[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fecal-incontinence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fecal-incontinence":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,45,73,96,118,156,178,199,224,248,273,306,329,349,378,401,427,463,487,509,532,562,589,610,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100533071","testing-the-safety-and-efficacy-of-a-novel-barrier-cream-for-the-treatment-of-moisture-associated-skin-damage-100533071",false,"NCT06221046","Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage","Prospective Evaluation of the Safety and Efficacy of an Enhanced Barrier Cream for the Treatment of Moisture Associated Skin Damage","Patients who meet all the below criteria will be eligible for inclusion in the study:\n\n* ≥18 years of age;\n* Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and\u002For fecal incontinence;\n* Minimum expected stay in hospital of two weeks;\n* Able to provide written informed consent (OR consent by a recognized substitute-decision maker) including explicit consent to take daily photographs of the rash associated with MASD.\n\nPatients who meet any of the following exclusion criteria will not be eligible for enrolment:\n\n* History of complex skin disorders (such as psoriasis or eczema);\n* Allergy to any of the ingredients in the study product;\n* Visual evidence of a bacterial skin infection;\n* Anticipated length of stay in hospital less than two weeks;\n* Life expectancy less than two weeks;\n* Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care.\n\nNote: Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD), and clinical evidence suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. There are no known products on the market that treat fecal incontinence or MASD caused by fecal enzyme activity.\n\nScotiaderm has invented a novel barrier cream (Dermategrity \"Anti-fecal\" Barrier Cream) with an enhanced formula containing zinc oxide and a natural plant extract that inhibits fecal enzymes to protect the skin while preventing further breakdown. Dermategrity \"Anti-fecal\" Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have been obtained in clinical case studies. To date, however, there has been no formal clinical testing of this new barrier product in comparison to standard zinc oxide creams.\n\nThe purpose of this study is to perform a randomized, controlled clinical study comparing Dermategrity \"Anti-fecal\" Barrier Cream to zinc oxide barrier cream to determine if there is a difference in healing, clinical outcomes, and the speed of resolution of MASD symptoms between groups.",[27,28,29],"Moisture Associated Skin Damage","Incontinence Associated Dermatitis","Fecal Incontinence",[31,27,28,32,29],"MASD","IAD","NOT_YET_RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":21},"2026-08-31",{"date":41,"type":21},"2027-08-01",{"name":43,"class":44},"Scotiaderm","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100633265","improving-the-care-of-incontinence-associated-dermatitis-iad-using-a-beta-glucan-cream-as-a-hydrating-and-soothing-agent-100633265","NCT07524439","Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent","Eligible participants are adults (≥18 years) with IAD secondary to urinary and\u002For fecal incontinence and an expected hospital stay of ≥7 days. Written informed consent will be obtained directly or via substitute decision-maker. Exclusion criteria include absence of IAD or incontinence, pediatric patients, and participants with known hypersensitivities to components of cream (e.g. beta-glucan).",{"count":20,"type":21},[24],"The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, accelerate visible recovery, reduce discomfort, and improve both patient and clinician experiences. The study will also learn about the safety and tolerability of the β-glucan cream when used along with standard skin care.\n\nThe main questions it aims to answer are:\n\nAre there visible changes in the severity of IAD when β-glucan cream is added to standard care, and if so, to what extent does it reduce severity compared with standard care alone?\n\nDoes the β-glucan cream help IAD heal faster?\n\nDoes the cream reduce symptoms such as pain, itching, tingling, or burning?\n\nWhat medical problems or side effects, if any, do participants experience while using the β-glucan cream?\n\nResearchers will compare standard care plus β-glucan cream to standard care alone to see if the β-glucan cream provides additional benefit for treating IAD.\n\nParticipants will:\n\nReceive either β-glucan cream plus standard care or standard care alone\n\nHave the study cream applied once daily for up to 2 weeks\n\nHave their skin checked weekly by the study team using a standardized assessment tool\n\nAnswer questions about symptoms such as pain, itching, tingling, and burning\n\nAllow photographs of the affected skin area to be taken for secure clinical review\n\nBe monitored for any side effects or skin reactions during the study",[29,55,56,57,58],"Urinary Incontinence","Diaper Rash","Irritant Contact Dermatitis Caused by Faeces","Irritant Contact Dermatitis",[60,61],"Administration, Topical","Administration, Cutaneous","RECRUITING","2026-06-23",{"date":65,"type":37},"2026-06-26",{"date":67,"type":37},"2026-05-01",{"date":69,"type":21},"2028-11-30",{"name":71,"class":44},"University of Alberta",1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":72},"100544573","testing-a-novel-barrier-cream-for-fecal-incontinence-in-an-ambulatory-population-100544573","NCT06370637","Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population","Comparison of an Enhanced Barrier Cream to Standard of Care for the Treatment of Moisture Associated Skin Damage From Fecal Incontinence in an Ambulatory Population","Inclusion Criteria\n\n* ≥18 years of age\n* Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and\u002For fecal incontinence.\n* Able to provide written informed consent\n* Either able to self-administer barrier cream to the affected region OR administer with the assistance of a caregiver\n\nExclusion Criteria\n\n* History of complex skin disorders (such as psoriasis or eczema)\n* Known allergy to any of the ingredients in the study product\n* Visual evidence of a bacterial skin infection\n* Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care.\n* Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments\n* A medical condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent OR presents confounds which may bias the study outcomes",{"count":81,"type":21},40,[24],"Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD), and clinical evidence suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. There are no known products on the market that treat fecal incontinence or MASD caused by fecal enzyme activity.\n\nScotiaderm has invented a novel barrier cream (Dermategrity Everyday Barrier Cream) with an enhanced formula containing zinc oxide and a natural plant extract that inhibits fecal enzymes to protect the skin while preventing further breakdown. Dermategrity Everyday Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have been obtained in clinical case studies. To date, however, there has been no formal clinical testing of this new barrier product in comparison to standard zinc oxide creams.\n\nThe purpose of this study is to perform a randomized, controlled clinical study comparing Dermategrity Everyday Barrier Cream to zinc oxide barrier cream to determine if there is a difference in healing, clinical outcomes, and the speed of resolution of MASD symptoms between groups, in an ambulatory patient population.",[27,29,28],[31,27,32,28,29,86,87],"Dermategrity","Barrier Cream","2026-06-22",{"date":90,"type":37},"2026-06-25",{"date":92,"type":21},"2026-09-01",{"date":94,"type":21},"2027-11-01",{"name":43,"class":44},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":18,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":72},"100576480","early-phase-1-intra-rectal-botulinum-toxin-injection-for-intractable-non-retentive-fecal-incontinence-in-children---an-open-label-pilot-study-100576480","NCT06785844","Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study","Inclusion Criteria:\n\n* Children 4-18 years old with fecal incontinence for a period greater than 6 months.\n* FI frequency of ≥ 3 episodes\u002Fweek.\n* After appropriate medical evaluation, FI cannot be explained by another medical condition.\n* Normal colonic transit study, defined as passage of 80% of markers on day\n* Normal RAIR on anorectal manometry\n\nExclusion Criteria:\n\n* Patients currently fulfilling rome IV criteria for functional constipation.\n* Patients with evidence of fecal retention.\n* Patients who had had good response to treatment for overflow incontinence.\n* Absent RAIR on anorectal manometry.\n* Any radiologic evidence of dochylosigmoid or distended colon.\n* Any known organic condition that may affect bowel transit.","4 Years",{"count":104,"type":21},14,[106],"EARLY_PHASE1","Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.\n\nObjectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.\n\nMethods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.\n\nSignificance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.",[29],"2026-06-17",{"date":111,"type":37},"2026-06-18",{"date":113,"type":37},"2025-07-01",{"date":115,"type":21},"2030-09",{"name":117,"class":44},"Shaare Zedek Medical Center",{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":125,"targetDuration":127,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":139,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":72},"100401388","indiana-university-gastrointestinal-motility-diagnosis-registry-100401388","NCT04506593","Indiana University Gastrointestinal Motility Diagnosis Registry","Gastrointestinal Motility Diagnosis Registry","Inclusion Criteria:\n\n1. Patients who presented to the GI outpatient clinics, in-patient consult service, and outpatient endoscopy centers within the Division of Gastroenterology and Hepatology\n2. Carries a diagnosis of GI motility disorder based on the diagnostic criteria listed in table\n\nExclusion Criteria:\n\n1\\. Coexisting medical conditions that may limiting participation in clinical research trial",{"count":126,"type":21},5000,"10 Years","OBSERVATIONAL","Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders",[131,132,133,134,135,136,137,29,138],"Eosinophilic Esophagitis","Gastroesophageal Reflux Disease (GERD)","Gastroparesis","Functional Vomiting","Irritable Bowel Syndrome (IBS)","Constipation","Chronic Intestinal Pseudo-obstruction","Small Intestinal Bacterial Overgrowth",[140,141,142,143,144,145,146,133],"Eosinophilic esophagitis","Chronic intestinal pseudo-obstruction","Small Bowel dysmotility","SIBO","Vomiting","Functional dyspepsia","Functional bloating","2026-06-15",{"date":149,"type":37},"2026-06-16",{"date":151,"type":37},"2014-11-01",{"date":153,"type":21},"2026-11",{"name":155,"class":44},"Indiana University",{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":72},"100631329","axonics-r20-post-market-clinical-follow-up-pmcf-study-for-the-indication-of-fecal-incontinence-100631329","NCT07499258","Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence","Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)","Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of Fecal Incontinence (FI)\n3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers\n\nExclusion Criteria:\n\n1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)\n2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements\n3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n4. A female who is breastfeeding\n5. A female with a positive urine pregnancy test",{"count":164,"type":21},55,"Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.",[29],[29,168],"Sacral Neuromodulation","2026-06-11",{"date":147,"type":37},{"date":172,"type":21},"2026-06",{"date":174,"type":21},"2029-12",{"name":176,"class":177},"Axonics, Inc.","INDUSTRY",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":72},"100537070","treatment-of-fecal-incontinence-and-functional-evacuation-disorders-using-non-instrumental-biofeedback-100537070","NCT06273046","Treatment of Fecal Incontinence and Functional Evacuation Disorders Using Non-instrumental Biofeedback","Tratamiento de la Incontinencia Fecal y Los Trastornos Funcionales de la defecación Mediante Biofeedback no Instrumental","Inclusion Criteria:\n\nIncontinence studies\n\n* Patients who have at least 4 episodes of fecal incontinence during the last 14 days.\n* Patients able to follow instructions and attend study visits.\n\nDyssinergic defecation studies\n\n* Patients with constipation who present less than 3 complete spontaneous bowel movements per week and\u002For who have Bristol 1 or Bristol 2 type stools in more than 25% of the bowel movements in the 2 weeks prior to the study\n* Patients able to follow instructions and attend study visits.\n\nExclusion Criteria:\n\n* Patients with organic digestive diseases such as inflammatory bowel disease, celiac disease, gastro-duodenal ulcer...\n* Patients with neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease).\n* Patients with previous of active colon and\u002For rectal cancer.\n* Patients with rectal fistula.\n* Patients with rectal prolapse.\n* Patients with total colectomy.\n* Patients who have had any radiation to the pelvis in the last month.","75 Years",{"count":187,"type":21},96,[24],"Background. Rehabilitation and re-education using instrumental anorectal biofeedback are the main treatment of anorectal functional disorders producing incontinence and outlet obstructed defecation. These treatments imply intubation of patient and several sessions of treatment leading to high consumption of resources and costs.\n\nHypothesis. A cognitive intervention based on original audiovisual programs developed specifically for the management of anorectal functional disorders is effective in correcting anorectal function disorders that cause fecal incontinence and evacuation disorders.\n\nAim. To prove in two different protocols (fecal incontinence and dyssinergic defecation) the efficacy of specifically developed non-instrumental biofeedback techniques.\n\nSelection criteria. Patients with fecal incontinence and altered sphincter function and patients with outlet obstructed evacuation referred for biofeedback treatment.\n\nIntervention. In separate studies (incontinence and dyssynergic defecation) patients will be randomized into biofeedback and placebo groups. One session of either biofeedback or placebo intervention will be performed at the beginning of the intervention period and patients will be instructed to performed the assigned daily treatment at home. A visit for outcome assessment will be performed at 3 months in incontinence study and at 4 weeks in the dyssinergic defecation study. In addition, in the incontinence study a phone call will be performed after 6 months of the beginning of the study to evaluate treatment outcome.\n\nBiofeedback: patients will be taught to control anal and abdominal muscular activity by providing instructions using original video supports. Patients will be instructed to perform the same exercises daily at home in scheduled times.\n\nPlacebo: a pill of placebo containing 0.3 g glucose will be administered every day at home.",[29,191],"Outlet Dysfunction Constipation",{"date":147,"type":37},{"date":194,"type":37},"2024-04-17",{"date":196,"type":21},"2026-08-30",{"name":198,"class":44},"Hospital Universitari Vall d'Hebron Research Institute",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":72},"100637891","active-versus-passive-anal-sphincter-training-in-patients-with-fecal-incontinence-100637891","NCT07604415","Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence","ACTIPAST","Inclusion Criteria:\n\n* Signed informed consent\n* Age ≥18 years\n* Diagnosis of fecal incontinence (urge, passive, or mixed type) with at least 1 episode of involuntary stool leakage requiring hygiene intervention or underwear change per month for ≥3 months\n* Vaizey (St. Mark's) Incontinence Score ≥8\n* Ability to understand study procedures and comply with the 12-week home intervention\n* Willingness to attend all study visits and assessments\n* Stable medical management for fecal incontinence for at least 4 weeks prior to enrollment\n\nExclusion Criteria:\n\n* Complete spinal cord injury above the conus medullaris\n* Active inflammatory bowel disease flare requiring systemic therapy or not in clinical remission\n* Rectal prolapse requiring surgical intervention\n* Severe symptomatic hemorrhoids interfering with anorectal assessments or device use\n* Active anal fissure or perianal fistula\n* Active colorectal cancer or history of colorectal cancer within 5 years\n* Colorectal surgery within the previous 6 months\n* Pregnancy or planned pregnancy during study participation\n* Implanted cardiac pacemaker or defibrillator\n* Other implanted electrical devices contraindicating electrical stimulation\n* Previous specialized pelvic floor physiotherapy, biofeedback therapy, EMG-guided rehabilitation, or anal electrical stimulation within 3 months prior to randomization\n* Cognitive impairment preventing understanding of study procedures or informed consent\n* Uncontrolled severe diarrhea (\\>5 liquid stools\u002Fday)\n* Anal stenosis preventing probe insertion\n* Severe anal sphincter defect (\\>120° on ultrasound) requiring surgical repair\n* Isolated severe rectal sensory dysfunction without significant sphincter dysfunction\n* Previous pelvic radiotherapy\n* Concurrent participation in another interventional clinical trial",{"count":207,"type":21},24,[24],"Fecal incontinence is a disabling condition that can substantially impair quality of life. This study evaluates whether home-based anal electrical stimulation combined with active voluntary anal sphincter contraction is superior to electrical stimulation alone in patients with fecal incontinence.\n\nThe study is a prospective, randomized, parallel-group, open-label controlled trial. Participants will be randomized in a 1:1 ratio to either electrical stimulation with synchronized active sphincter contraction or electrical stimulation alone. The primary outcome is the change in Vaizey\u002FSt. Mark's Incontinence Score from baseline to week 12. Secondary outcomes include fecal incontinence episodes, quality of life, anorectal manometry parameters, adherence, safety, and sustained response during follow-up.",[29],[212,213,214],"fecal incontinence","anal stimulation","pelvic floor training","2026-05-22",{"date":217,"type":37},"2026-05-28",{"date":219,"type":37},"2026-05-15",{"date":221,"type":21},"2029-05",{"name":223,"class":44},"University Hospital, Martin",{"id":225,"slug":226,"hasResults":12,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100454698","pelvic-health-electrically-evoked-recording-peer-2-study-100454698","NCT05200923","Pelvic Health Electrically Evoked Recording (PEER) 2 Study","PEER 2","Inclusion Criteria:\n\nOveractive Bladder Criteria Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any OAB medication from baseline diary through the end of therapy evaluation\n6. For subjects with urinary urge incontinence, have a diagnosis of OAB as demonstrated on a voiding diary by having a minimum of 3 episodes of urinary urge incontinence in the first 72 hours (Episodes must have a mild, moderate, or severe degree of urgency to meet this criterion) of the voiding diary.\n7. For subjects with urinary frequency, have a diagnosis of OAB as demonstrated on a voiding diary with greater than or equal to 8 urgency frequency episodes per day within the first 72 hours of the voiding diary.\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nNon-Obstructive Urinary Retention Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant for labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any NOUR medication from baseline diary through the end of therapy evaluation\n6. Have a diagnosis of non-obstructive urinary retention with an elevated postvoid residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nFecal Incontinence Inclusion Criteria\n\n1. 18 years of age or older\n2. Candidate for or undergoing Medtronic InterStim lead implant labeled indication\\* requiring an advanced evaluation\n3. Willing and able to provide signed and dated informed consent\n4. Willing and able to independently and accurately complete diaries, questionnaires, attend visits, and comply with the study protocol\n5. Willing to maintain current regimen (dosage and frequency) of any FI medication from baseline diary through the end of therapy evaluation\n6. Have a diagnosis of fecal incontinence as demonstrated by 3-day a bowel diary as greater than or equal to 1 incontinent episode of more than staining (i.e., either slight, moderate, or severe soiling)\n\nNote\\*: Candidate for or undergoing a Medtronic InterStim lead implant for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic Interstim lead implant to treat the subject's condition. This decision is to be made prior to discussing with the patient whether to enroll in the study.\n\nExclusion Criteria:\n\nOveractive Bladder Criteria Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. History of diabetes unless the diabetes is well-controlled through diet and\u002For medications\n6. Have symptomatic urinary tract infection (UTI)\n7. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component\n8. Treatment of voiding behavior with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study\n9. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n10. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n11. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n12. Women who are pregnant or planning to become pregnant\n13. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)\n14. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements\n\nNon-Obstructive Urinary Retention Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. History of diabetes unless the diabetes is well-controlled through diet and\u002For medications\n6. Have symptomatic urinary tract infection (UTI)\n7. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n8. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n9. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n10. Women who are pregnant or planning to become pregnant\n11. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)\n12. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements\n\nFecal Incontinence Exclusion Criteria\n\n1. Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)\n2. Implanted with a neurostimulator, pacemaker or defibrillator\n3. Pelvic floor muscle dysfunction due to surgical intervention or injury\n4. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)\n5. Have uncorrected high grade internal rectal prolapse\n6. Treatment of symptoms with tibial neuromodulation therapy in the last 3 months\n7. Have knowledge of planned magnetic resonance imaging (MRIs) during the therapy evaluation portion of the study\n8. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy\n9. Women who are pregnant or planning to become pregnant\n10. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements",{"count":232,"type":21},300,[24],"To collect physiological signals at several timepoints during the therapy evaluation period.",[236,29,237],"Overactive Bladder","Urinary Retention","2026-03-02",{"date":240,"type":37},"2026-03-03",{"date":242,"type":37},"2022-01-18",{"date":244,"type":21},"2026-12-18",{"name":246,"class":177},"MedtronicNeuro",7,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":22,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":271,"locationsCount":72},"100469718","autologous-muscle-fiber-fragment-injections-100469718","NCT05396456","Autologous Muscle Fiber Fragment Injections","Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence","Inclusion Criteria:\n\n* 18 years of age\n* participants must experience 4 or more Fecal Incontinence (FI) episodes per 2 week period\n* participants must score \\>10 on Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS)\n* participants must have had symptoms for at least 12 months\n* participants who have failed standard medical and surgical treatments for FI\n* participant will undergo anorectal manometry (ARM) testing\n* participants will undergo endoscopic anal ultrasound and demonstrate an anatomic defect of the anal sphincter complex of at least 30 degrees\n* women of childbearing potential must use acceptable contraceptives during this study\n\nExclusion Criteria:\n\n* participants with symptomatic anorectal disease including symptomatic hemorrhoid disease, anal fissure or fistula causing symptoms such as bleeding, swelling, pain, or drainage\n* participants with pre-existing ano-rectal pain of any cause\n* participants with incontinence of flatus only\n* chronic watery diarrhea which is the primary cause for fecal incontinence\n* acute or chronic anorectal infections (including proctitis, recurrent abscesses, fistulae)\n* presence of anorectal tumors\n* active proctitis or inflammatory bowel disease\n* previous injection of internal anal sphincter (IAS) with bulking agents\n* participants requiring immunosuppression or who have any malignant disease within 3 years of enrollment\n* participants with a defined bleeding disorder diagnosed and treated by a hematologist\n* other exclusions include history of pelvic radiation, rectal prolapse, anorectal malformations, anorectal surgery within the previous 12 months, or treatments using injection or infrared coagulation for treatment of hemorrhoids\n* participants with neurologic disease characterized by significant peripheral neuropathy or spinal cord dysfunction\n* women who are pregnant, breastfeeding, or have had a child within the last year\n* participants with a history of unstable cardiac function (New York Heart Association Functional Classification III or IV) or unstable pulmonary function requiring home oxygen, or abnormal kidney function (Cr \\>1.5 mg\u002Fdl or on dialysis) or uncontrolled diabetes (Hemoglobin A1C \\> 8 mg\u002Fdl)\n* participants with anemia (hemoglobin \\\u003C10g, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2 times normal) or increased bilirubin \\>1.5mg\u002Fdl\n* participants with Hepatitis B or C, or human immunodeficiency virus (HIV)-1 or 2\n* rectal prolapse\n* vaginal prolapse beyond the hymen\n* unable to understand informed consent information even with provision of a medical translator",{"count":256,"type":21},10,[24],"To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)",[29],[261,262,263,264],"low anal pressures","passive incontinence","bowel movements","sphincter muscle","2026-02-25",{"date":267,"type":37},"2026-02-27",{"date":269,"type":37},"2023-01-12",{"date":174,"type":21},{"name":272,"class":44},"Wake Forest University Health Sciences",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":280,"minAge":18,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":284,"conditions":285,"keywords":292,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},"100523126","safety-and-performance-of-ucon-bar-electrode-for-the-treatment-of-overactive-bladder-oab-and-bowel-dysfunction-bd-100523126","NCT06091566","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study","Inclusion Criteria:\n\n1. Participant is female\n2. Participant is ≥ 18 years of age.\n3. Participant is diagnosed with OAB or BD.\n\n   OAB: Urinary urgency usually with one or more of the following:\n\n   i. Urinary urgency incontinence (≥1 per\u002Fweek). ii. Urinary frequency (≥8 voiding\u002Fday without polyuria). iii. Nocturia (≥2 voiding\u002Fnight without nocturnal polyuria).\n\n   BD: One or more of the following:\n\n   i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.\n\n   ii. Faecal incontinence (urge\u002Fpassive) (≥1 per\u002Fweek).\n4. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.\n\nExclusion Criteria:\n\n1. Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participants´ participation in the investigation).\n2. Participant has an active infection in the genital area.\n3. Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).\n4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.\n5. Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.\n6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.\n7. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.\n8. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n9. Participant does not speak or understand Danish.\n\n   * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.","FEMALE",{"count":282,"type":21},20,[24],"UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder\u002Fbowel musculature e.g., suppress undesired bladder\u002Fbowel activity to relieve the symptoms of the patient.\n\nThis clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.",[55,286,29,287,288,289,290,291],"Urinary Incontinence, Urge","Fecal Incontinence With Fecal Urgency","Nocturia","Urinary Frequency More Than Once at Night","Bowel Disorders Functional","Incontinence, Nighttime Urinary",[55,29,293,294,295],"Urge incontinence","Neurostimulation","Dorsal Genital Nerve","2026-02-16",{"date":298,"type":37},"2026-02-18",{"date":300,"type":37},"2024-01-12",{"date":302,"type":21},"2027-01-01",{"name":304,"class":177},"InnoCon Medical",3,{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":72},"100515951","phase-3-mechanisms-of-action-on-rectal-motricity-of-intrarectal-botulinum-toxin-injections-100515951","NCT05998187","Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections","Mechanisms of Action on Rectal Motricity of Intrarectal Botulinum Toxin Injections in Patients With Fecal Incontinence","MECA-TOX","Inclusion Criteria:\n\n* Active or predominantly active fecal incontinence with failure of 1st-line conservative treatments (normalization of transit, perineal re-education)\n* Impairment of quality of life at investigator's discretion\n* Patients at least 18 years of age\n* Patients who have read and understood the information letter and signed the consent form\n* Patients affiliated to the French Social Security system\n* Women of childbearing age using effective contraception (Cf. CTFG) (estro- progestins or intrauterine device or tubal ligation) for at least 1 month and a negative B-HCG urine pregnancy test at inclusion and for the duration of the study.\n* Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhea for at least 12 months prior to inclusion visit)\n\nExclusion Criteria:\n\nGeneral\n\n* Pregnant women, women in labor, breastfeeding women, or women without proven contraception\n* Patient deprived of liberty by administrative or judicial decision, or protected adult (under guardianship or trusteeship)\n* Exclusive passive fecal incontinence\n* Patient suffering from constipation (Rome IV criteria)\n* Patient with an evolving inflammatory or cancerous digestive pathology\n* Previous rectal surgery\n* Person participating in another research protocol or having participated in another research protocol in the 4 weeks preceding the inclusion visit\n\nLinked to botulinum toxin injections\n\n* Hypersensitivity to botulinum toxin or to one of the excipients (human albumin, sodium chloride)\n* Neuromuscular junction pathology (myasthenia, Lambert-Eaton syndrome, etc.)\n* Presence of infection at injection site(s)\n* General anesthesia less than one month ago\n* Association with aminoglycosides and anti-cholinesterase agents (risk of increased toxin effects)\n* History of neurogenic damage such as polyradiculoneuritis\n* History of dysphagia with esophageal or neurological stasis, swallowing disorders, inhalation pneumonitis\n* Botulinum toxin injections in the 3 months preceding the study\n* Clinical anal examination suggestive of anorectal abscess\n* Recent history (\\\u003C12 months) of myocardial infarction and\u002For rhythm disorders not reduced by appropriate treatment\n* Peripheral motor neuropathies (such as amyotrophic lateral sclerosis or motor neuropathy) and underlying neurological disorders\n* Current treatment with anticoagulants or anti-aggregants or haemostasis disorders according to recommendations (SFED). When patients are on anticoagulant or anti-aggregant therapy, the type of injections to be performed depends on the type of anticoagulation and the patient's thrombo-embolic risk:\n* Patients on anticoagulant or anti-aggregant therapy with a major thrombo-embolic risk will not be included.\n* Patients on anticoagulant or anti-aggregant therapy with a moderate or low thrombo-embolic risk may be included. If patients are taking a vitamin K antagonist, treatment will be continued provided that the INR is within the usual range of 2 to 3 (GETED, HAS, 2008). If patients are taking anti-aggregants, these can be continued (SFED, HAS, 2012). If patients are taking new oral anticoagulants, they should take a short break and not take the AOD the evening before or the morning of the injections (GIHP, 2015).\n\nLinked to rectosigmoidoscopy\n\n* Local pathology preventing colonoscopy (anal stenosis)\n* Allergy or hypersensitivity to silicone and\u002For latex\n\nLinked to laxatives\n\n* Contraindication to DULCOLAX® 5 mg, gastro-resistant coated tablet\n* Contraindication to XIMEPEG®, powder for oral solution\n\nLinked to high-resolution manometry\n\n* Clinically diagnosed intestinal obstruction\n* Severe coagulopathy or oral anticoagulants\n* Cardiac disorders for which vagal stimulation is poorly tolerated",{"count":315,"type":21},21,[317],"PHASE3","Previous studies have demonstrated the efficacy of this treatment in certain patients suffering from fecal incontinence, but it is not yet reimbursed in this indication as it is still in the evaluation phase. Indeed, little is known about botulinum toxin mechanisms of action. The aim of this study is to better understand the mechanisms of action of intra-rectal botulinum toxin injections, so that the investigators can identify the patients most likely to benefit from this treatment in the future.",[29],"2026-01-20",{"date":322,"type":37},"2026-01-22",{"date":324,"type":37},"2025-04-15",{"date":326,"type":21},"2027-12-01",{"name":328,"class":44},"University Hospital, Rouen",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":72},"100617012","mechanisms-of-fecal-incontinence-in-wolfram-syndrome-100617012","NCT07313085","Mechanisms of Fecal Incontinence in Wolfram Syndrome","Physiopathogenic Mechanisms of Fecal Incontinence in Wolfram Syndrome","Inclusion Criteria:\n\n* Wolfram syndrome\n\nExclusion Criteria:\n\n* no information concerning fecal incontinence in data records",{"count":282,"type":21},"In order to clarify the mechanism of fecal incontinence in in Wolfram syndrome and to characterize its risk factors, the examiner will reviewed the files of patients followed in a Reference Center for Rare Diseases in Ophthalmology.",[339,29],"Wolfram Syndrome","2025-12-22",{"date":342,"type":37},"2025-12-31",{"date":344,"type":21},"2025-12-20",{"date":346,"type":21},"2026-02",{"name":348,"class":44},"Hôpital Necker-Enfants Malades",{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":72},"100487417","acute-genital-nerve-stimulation-for-neurogenic-bowel-dysfunction-in-individuals-living-with-spinal-cord-injury-100487417","NCT05626816","Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury","Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury","Inclusion Criteria:\n\n* Traumatic SCI\n* Minimum 6 months post-injury\n* Aged 18 years or older\n* Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI\n* Response to genital nerve stimulation upon screening\n* Able to understand and provide informed consent\n\nExclusion Criteria:\n\n* Currently enrolled in another functional electrical stimulation (FES) research trial\n* Females who are pregnant or planning to become pregnant during the trial\n* Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.\n* In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.",{"count":357,"type":21},52,[24],"Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.",[29],[362,363,364,365,366,367,368,369],"bowel","spinal cord injury","electrical stimulation","anorectal manometry","incontinence","tetraplegia","paraplegia","paralysis","2025-11-24",{"date":372,"type":37},"2025-12-02",{"date":374,"type":37},"2023-03-21",{"date":342,"type":21},{"name":377,"class":44},"MetroHealth Medical Center",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":385,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":72},"100556977","mechanisms-of-improving-fecal-continence-muscles-motor-function-100556977","NCT06532123","Mechanisms of Improving Fecal Continence Muscles Motor Function","Mechanisms of Improving Fecal Continence Muscles Motor Function in Health and Disease","Inclusion Criteria:\n\n* Healthy volunteers without past or present history of fecal incontinence\n* Patients age 18 years and older with reduced anal resting and or squeeze pressure, reflecting weakness of the anal sphincters who can perform the study\n\nExclusion Criteria:\n\n* Any one less than 18 years old\n* Neurological disorders like dementia, cerebrovascular diseases\n* Muscle diseases like muscular dystrophy, myopathies\n* Inflammatory bowel disease or celiac disease\n* Neuro-muscular junction disorders\u002Fmyasthenia gravis, Eaton-Lambert syndrome\n* Organ prolapse, large rectocele(\\>2cm), rectal intussusception\n* Hip dysplasia or recent hip surgery and immobile patients.\n* Patients with complete normal anal resting and squeeze pressure\n* Impaired rectal evacuation (dyssynergy defecation)\n* Fecal incontinence completely due to loss of rectal sensation\n* Subjects unable to contract their external anal sphincter at all",true,{"count":387,"type":21},340,[24],"The investigators hypothesize that different continence muscles have different fatigue characteristics and fatigue induced by resisted contractions will result in significant increase in contractility of the continence muscles and improvement of fecal incontinence severity.",[29],[212],"2025-10-21",{"date":394,"type":37},"2025-10-23",{"date":396,"type":37},"2025-07-15",{"date":398,"type":21},"2030-03-01",{"name":400,"class":44},"Medical College of Wisconsin",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":385,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":408,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100470915","trial-to-evaluate-fecobionics-in-fecal-incontinence-fi-normal-and-abnormal-fi-100470915","NCT05412069","Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)","A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)","Inclusion Criteria:\n\n1. Subject must provide written informed consent;\n2. Willing and able to undergo required study tests, surveys, and procedures;\n3. Age \\> 18 years of age.\n\nExclusion Criteria:\n\n1. Female who is pregnant;\n2. Prior anorectal surgery;\n3. Prior bowel resection;\n4. History of chronic constipation;\n5. In the opinion of the investigator, the subject is not a suitable candidate for the study.",{"count":409,"type":21},155,[24],"The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal.\n\nThe overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation (BET and FECOM) and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction.",[413,29],"Normal Subjects",[415,416,417],"anorectal","Fecobionics","defecation","2025-10-20",{"date":392,"type":37},{"date":421,"type":37},"2023-02-15",{"date":423,"type":21},"2027-03-31",{"name":425,"class":44},"The California Medical Innovations Institute, Inc.",2,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":385,"sex":280,"minAge":18,"maxAge":433,"enrollmentInfo":434,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":436,"conditions":437,"keywords":445,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":72},"100606457","pelvic-floor-disorder-symptoms-in-women-seeking-weight-loss-therapy-100606457","NCT07175805","Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy","Inclusion Criteria:\n\n* female\n* 18-89 years old\n* any race\u002Fethnicity\n* BMI ≥30 kg\u002Fm2\n* current medical weight loss or surgical weight loss patient of Obesity Medicine and Metabolic \\& Bariatric Surgery\n* able\u002Fwilling to give informed consent\n* have a home scale to measure weight\n\nPatients meeting all the following criteria will be eligible to participate in the medical weight loss therapy arm:\n\n* prescribed and start a glucagon-like peptide-1 receptor agonist (GLP-1 RA) or a GLP-1\u002Fgastric inhibitory peptide (GIP1)\n* taking other weight loss agents (such as metformin)\n\nPatients meeting all the following criteria will be eligible to participate in the bariatric surgery arm:\n\n* plan to undergo gastric sleeve or gastric bypass surgery\n* taking weight loss agents which are not GLP-1 RA or GLP-1\u002FGIP1 medications at the start of the study. Patients will not be excluded if they are started on GLP-1 RA or GLP-1\u002FGIP1 medications after surgery.\n\nExclusion Criteria:\n\n* Pregnant\n* ≥90 years old\n* \\\u003C18 years old\n* BMI \\\u003C30 kg\u002Fm2\n* A history of bariatric surgery prior to enrollment\n* No home scale to measure weight\n* Active cancer","90 Years",{"count":435,"type":21},200,"The purpose of this study is to compare change in pelvic floor symptoms between patients receiving medical therapy for weight loss and surgical treatment for weight loss. Examples of pelvic floor symptoms include urinary incontinence, urinary urgency, urinary frequency, fecal incontinence, and vaginal prolapse. Participants in this study do not need to have any pelvic floor symptoms to enroll in the study. Understanding how different types of weight loss treatment impact pelvic floor symptoms will help clinicians guide which weight loss treatments are recommended for patients with pelvic floor symptoms in the future.",[438,439,440,236,441,442,29,443,444],"Lower Urinary Tract Symptoms","Stress Urinary Incontinence","Urge Urinary Incontinence","Pelvic Organ Prolapse","Weight Loss","Bariatric Surgery","glp1 Agonist",[446,447,448,449,450,451,212,452,453],"lower urinary tract symtpoms","stress urinary incontinence","urge urinary incontinence","overactive bladder","pelvic organ prolapse","weight loss","bariatric surgery","glp1 agonist","2025-09-15",{"date":456,"type":37},"2025-09-16",{"date":458,"type":21},"2025-10",{"date":460,"type":21},"2027-06",{"name":462,"class":44},"Hartford HealthCare",{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":474,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":483,"leadSponsor":485,"locationsCount":72},"100595591","functional-outcomes-in-ulcerative-colitis-patients-with-ileal-pouch-anal-anastomosis-treated-with-high-intensity-focused-electromagnetic-stimulation-100595591","NCT07034443","Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation","Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU\n* Must be at least 1 year out from J pouch surgery\n* Have fecal incontinence\n\nExclusion Criteria:\n\n* Any records flagged \"break the glass\" or \"research opt out.\"\n* Pediatric Patients \\\u003C18 years of age\n* Did not receive a J pouch\n* Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis\n* Have active pouchitis\n* Have an active fistula\n* If reclassified to de novo Crohn's after surgery\n* Have implanted metal devices or medical devices\n* Pregnant patients",{"count":282,"type":21},[24],"The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.",[29],[475,29,476,477,478],"Ulcerative colitis","Functional Outcomes","High Intensity Focused Electromagnetic Stimulation","J pouch","2025-06-19",{"date":481,"type":37},"2025-06-24",{"date":113,"type":21},{"date":484,"type":21},"2026-06-01",{"name":486,"class":44},"Cedars-Sinai Medical Center",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":4,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":305},"100574046","safety-and-performance-of-ucon-patch-electrode-100574046","NCT06754189","Safety and Performance of UCon Patch Electrode","Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age.\n* Participant is diagnosed with OAB or BD.\n* Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.\n\nExclusion Criteria:\n\n* Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.\n* Participant has an active infection in the genital area, including skin infections.\n* Participant has injured or irritated skin in the genital area, where the electrode is placed.\n* Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).\n* Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).\n* Participant is pregnant, nursing, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception\\* during the clinical investigation.\n* Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.\n* Participant has previously participated in a clinical investigation with UCon.\n* Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.\n* Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.\n* Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region.\n* Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation.\n* Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n\n  * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.\n\nExclusion Criteria specific for OAB:\n\n* Participant is planning or has a scheduled surgery\u002Fdiagnostic procedure (within the duration of their participation) for any condition, that would require catheterization. Or have a prolonged hospitalization that would affect the ability to complete the stimulation.\n* Participant (male) has symptoms of bladder outlet obstruction, e.g., caused by benign prostatic hyperplasia or prostate cancer.\n* Participant has polyuria or symptoms of polyuria.\n* Participant has a current or reoccurring urinary tract infection (≥3 or more within the previous 12 months or ≥2 within the previous 6 months).\n* Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixed incontinence with SUI likely to confound outcome measures.\n* Participant has Bladder Pain Syndrome or interstitial cystitis.\n* Participant has had botulinum toxin (BOTOX) treatment in the pelvic region within 9 months or has lasting benefit from BOTOX.\n* Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2 years.\n* Participants who demonstrate detrusor overactivity on a urodynamic test can be included.\n* Participant has used antimuscarinics or β3 agonists within 2 weeks.\n* Participant has started oestrogen therapy within 3 months or are planning to stop therapy when enrolled in the clinical investigation.\n\nExclusion Criteria specific for BD:\n\n* Participant is planning or has a scheduled surgery\u002Fdiagnostic procedure (within the duration of their participation), for any condition, that would influence their bowel movements (e.g., injection of bulking agents, radiofrequency energy, or ligation of haemorrhoids). Or have a prolonged hospitalization that would affect the ability to complete the stimulation.\n* Participant is currently being treated with antibiotics.\n* Participant has a history of uncontrolled diarrhoea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale).\n* Participant has a history of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale).\n* Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis). Participants with irritable bowel syndrome can be included in the clinical investigation.\n* Participant has undergone major anorectal or bowel surgery or has ongoing anorectal or bowel conditions where primary surgery is considered the best, e.g., congenital anorectal malformation, bowel resection surgery, unrepaired rectovaginal fistula, chronic 4th degree anal sphincter laceration, full thickness rectal\u002Fanal prolapse. If it can be excluded that the participant's symptoms are related to any of the above surgeries\u002Fconditions, they can be included in the clinical investigation.",{"count":495,"type":21},180,[24],"UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder\u002Fbowel musculature e.g., suppressing undesired bladder\u002Fbowel activity to relieve the symptoms of the patient.\n\nThis pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.",[55,286,288,289,499,291,29,287],"Urinary",[55,29,293,294,295],"2025-03-26",{"date":503,"type":37},"2025-03-27",{"date":505,"type":37},"2025-03-20",{"date":507,"type":21},"2028-03-20",{"name":304,"class":177},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":531},"100437429","phase-3-skeletal-muscle-derived-cell-implantation-for-treatment-of-fecal-incontinence-100437429","NCT04976153","Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence","Skeletal Muscle-derived Cell Implantation for the Treatment of Fecal Incontinence: a Phase III, Randomized, Controlled, Double Blind, Two Armed Clinical Study","Fidelia","Inclusion Criteria:\n\n* Patients must be at least 18 years old\n* Patients who are mentally competent and able to understand all study requirements\n* Female patients of childbearing potential willing to use appropriate methods of contraception\n* Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months\n* Urge fecal incontinence episodes that occur more than twice a week\n* Maximal incremental voluntary squeeze pressure (increase to resting pressure) on anal manometry is 100mmHg or less in women and 150mmHg or less in men\n* 9\\. Ultrasound of the anal canal showing intact external anal sphincter or a maximal overall extent of external anal sphincter injury and tear of 180 degrees\n\nExclusion Criteria:\n\n* Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction.\n* Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound\n* Patients who underwent any anorectal surgery within 6 months before screening visit\n* Patients who underwent a total of two or more external anal sphincter-related surgeries\n* Patients who currently have anal fistulas or fissures or have recurrent anal fistulas or fissures\n* Patients with poorly controlled chronic constipation including obstructed defecation syndrome\n* Patients with indications against a surgery under anesthesia\n* Patients with a malignant disease not in remission for 5 years or more\n* Patients who have undergone radiation therapy of the bowel and pelvis\n* Patients who have undergone chemotherapy within last 5 years prior to study enrolment and\u002For chemotherapy related neuropathy of the bowel and pelvis\n* Patients with compromised immune system and\u002For rheumatic disease, and patients under immunosuppressive therapy\n* Patients with a diagnosis of chronic inflammatory bowel disease (e.g Crohn's disease, Colitis Ulcerosa)\n* Patients suffering from a disease which has not been resolved within 4 weeks prior to screening including fever and\u002For diarrhea of unknown reasons (4 weeks)\n* Patients diagnosed with human immunodeficiency virus (HIV), acute or chronic viral hepatitis HCV, acute or chronic viral hepatitis HBV, active Syphilis or HTLV (tested upon risk assessment by investigator)\n* Patients diagnosed with any kind of skeletal muscle disease and\u002For neuronal disorders\n* Patients with severe myocardial disorders, irregular pulse or a pacemaker\n* Patients with implantations of metal components in the electrical stimulation treatment area\n* Patients with uncontrolled diabetes mellitus type I or II, or suffering from diabetic peripheral neuropathic pain\n* Patients with clinically relevant abnormal laboratory values judged by the responsible investigator as relevant for the study treatment",{"count":518,"type":21},290,[317],"The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and\u002For weakness.",[29],"2025-03-10",{"date":524,"type":37},"2025-03-12",{"date":526,"type":37},"2022-05-11",{"date":528,"type":21},"2027-07-31",{"name":530,"class":177},"Innovacell GmbH",31,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":540,"enrollmentInfo":541,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":542,"conditions":543,"keywords":548,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":426},"100559285","multidimensional-examination-of-patients-with-colorectal-and-anal-cancer-100559285","NCT06562140","Multidimensional Examination of Patients with Colorectal and Anal Cancer","Multidimensional Examination of Physical Activity, Functional Capacity, and Health Status in Patients with Colorectal and Anal Cancer","MECACP","Inclusion Criteria:\n\n* adult (18-80 years) patients with a diagnosis of colorectal or anal carcinoma\n\nExclusion Criteria:\n\n* Neuromuscular diseases\n* severe congenital musculoskeletal and other disorders,\n* severe psychiatric illness, lack of cooperation,\n* undergone other surgical procedures within the past year.","80 Years",{"count":232,"type":21},"The aim of our cross-sectional research is to assess changes in physical activity, functional capacity, and health status in individuals with colorectal and anal carcinoma using subjective measurement tools, with particular focus on those suffering from incontinence, through a cross-sectional study. Additionally, the research involves the Hungarian adaptation and validation of the quality of life questionnaire for colorectal cancer (EORTC QLQ-CR29), quality of life questionnaire for anal cancer (EORTC QLQ-AN27), and Fecal Incontinence Severity Index (FISI)\" questionnaires.",[544,545,546,29,547],"Colorectal Cancer","Anal Cancer","Physical Inactivity","Quality of Life",[549,550,551,552,212],"colorectal cancer","anal cancer","quality of life","physical activity","2025-01-20",{"date":555,"type":37},"2025-01-23",{"date":557,"type":37},"2024-08-15",{"date":559,"type":21},"2025-09-01",{"name":561,"class":44},"University of Pecs",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":568,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":72},"100574790","sacral-neuromodulation-and-faecal-incontinence-and-its-unknown-effect-on-the-external-anal-sphincter-100574790","NCT06763861","Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter","SFINX - Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter","SFINX","Phase 1\n\nInclusion Criteria:\n\n* ≥ 18 years of age\n* Male or female\n* Diagnosed with rectal cancer and receive treatment with abdominoperineal resection\n* Signed an informed consent\n\nExclusion Criteria:\n\n* Previous diagnosis of FI\n* Unable to speak and\u002For read Swedish to ensure informed consent\n* Tumour involving the sphincter complex or is in close connection\n\nPhase 2 and 3\n\nInclusion Criteria:\n\n* Diagnosed with FI and will receive treatment with sacral neuromodulation\n* Male or female\n* Signed an informed consent\n\nExclusion Criteria:\n\n* Unable to speak and\u002For read Swedish to ensure informed consent",{"count":571,"type":21},15,"This innovative project aims to investigate structures and morphology of the external anal sphincter (EAS) as well as the impact of sacral neuromodulation (SNM) on the EAS morphology and biochemistry among patients with faecal incontinence (FI).\n\nSNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown.\n\nThe aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI.\n\nThe research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision.\n\nThe second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device.\n\nThe last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM.\n\nThe histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.",[29],[29,575,576,577,578,547,579],"Sacral neuromodulation","Surgery","Pathology","Proctology","Health status","2025-01-07",{"date":582,"type":37},"2025-01-08",{"date":584,"type":37},"2024-12-09",{"date":586,"type":21},"2028-12",{"name":588,"class":44},"Umeå University",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":17,"minAge":595,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":602,"lastUpdatePostDateStruct":603,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":608,"locationsCount":4},"100458713","enema-device-for-children-with-spina-bifida-100458713","NCT05253196","Enema Device for Children With Spina Bifida","Inclusion Criteria:\n\n* Poor sphincter tone\n* Perform regular enemas for bowel management (due to fecal incontinence)\n* 2 - 30 years old\n\nExclusion Criteria:\n\n* Non English speakers\n* Prisoners\n* Pregnant women\n* Wards of state\n* Decisionally challenged adults","2 Years","30 Years",{"count":282,"type":21},[24],"The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado treats patients who suffer from many different colorectal issues such as anorectal malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer from fecal incontinence. The investigators have developed a week long bowel management program (BMP) that is offered every month to help these kids stay clean of stool in the underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows one to perform an enema once every day, clean their colon, and remain free of 'accidents'. Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP. The overall success rate for all patients who suffer from fecal incontinence is 95%, however the success rate for spina bifida patients is only 77%. The reason for this decrease in success is due to the lack of anal sphincter tone in spina bifida patients, which leads to inadvertent leakage and spillage of enema fluid and bowel content during enema administration. The purpose of this study is to create and test an enema administration device that improves upon current methods.",[601,29],"Spina Bifida","2024-10-10",{"date":604,"type":37},"2024-10-15",{"date":606,"type":21},"2025-06",{"date":460,"type":21},{"name":609,"class":44},"University of Colorado, Denver",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":620,"briefSummary":621,"conditions":622,"keywords":623,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":305},"100437171","evaluation-of-the-efficacy-and-safety-of-autologous-fat-injection-into-the-intersphincter-space-in-fecal-incontinence-a-randomized-placebo-controlled-cross-over-double-blind-trial-100437171","NCT04972799","Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial","AUTOGRAFI : Evaluation of the Efficacy and Safety of Autologous Fat Injection Into the Intersphincter Space in Fecal Incontinence: a Randomized, Placebo-controlled, Cross-over, Double-blind Trial","AUTOGRAFI","Inclusion Criteria:\n\n1. 18 years of age or older\n2. severe fecal incontinence characterized by at least one episode of weekly fecal incontinence\n3. failed rehabilitation and dietary management strategies\n4. who have failed\u002Fcontraindicated\u002Frefused sacral root neuromodulation (in the indication of fecal incontinence)\n5. having, for women of childbearing age, effective contraception throughout the study\n6. having given free, informed and written consent\n\nExclusion Criteria:\n\n1. unable or unwilling to undergo follow-up or symptomatic evaluation\n2. contraindication to general anesthesia\n3. contraindication to metronidazole (hypersensitivity and wheat allergy)\n4. significant pelvic static disorder\n5. active anal suppuration\n6. anal stenosis\n7. externalized rectal prolapse\n8. chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis)\n9. on anticoagulants or antiaggregants\n10. history of anal or rectal neoplasia\n11. coagulation anomaly, curative anticoagulation\n12. history of rectal surgery\n13. history of pelvic radiotherapy\n14. previous treatment with inert materials (hyaluronic acid, biosilicones, coaptitis) in the 5 years preceding inclusion\n15. allergy to lidocaine or contraindication to adrenaline\n16. protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant or breast-feeding woman, minor)\n17. participating in another interventional trial concurrently\n18. not covered by a social security system",{"count":619,"type":21},50,[24],"Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots. However, this strategy is insufficient in more than one patient out of three. The patient and the clinician are often at a loss and the therapeutic possibilities are limited to the use of evacuating enemas and\u002For a colostomy.\n\nThe practice of autologous fat injections was initially developed in plastic surgery. The studies that have evaluated the efficacy of autologous fat injections in fecal incontinence in men are preliminary and old isolated observations. However, they have shown an improvement in episodes of fecal incontinence and in sphincter parameters. In the field of proctology and autologous fat injections, 2 recent small open studies have evaluated the efficacy and morbidity of this therapy in the treatment of anal fistulas related to Crohn's disease.\n\nThe primary hypothesis of the work is that autografting adipose tissue into the intersphincteric space can decrease episodes of fecal incontinence in patients with severe fecal incontinence due to sphincter failure. The secondary hypotheses are that autograft of adipose tissue in the intersphincter space improves resting anal pressures, is a well-tolerated technique for patients, and may improve their quality of life.",[29],[624],"Autograft","2024-09-24",{"date":627,"type":37},"2024-09-25",{"date":629,"type":37},"2022-10-19",{"date":631,"type":21},"2027-11",{"name":633,"class":44},"Rennes University Hospital",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":22,"phases":645,"briefSummary":646,"conditions":647,"keywords":654,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":72},"100556381","effect-of-pelvic-rehabilitation-after-low-anterior-resection-for-cancer-rectum---a-randomised-controlled-trial-100556381","NCT06524362","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial","Effect of Pelvic Rehabilitation After Low Anterior Resection for Cancer Rectum. - A Randomised Controlled Trial (PERECARE TRIAL)","PERECARE","Inclusion Criteria:\n\n* Age: Adults aged 18 years or older.\n* Surgical Procedure: Have undergone Low Anterior Resection (LAR) for rectal cancer.\n* Cognitive Ability: Capable of understanding and completing the questionnaires effectively\n\nExclusion Criteria:\n\n* Medical History: History of proctitis, ulcerative colitis, or Crohn's disease.\n* Surgical Extent: Extensive resection (beyond Total Mesorectal Excision - TME) for\n* locally advanced (T4) tumors, patients undergoing APR.\n* Surgical Complications: History of anastomotic leakage.\n* Recent Physiotherapy: History of invasive physiotherapy within the past 6 months.\n* Mental or Physical Inabilities: Inability to undergo Pelvic Floor Rehabilitation due to mental or physical limitations","85 Years",{"count":644,"type":21},77,[24],"Study Purpose:\n\nThis study aims to understand how pelvic floor rehabilitation (PFR) after low anterior resection (LAR) surgery for rectal cancer affects bowel control and quality of life compared to usual care.\n\nBackground:\n\nRectal cancer and its treatments can significantly impact patients' lives, often causing bowel issues like frequent bowel movements, urgency, and incontinence. These problems, known as low anterior resection syndrome (LARS), affect 70-90% of patients and can last for over two years. (1,2)\n\nCurrent Knowledge:\n\nAdvances in treatments have improved survival rates and recovery. Despite improvements, many patients still experience bowel issues after surgery.\n\nPast studies show PFR can help, but they have limitations like small sample sizes and varied methods. (3-5)\n\nNeed for the Study:\n\nThere is a need for a well-designed study to confirm the benefits of PFR and to identify which patients benefit the most.\n\nStudy Design:\n\nThis study is a randomized controlled trial that will:\n\n* Compare PFR to usual care in patients after LAR surgery.\n* Focus on bowel control and quality of life.\n* Provide detailed insights to improve aftercare for rectal cancer patients.",[648,649,650,651,652,29,653],"Rectal Cancer","Rectum Neoplasm","Rectal Neoplasms","Rectal Adenocarcinoma","Low Anterior Resection Syndrome","Bowel Dysfunction",[655,656,657,658,659,660,661,662,663,664,665],"Pelvic Floor Rehabilitation","Low Anterior Resection","Ultra Low Anterior Resection","Rectal Cancer Surgery","Post operative care","Bowel function","Quality of life","Randomized controlled trial","Fecal Urgency","Pelvic Floor Muscle Training","Oncological outcomes","2024-07-23",{"date":668,"type":37},"2024-07-29",{"date":670,"type":21},"2024-08",{"date":672,"type":21},"2026-03",{"name":674,"class":44},"GEM Hospital & Research Center"]