[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dyssynergic-defecation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dyssynergic-defecation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100610301","management-of-dyssynergic-defecation-100610301",false,"NCT07225803","Management of Dyssynergic Defecation","Inclusion Criteria:\n\n* Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study\n* Satisfy Rome III criteria for functional constipation and\u002For irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing\n\nExclusion Criteria:\n\n* Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and\u002For pose safety concerns.\n* History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.\n* Current anal fissure\n* Clinically significant structural abnormalities (eg, rectocele \\> 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms\n* Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation\n* Pregnant or nursing women, prisoners and institutionalized individuals\n* BMI \\>35 kg\u002Fm2\n* Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued them for at least 1 week before the date of screening and are willing to stay off them for the duration of the study.\n* Current use of anticholinergics (eg. amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline or amitriptyline up to 50 mg\u002Fday) will be eligible provided they do not increase the dose during the study period. Patients on higher doses are eligible to participate if it is safe and they are willing to reduce their medication dose at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.\n* Current use of laxatives (Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete (As detailed later, all participants can use Miralax throughout the study).\n* Any other factors that increase the risk to participants of participating in the study and\u002For undermine the integrity of the data.","ALL","18 Years","80 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this research is to better understand constipation and improve biofeedback treatments.",[26,27],"Dyssynergic Defecation","Constipation","RECRUITING","2025-11-05",{"date":31,"type":32},"2025-11-10","ACTUAL",{"date":34,"type":32},"2025-07-18",{"date":36,"type":20},"2029-07",{"name":38,"class":39},"Mayo Clinic","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100498541","home-biofeedback-therapy-for-dyssynergic-defecation-fecal-incontinence-and-urinary-incontinence-100498541","NCT05771597","Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence","Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study","Bioanatoner","Inclusion Criteria:\n\n* Inclusion Criteria for patients with constipation and dyssynergic defecation\n\n  1. Minimum age of 18 years\n  2. Meet Rome IV criteria for functional constipation (≥ 2 of following 6 symptoms) with symptom onset of 6 months on prospective stool diary\n* Straining with 25% of bowel movements (BM)\n* Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM\n* Sensation of incomplete evacuation with 25% of BM\n* Sensation of anorectal obstruction\u002Fblockage with 25% of BM\n* Manual maneuvers to facilitate defecation with 25% of BM\n* \\\u003C 3 Spontaneous bowel movements per week 3. Patients must demonstrate dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.\n\n  * Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria:\n  * Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute.\n  * Prolonged colonic transit time on wireless motility capsule (\\>59 hours) or \\>5 markers retained on a colonic transit study.\n  * Inability to evacuate or ≥ 50% retention of barium during defecography.\n\nInclusion Criteria for patients with fecal incontinence\n\n1. Minimum age of 18 years\n2. Recurrent episodes of fecal incontinence for six months\n3. No colonic mucosal disease\n4. On a two-week, prospective stool diary, patient reports at least one episode of fecal incontinence per week\n\nInclusion Criteria for patients with urinary incontinence\n\n1. Minimum age of 18 years\n2. Recurrent episodes of urinary incontinence for three months\n3. Stress, urge or mixed urinary incontinence, with at least 2 episodes of urinary incontinence on a 14-day urinary incontinence diary\n\nExclusion Criteria:\n\n* Exclusion criteria for patients with constipation and dyssynergic defecation\n\n  1. Evidence of structural or metabolic disease that could cause constipation, as assessed by colonoscopy or barium enema and routine hematological, biochemical, and thyroid function tests\n  2. Use of opioids within the previous 2 weeks\n  3. Severe cardiac or renal disease\n  4. Neurological diseases such as multiple sclerosis or stroke\n  5. Rectal prolapse or active anal fissures\n  6. Alternating pattern of constipation and diarrhea\n  7. Pregnant women or nursing mothers\n* Exclusion criteria for patients with fecal incontinence Severe diarrhea with Bristol Stool consistency ≥ Type 6 2. On opioids (except on stable doses \\> 3months) 3. Active depression 4. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe Chronic Obstructive Pulmonary Disease (COPD) 5. Ulcerative and Crohn's colitis 6. Rectal prolapse or active anal fissure 7. Pregnant women or nursing mothers\n* Exclusion criteria for patients with urinary incontinence\n\n  1. Continuous urine leakage\n  2. Active depression\n  3. Comorbid illnesses, severe cardiac disease, chronic renal failure or severe COPD\n  4. Rectal prolapse or active anal fissure\n  5. Pregnant women or nursing mothers",{"count":50,"type":20},72,[23],"Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies.\n\nThe purpose of this study is to\n\n1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system\n2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy\n3. To assess the cost-effectiveness of home biofeedback therapy.",[54,26,55],"Fecal Incontinence","Urinary Incontinence",[57,58,59,60,61],"home biofeedback therapy","office biofeedback therapy","fecal incontinence","dyssynergic defecation","urinary incontinence","2023-03-14",{"date":64,"type":32},"2023-03-16",{"date":66,"type":20},"2023-03-27",{"date":68,"type":20},"2026-12-31",{"name":70,"class":39},"Augusta University"]