[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"faecal-incontinence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:faecal-incontinence":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,71,94,125,147,174],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637029","understanding-and-tailored-treatment-of-low-anterior-resection-syndrome-100637029",false,"NCT07573371","Understanding and Tailored Treatment of Low Anterior Resection Syndrome","PATO-LARS","Inclusion Criteria:\n\nGeneral:\n\n* Must be able to read and understand Danish.\n* All participants must be adults and \\>18 years and have full legal capacity.\n* Assessed by study personnel to have understood the research protocol, being able to comply with investigation procedures as well as ability to come to the hospital at the agreed timepoints, and to complete the trial.\n\nSpecific inclusion criteria for LARS patients:\n\n* Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postop.\n* If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postop.\n\nSpecific inclusion criteria for fecal incontinence patients and urge fecal incontinence patients\n\n* Patients planned for neuromodulation.\n* Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation.\n\nSpecific inclusion criteria for \"watch and wait\" patients:\n\n• Rectum\u002Fcolon cancer patients treated with organ-preserving treatment, i.e., chemotherapy and radiotherapy with a complete clinical and radiological response at a minimum of 12 months posttreatment.\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n* Persons that are not able to understand information\n* Connective tissue disorders\n* Parkinson's disease\n* Non-MRI compatible pacemaker, clips or other metal objects in the body. Patients implanted with a pacemaker for sacral nerve modulation will not undergo MRI postoperatively.\n* Piercings that cannot be removed before MRI\n* Claustrophobia\n* Allergic to latex\n* Abdominal diameter equal or more than 140 cm\n* Have other individual factors, in the opinion of the physician\u002Fhealthcare professional, in which participating is contraindicated\n* Participation in concomitant clinical trial\n* Known intestinal obstruction, significant intestinal strictures or perforation. If in doubt about intestinal stricture, the patient will be examined with MRI of the small intestine, colonoscopy or other supplementing examination\n* Disorders of swallowing\n* Pregnant women\n\nSpecific exclusion criterias for LARS patients\n\n* History of anastomotic leakage following rectal resection and sphincter preserving therapy\n* Evidens of local recurrence or dessimination of the cancer","ALL","18 Years",{"count":19,"type":20},145,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn why some patients develop low anterior resection syndrome (LARS) after colorectal cancer treatment. The study also aims to identify different subtypes of LARS and understand which patients may respond to specific treatments.\n\nThe main questions it aims to answer are:\n\n* What physiological and imaging changes are associated with LARS?\n* How do patients with LARS differ from patients without LARS after colorectal cancer surgery?\n* Are there measurable differences between LARS, patients treated with organ-preserving chemoradiotherapy, and patients with fecal incontinence?\n\nParticipants will:\n\n* Complete advanced physiological and imaging assessments related to bowel function\n* Be compared with four control groups:\n\n  * patients without LARS after colorectal cancer surgery\n  * patients treated with organ-preserving chemoradiotherapy\n  * patients with fecal incontinence and urge fecal incontinence\n* Take part in a single study visit where all measurements are performed",[24,25,26,27],"Low Anterior Resection Syndrome","Faecal Incontinence With Faecal Urgency","Faecal Incontinence","Colorectal (Colon or Rectal) Cancer Survivors",[29],"LARS","RECRUITING","2026-05-01",{"date":33,"type":34},"2026-05-07","ACTUAL",{"date":36,"type":34},"2024-09-17",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"Aalborg University Hospital","OTHER",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100602654","peristeen-light-explorative-clinical-investigation-100602654","NCT07126327","Peristeen Light Explorative Clinical Investigation","An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light","Inclusion Criteria:\n\n* Has given written informed consent\n* Is at least 18 years old\n* Has full legal capacity\n* Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration\n* Has access to and is able to use a smartphone\n* Has constipation and\u002For faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction\u002Fblockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and\u002For stool)\n* Is assessed (by investigator) to have a need for low-volume TAI minimum every other day\n\nExclusion Criteria:\n\n* Is participating in any other clinical investigation during this investigation\n* Has previously completed this investigation\n* Is former or current user of transanal irrigation (low- and high volume)\n* Has known hypersensitivity towards the device used in the investigation\n* Is pregnant\n* Has known anal stenosis\n* Has active\u002Frecurrent colorectal cancer\n* Has had anastomotic colorectal surgery within the last 3 months\n* Has ischaemic colitis\n* Has active inflammatory bowel disease\n* Has acute diverticulitis or diverticular abscess\n* Has medicine induced constipation (e.g. due to opioids)\n* Has chronic diarrhea\n* Has bowel dysfunction due to neurogenic disorder(s)\n* Is in need of high-volume TAI (as estimated by investigator)",{"count":51,"type":20},60,"INTERVENTIONAL",[54],"NA","The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and\u002For time-consuming bowel management procedures.\n\nThe primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.",[26,57],"Constipation - Functional",[59],"trans anal irrigation","2026-04-13",{"date":62,"type":34},"2026-04-14",{"date":64,"type":34},"2025-11-10",{"date":66,"type":20},"2026-08-01",{"name":68,"class":69},"Coloplast A\u002FS","INDUSTRY",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100629357","outcome-research-in-bowel-irrigation-techniques-for-the-treatment-of-chronic-constipation-andor-faecal-incontinence-100629357","NCT07473622","Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and\u002For Faecal Incontinence","Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and\u002For Faecal Incontinence, a Real-world Randomised Explorative Investigation.","ORBIT-1","Inclusion Criteria:\n\n* Faecal incontinence (FI), chronic constipation (CC) or co-existing FI\u002FCC, all of heterogenous origin\n* Positive Rome IV criteria for functional constipation and\u002For positive Rome IV criteria for faecal incontinence\n* 18 years or older\n* Ability to understand written and spoken English (due to questionnaire validity)\n* Ability to understand and provide written, informed consent prior to any investigation-specific procedures\n\nExclusion Criteria:\n\n* Prior use of transanal irrigation\n* Neurogenic bowel dysfunction\n* Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).\n* Previous rectal and\u002For anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal\u002Frectal abscess, or other rectal or anal surgeries deemed minor by the investigator)\n* Physical disability that affects the ability to independently use the irrigation device\n* Intermittent use of opioids inducing chronic constipation\n* Patulous anus\n* Participation in research conflicting with the current investigation\n* Physical or mental conditions affecting the ability to comply with the clinical investigation plan\n* Pregnancy or plans to become pregnant during the investigation period",{"count":80,"type":20},66,[54],"This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA\u002FCE-marked transanal irrigation products for the management of faecal incontinence and\u002For chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits\u002Fphone calls as the only difference from typical clinical procedure.\n\nDuring 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.",[26,84],"Chronic Constipation","NOT_YET_RECRUITING","2026-03-10",{"date":88,"type":34},"2026-03-16",{"date":66,"type":20},{"date":91,"type":20},"2028-02",{"name":93,"class":69},"Qufora A\u002FS",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":104,"studyType":21,"phases":4,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100432993","functional-digestive-disorders-observatory-100432993","NCT04918329","Functional Digestive Disorders Observatory","Observatory of Functionnal Digestive Disorders","OTFI","Inclusion Criteria:\n\n* Patients over 18 years of age;\n* Patients with functional digestive disorder for more of 3 months;\n* Patients assessed as part of routine care;\n* Patients affiliated to the Social Security ;\n* Patients not opposed to participation in the Centre\n\nExclusion Criteria:\n\n* Person deprived of liberty by administrative or judicial decision or major protected subject (under guardianship or curatorship);\n* Patients unable for any reason to read, understand, respond questionnaires (visual, psychiatric, cognitive, etc.)",{"count":103,"type":20},2000,"10 Years","Functional digestive pathologies are defined by symptoms such as functional dyspepsia, gastroesophageal reflux, irritable bowel syndrome, gastroesophageal reflux, functional constipation, functional diarrhea, functional bloating, the opioid-induced constipation and fecal incontinence, without organic substratum. These diseases are very common in the general population (20%) and represent the first cause of consultation in city gastroenterology. The pathophysiology of these functional disorders is complex and often multifactorial: disturbances in digestive motility, altered visceral sensitivity, sphincter dysfunction, post-surgery, intestinal inflammation, dysbiosis, and impairment of the gut-brain axis. For example, it has been shown that one in four patients with inflammatory bowel disease in confirmed remission report digestive symptoms consistent with a functional bowel disorder, suggesting a possible pathophysiological continuum between these two conditions.\n\nThe objective of this study is to collect prospective clinical and tests data and a biological collection from biological samples (digestive biopsies, blood, urine and fecal samples) collected as part of the standard care. This collection could identify diagnostic or prognostic markers of the therapeutic response.",[107,108,109,26,110,111],"Irritable Bowel Syndrome","Dyspepsia","Functional Constipation","Abdominal Pain (AP)","Vomiting Syndrome",[113,114],"Observatory","functional digestive disorders","2026-01-05",{"date":117,"type":34},"2026-01-08",{"date":119,"type":34},"2020-10-09",{"date":121,"type":20},"2030-10-09",{"name":123,"class":41},"University Hospital, Rouen",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":124},"100481566","prospective-database-of-factors-associated-with-faecal-vs-double-incontinence-in-patients-referred-for-high-resolution-anorectal-manometry-100481566","NCT05550675","Prospective Database of Factors Associated With Faecal vs. Double Incontinence in Patients Referred for High Resolution Anorectal Manometry.","Inclusion Criteria:\n\n* Age \\> 18 years;\n* Self-reported faecal incontinence.\n\nExclusion Criteria:\n\n* Impossibility to perform the anorectal manometry because of pain, stenosis or organic disease;\n* Active (peri)rectal inflammation, including abscess;\n* Pregnancy;\n* Inability to cooperate during the anorectal manometry\n* Impossibility to perform HARM due to pain, stenosis or organic disease;\n* Inability to complete the questionnaires",true,{"count":133,"type":20},150,"This study aims to verify the results from our previous retrospective cohort analysis by establishing a database of well-characterised patients prospectively. The different prevalence of neurological disorders, abdominal, urological and obstetrical surgery, diarrhoea and other potential associated factors as well as the importance of abnormalities identified by 3D high resolution anorectal manometry (HARM) will be compared between subjects with feacal incontinence (FI), double incontinence (DI) and controls. Presence and severity of both FI and urinary incontinence (UI) will be evaluated by disease specific questionnaires. Measuring both disease severity and Quality of Life (QoL) is needed to determine the true impact of incontinence. Finally, the impact on quality of life will be compared between both groups.",[136,26,137],"Double Incontinence","Urinary Incontinence","2025-12-11",{"date":140,"type":34},"2025-12-18",{"date":142,"type":34},"2022-06-08",{"date":144,"type":20},"2030-07",{"name":146,"class":41},"Universitair Ziekenhuis Brussel",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":154,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":52,"phases":157,"briefSummary":158,"conditions":159,"keywords":160,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":124},"100609270","sacral-neuromodulation-in-patients-with-double-incontinence-100609270","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",{"count":156,"type":20},30,[54],"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.",[136,26,137],[161,162,163,164],"Double incontinence","Faecal incontinence","Urinary incontinence","Sacral neurostimulation","2025-09-30",{"date":167,"type":34},"2025-10-08",{"date":169,"type":20},"2025-11",{"date":171,"type":20},"2029-12",{"name":173,"class":41},"University Hospital Ostrava",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":131,"sex":154,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":124},"100527077","care-for-oasi-study-care-pathways-and-anorectal-evaluation-for-oasi-associated-incontinence-100527077","NCT06143072","CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence","Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery","CArE for OAsI","Part 1 of Study\n\nInclusion Criteria:\n\n* • Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence following a vaginal delivery in the preceding five years (N.B. the average age of menopause in the UK is 51)\n\n  * Tertiary referrals to the specialist perineal clinic as well as patients who have 'slipped' through the existing pathway of referral\n  * Capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher)\n  * English-speaking and able to comprehend and read English\n  * Primiparous\u002Fmulti-parous\n\nExclusion Criteria:\n\n* • Women who are unable to consent or who have severe mental illness, as decided by the screening clinician\n\n  * Patients who do not speak, read or understand English\n  * Patients with an alternative documented cause for their FI that is non obstetric trauma related.\n  * Post-menopausal women who may develop late onset symptoms of incontinence relating to a previous OASI (clinically silent injuries that manifest in later life secondary to hormonal influences or advancing age for example).\n  * Women with an OASI who have been referred directly from the maternity unit at the same trust as the specialist perineal clinic, where an existing trust policy exists for direct referral of these patients from the maternity unit to the perineal clinic.\n\nPart 2 of study:\n\nInclusion criteria:\n\n• urogynaecologists\u002Fobstetricians who oversee the care of or look after patients with OASI and who are practising in UK NHS hospitals at the time of completion of the survey. They must be on the GMC specialist register to be eligible to participate\n\nExclusion criteria:\n\n• trainees, obstetricians\u002Fgynaecologists not routinely involved in the care of OASI patients.","50 Years",{"count":184,"type":20},112,"The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision.\n\nAs obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.",[187,188,189,190,191,26,192,193,194,195,196,197,198,199],"Obstetric Anal Sphincter Injury","Severe Perineal Trauma","Grade 3 Perineal Tear","Grade 4 Perineal Tear","Anal Incontinence","Urgency","Deferral Time","Pathways","Follow-up","Review","Endo-anal Ultrasound","Urogynaecology","Biofeedback","2025-05-21",{"date":202,"type":34},"2025-05-25",{"date":204,"type":34},"2024-01-01",{"date":206,"type":20},"2025-07-01",{"name":208,"class":41},"London North West Healthcare NHS Trust"]