[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656590":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":45,"interventions":63,"overallOfficials":77,"centralContacts":81,"locations":90,"responsibleParty":115,"collaborators":117,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":34,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":129,"minAge":130,"maxAge":34,"enrollmentInfo":131,"targetDuration":34,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":34,"overallStatus":93,"whyStopped":34,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Change in nocturnal urination frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.","Frequency of nocturnal urination will be assessed using a standardized, 7-day voiding diary.","Baseline to 6 months",[14,16,19,22,25,28,31],{"measure":15,"description":11,"timeFrame":12},"Change in nocturnal urinary incontinence frequency over 6 months (24 weeks) of treatment, based on a validated voiding diary.",{"measure":17,"description":18,"timeFrame":12},"Change in global sleep quality score over 6 months (24 weeks) of treatment.","Perceived sleep quality will be assessed using the Pittsburgh Sleep Quality Index(PSQI), an 18-item validated questionnaire designed to assess sleep quality, latency, efficiency, and problems over a one-week period. Score range: 0-21, with higher scores indicating a worse outcome.",{"measure":20,"description":21,"timeFrame":12},"Change in daytime sleepiness score over 6 months (24 weeks) of treatment.","Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire assessing the level of general sleepiness during real-life situations in order to distinguish excessive daytime sleepiness from normal daytime sleepiness. Score range: 0-24, with higher scores indicating a worse outcome.",{"measure":23,"description":24,"timeFrame":12},"Change in sleep efficiency over 6 months (24 weeks) of treatment, based on the PSQI sleep efficiency score.","Sleep efficiency will be assessed based on questions 1, 3, and 4 of the Pittsburgh Sleep Quality Index (PSQI). Score range: 0-3, with higher scores indicating a worse sleep efficiency.",{"measure":26,"description":27,"timeFrame":12},"Change in depression symptoms over 6 months (24 weeks) of treatment.","Depression symptoms will be assessed using the 15-item short form of the GeriatricDepression Scale-15 (GDS-15), which assesses symptoms of depression over a 1-week period. Score range: 0-24, with higher scores indicating a worse outcome. Score range: 0-15, with higher scores indicating a worse outcome.",{"measure":29,"description":30,"timeFrame":12},"Change in anxiety symptoms over 6 months (24 weeks) of treatment.","Anxiety symptoms will be assessing using the Generalized Anxiety Disorder-7 (GAD7),7-item short form, questionnaire to assess severity of anxiety symptoms over a 2-week period. Score range: 0-21, with higher scores indicating a worse outcome.",{"measure":32,"description":33,"timeFrame":12},"Change in composite cognitive function over 6 months (24 weeks) of treatment, using a composite cognitive score that incorporates normalized data from all domain-specific cognitive tests.","The composite cognitive score will be calculated as the average of Z-scores from the following individual cognitive tests: a) Auditory Verbal Learning Test (AVLT); b) Oral Trail Making Test (OTMT) part A; c) OTMT part B; d) Digit Span Test; and e) Digit Symbol Substitution Test (DSST). The normative mean of each cognitive test will be subtracted from each participant's component test score, and this difference will be divided by the standard deviation for the appropriate normative sample. After scores from individual tests are transformed to Z scores as a common metric based on normative data, the average Z score from all available tests will be calculated to provide a composite Z score.",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"TRIPLE",[42,43,44],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,52,57],{"label":47,"type":48,"description":49,"interventionNames":50},"Anticholinergic bladder medication plusbehavioral 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 urge suppression",[51],"Drug: TolterodineTartrate ER",{"label":53,"type":48,"description":54,"interventionNames":55},"Beta-3-adrenergic agonist medication plusbehavioral 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.",[56],"Drug: Mirabegron",{"label":58,"type":59,"description":60,"interventionNames":61},"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 time duration, lifestyle changes, pelvic floor muscle exercises, and urge suppression.",[62],"Drug: Placebo",[64,69,73],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":34},"DRUG","TolterodineTartrate ER","Anticholinergic",[47],{"type":65,"name":70,"description":71,"armGroupLabels":72,"otherNames":34},"Mirabegron","Beta-3-adrenergic agonist",[53],{"type":65,"name":74,"description":75,"armGroupLabels":76,"otherNames":34},"Placebo","matching placebo pill",[58],[78],{"name":79,"affiliation":5,"role":80},"Alison Huang, MD","PRINCIPAL_INVESTIGATOR",[82,87],{"name":83,"role":84,"phone":85,"phoneExt":34,"email":86},"Alison Huang, MD, MAS, MPhil","CONTACT","(415) 514-8697","alison.huang@ucsf.edu",{"name":88,"role":84,"phone":34,"phoneExt":34,"email":89},"Ann Chang","ann.chang@ucsf.edu",[91],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"University of California San Francisco","RECRUITING","San Francisco","California","94115","United States","US",{"type":100,"coordinates":101},"Point",[102,103],-122.41942,37.77493,{"lat":103,"lon":102},[106,110,114],{"name":107,"role":84,"phone":108,"phoneExt":34,"email":109},"Claudia Vila Manes","415-885-7547","claudia.vilamanes@ucsf.edu",{"name":111,"role":84,"phone":112,"phoneExt":34,"email":113},"Amy Zhang","(415) 885-7547","amy.zhang4@ucsf.edu",{"name":79,"role":80,"phone":34,"phoneExt":34,"email":34},{"type":116,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[118],{"name":119,"class":120},"National Institute on Aging (NIA)","NIH","100656590","phase-4-ancillary-nocturnal-urinary-symptoms-analyses-for-triumph-100656590",false,"NCT07829029","Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH","Ancillary Nocturnal Urinary Symptom Investigation in the TRIUMPH Trial","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":132,"type":133},270,"ESTIMATED","INTERVENTIONAL",[136],"PHASE4","The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed tocompare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonistbladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinaryincontinence and either normal or mildly impaired cognitive function at baseline.",[139],"Nocturia","2026-09-18",{"date":142,"type":143},"2026-09-22","ACTUAL",{"date":145,"type":143},"2022-10-04",{"date":147,"type":133},"2027-05-02",{"name":5,"class":6},1]