[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467095":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":52,"responsibleParty":87,"collaborators":89,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":31,"enrollmentInfo":104,"targetDuration":31,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":31,"overallStatus":55,"whyStopped":31,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Anticholinergic bladder medication plus behavioral self-management education","ACTIVE_COMPARATOR","Tolterodine tartrate is a muscarinic receptor antagonist designed to treat urgency incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.",[13],"Drug: Tolterodine Tartrate ER",{"label":15,"type":10,"description":16,"interventionNames":17},"Beta-3-adrenergic agonist medication plus behavioral self-management education","Mirabegron, currently sold under the brand name Mybetriq by Astellas Pharma, is a selective beta-3-adrenergic receptor agonist approved for treatment of urgency urinary incontinence, urgency, and frequency associated with overactive bladder. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.",[18],"Drug: Mirabegron",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo medication plus behavioral self-management education","PLACEBO_COMPARATOR","Microcrystalline cellulose placebo encapsulated to appear identical to tolterodine and mirabegron medication will be prepared by a compounding pharmacy. Behavioral self-management education includes written education about timed urination, lifestyle changes, pelvic floor muscle exercises, and urge suppression.",[24],"Drug: Placebo",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Tolterodine Tartrate ER","Anticholinergic",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Mirabegron","Beta-3-adrenergic agonist",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Placebo","matching placebo pill",[20],[41],{"name":42,"affiliation":5,"role":43},"Alison Huang, MD, MAS, MPhil","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","415-514-8697","alison.huang@ucsf.edu",{"name":50,"role":46,"phone":31,"phoneExt":31,"email":51},"Ann Chang","ann.chang@ucsf.edu",[53,72],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Stanford University","RECRUITING","Palo Alto","California","94305","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-122.14302,37.44188,{"lat":65,"lon":64},[68],{"name":69,"role":46,"phone":70,"phoneExt":31,"email":71},"Leslee Subak, MD","650-723-5533","lsubak@stanford.edu",{"facility":73,"status":55,"city":74,"state":57,"zip":75,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University of California San Francisco","San Francisco","94115",{"type":62,"coordinates":77},[78,79],-122.41942,37.77493,{"lat":79,"lon":78},[82,83],{"name":42,"role":46,"phone":31,"phoneExt":31,"email":48},{"name":84,"role":46,"phone":85,"phoneExt":31,"email":86},"Claudia Vila Manes","415-885-7547","claudia.vilamanes@ucsf.edu",{"type":88,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[90],{"name":91,"class":92},"National Institute on Aging (NIA)","NIH","100467095","phase-4-treating-incontinence-for-underlying-mental-and-physical-health-100467095",false,"NCT05362292","TReating Incontinence for Underlying Mental and Physical Health","Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence","TRIUMPH","Inclusion Criteria:\n\n* Aged 60 years or older at the time of enrollment\n* Female sex at birth, without surgical or hormonal gender re-assignment therapy\n* Able to walk to the bathroom and use the toilet without assistance\n* Report urinary incontinence starting at least 3 months prior to screening\n* Report that at least half of incontinence episodes occur with a sudden or strong sensation of urgency\n* Report 2 or more urgency incontinence episodes over a 7-day period\n* Willing to provide informed consent and adhere to study procedures throughout the length of the study\n\nExclusion Criteria:\n\n* Prior clinician diagnosis of dementia, or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening cognitive evaluation\n* Current use of anticholinergic, beta-3-adrenergic agonist, or other medication designed to improve urgency incontinence symptoms, or use in the past 1 month\n* Initiation, discontinuation, or dose change of dementia medications (such as donepezil, galantamine, memantine, rivastigmine) in the past 1 month (but candidates on stable doses are eligible)\n* Initiation, discontinuation, or dose change of other drugs with strong anticholinergic effects (based on the Beers List) in the past 1 month (but candidates on stable doses are eligible)\n* Initiation, discontinuation, or dose change of other drugs that can affect urinary frequency, including diuretics, in the past 1 month (but candidates on stable doses are eligible)\n* Current urinary tract infection (UTI) based on screening urinalysis and culture (but candidates can re-present for re-screening after undergoing treatment for UTI)\n* History of allergy or sensitivity to either of the study medications or an ingredient in the placebo or study medication capsule\n* Severe hepatic impairment (Child-Pugh score B or greater) or renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) as a contraindication to both study medications\n* Current bladder obstruction or urinary retention (defined by symptoms suggesting difficulty emptying the bladder in addition to postvoid residual urine volume greater than 150 cc by portable bladder ultrasound)\n* Uncontrolled hypertension (based on measured systolic blood pressure greater than 180 or diastolic blood pressure greater than 110 mmHg) as a contraindication to beta-3-adrenergic therapy\n* Self-reported history of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon as contraindications for anticholinergic bladder therapy\n* Use of drugs with adverse interactions with one of the study medications in the past 1 month, including potent CYP3A4 inhibitors, hepatic enzyme metabolism inducers, narrow therapeutic index drugs metabolized by CYP2D6, or intention to start taking one of these medications during the study treatment period\n* History of bladder surgery, invasive intra-vesical therapy, or bulk bladder injections in the past 3 months (more remote surgery will not be exclusionary), or intention to undergo one of these procedures in the study treatment period\n* Use of other specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy overseen by certified practitioners) in the past 3 months (more remote therapy will not be exclusionary), or intention to undergo one of these procedures in the study treatment period\n* Inability to sign informed consent or complete questionnaires, interviews, or study testing in English\n* Other condition that would prevent the participant from completing study procedures, in the opinion of the investigators (e.g., uncontrolled psychosis)",true,"FEMALE","60 Years",{"count":105,"type":106},270,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.",[112,113,114,115,116,117],"Urinary Incontinence, Urge","Urinary Incontinence","Overactive Bladder","Incontinence, Urge","Incontinence, Urinary","Incontinence","2026-03-04",{"date":120,"type":121},"2026-03-06","ACTUAL",{"date":123,"type":121},"2022-10-04",{"date":125,"type":106},"2027-08-02",{"name":5,"class":6},2]