Inc.","INDUSTRY",2,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":24,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":46},"100618735",{"count":19,"type":20},[23],[26,27,28,29],[31,32,33],"2026-06-11",{"date":55,"type":38},"2026-06-15",{"date":40,"type":38},{"date":42,"type":20},{"name":44,"class":45},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":46},"100643035","efficacy-and-safety-of-transcutaneous-posterior-tibial-nerve-stimulation-on-fecal-continence-in-patients-undergoing-surgery-for-rectal-neoplasia-100643035","NCT07632196","Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia","Randomized Clinical Trial Assessing the Efficacy and Safety of Transcutaneous Posterior Tibial Nerve Stimulation on Fecal Continence in Patients Undergoing Surgery for Rectal Neoplasia","Inclusion Criteria:\n\n\\- Adult patients diagnosed with rectal neoplasia and who have undergone a high anterior rectal resection regardless of the surgical approach (open, laparoscopic, laparoscopic+TaTME or robotic+TaTME).\n\nExclusion Criteria:\n\n* Patients not operated or within active surveillance strategy programs (watch \\& wait)\n* Patients with ostomy\n* Patients with contraindications to the use of the neurostimulator:\n\n  * Pacemaker \u002F Defibrillator \u002F Other electronic devices\n  * History of heart problems\n  * Propensity to excessive bleeding (coagulopathies)\n  * Damage to the nervous system (epilepsy)\n  * Current pregnancy\n  * Infections or skin lesions\n  * Severe vascular disorders\n  * Active neoplasms.",{"count":67,"type":20},84,[23],"Rectal neoplasia is one of the most prevalent cancers in Spain, and the treatment of choice is total mesorectal excision (TME), as it has demonstrated significant oncological improvements. However, mesorectal excision is not without complications, and patients often experience altered bowel function in the form of low anterior resection syndrome (LARS), as well as erectile dysfunction. However, few studies evaluate faecal incontinence, as most focus on oncological outcomes.\n\nThe aim of our study is to evaluate the efficacy and safety of posterior tibial nerve stimulation on fecal incontinence, sexual dysfunction, and quality of life in patients who underwent to rectal surgery for rectal neoplasia.\n\nIt will be conducted a randomized clinical trial (1:1) with two arms: half of the patients will receive posterior tibial nerve stimulation, while the other half will undergo stimulation with subtherapeutic doses. Faecal incontinence will be assessed using the LARS and Wexner questionnaires, and quality of life and sexual function will be assessed using the Fecal Incontinence Quality of Life Scale (FIQLS) and the Colorectal Cancer Quality of Life Questionnaire (QLQ-CR38), at one month, six months and one year after surgery.",[71,72,73,28,74],"Low Anterior Resection Syndrome (LARS)","Rectal Neoplasm Malignant","Quality of Life (QOL)","Disorder of Ejaculation",[76,77,78,79,80,81,28],"total mesorectum excision","rectal neoplasm","randomised clinical trial","posterior tibial nerve stimulation","low anterior resection syndrome (LARS)","life quality","2026-06-02",{"date":84,"type":38},"2026-06-08",{"date":86,"type":38},"2026-02-06",{"date":88,"type":20},"2028-12-31",{"name":90,"class":91},"Althaia Xarxa Assistencial Universitària de Manresa","OTHER",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100621119","effectiveness-of-electrical-stimulation-and-biofeedback-on-fecal-incontinence-in-children-with-repaired-anorectal-malformation-100621119","NCT07366476","Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation","Effectiveness of Electrical Stimulation and Biofeedback on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Comparative Randomized Clinical Trial","Inclusion Criteria:\n\n* children with repaired anorectal malformation\n* evident spared anal sphincter muscles by MRI\n* the age range from 6 to 10 years\n* able to follow instructions\n* Faecal symptoms will be evaluated for a month to confirm study eligibility.\n\nExclusion Criteria:\n\n* children with absent anal sphincter muscles by MRI\n* children with post-colon surgery other than ARM\n* neurologic\u002Fneuropathic disorder\n* sensory or hearing deficits\n* psychological disturbances.","6 Years","10 Years",{"count":102,"type":20},30,[23],"This study aimed to investigate and compare the effect of electrical stimulation and biofeedback with electrical stimulation alone on fecal incontinence in children with repaired imperforate anus, with ages from 6 to 10 years.",[28,106],"Anorectal Malformations",[108,109,110,111,112],"fecal incontinence","anorectal malformation","biofeedback","anal electrical stimulation","pelvic floor muscles training","NOT_YET_RECRUITING","2026-05-05",{"date":116,"type":38},"2026-05-06",{"date":118,"type":20},"2026-05-01",{"date":120,"type":20},"2026-11-01",{"name":122,"class":91},"Sinai University",1,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":123},"100626518","safety-and-feasibility-evaluation-of-alviv-laser-based-treatment-for-fecal-incontinence-100626518","NCT07436676","Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence","Inclusion Criteria:\n\n* Onset of symptoms for uncontrolled passage of fecal material for at least 6 months prior to enrollment.\n* At least 2-4 staining, solid or liquid FI episodes in the 4 weeks prior to enrollment\n* Documented normal colonoscopy in the last 3 years\n* Normal sigmoidoscopy as part of screening\n* Signed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Rectal prolapse grade ≥ III\n* Hemorrhoids Grade ≥ II.\n* Obstetrical injuries including third- and fourth-degree tears in the anal sphincter within the past 6 months\n* Internal anal sphincter separation \\>270 degrees on Transrectal Ultrasound (TRUS).\n* Congenital malformation of anus or rectum\n* History of pelvic surgery in the past 6 months.\n* inflammatory bowel disease.\n* Presence of Intestinal stoma\n* History of pelvic radiation within the previous 12 months or presence of active radiation proctitis.\n* Presence of existing implant in the anal or rectal region.\n* Active anal or rectal conditions in the last 6 months\n* Abnormal blood coagulation\n* Patients currently receiving immunotherapy or chemotherapy.",{"count":131,"type":20},12,[23],"The purpose if this interventional First in Human study is to assess the Safety and Performance of the ALVIV System laser based treatment in patients diagnosed with Fecal Incontinence.\n\nEligible patients will go through screening assessments, followed by a series of 4-6 treatments with 3 weeks apart. Last follow up visit to the study will occur 3 weeks after last treatment day.\n\nParticipants will be asked to maintain a diary of their fecal incontinence episodes, and complete quality of life and satisfaction questionnaires throughout the study.",[28],"2026-02-26",{"date":137,"type":38},"2026-02-27",{"date":139,"type":38},"2024-04-03",{"date":141,"type":20},"2026-03",{"name":143,"class":45},"Alviv Ltd."]