[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607354":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":42,"locations":49,"responsibleParty":94,"collaborators":36,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":98,"sex":104,"minAge":105,"maxAge":36,"enrollmentInfo":106,"targetDuration":36,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":118,"whyStopped":36,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug Therapy Group","ACTIVE_COMPARATOR","Participants who are randomized to drug therapy will receive mirabegron 25mg at visit 2 (randomization visit).",[13],"Drug: mirabegron",{"label":15,"type":10,"description":16,"interventionNames":17},"Behavioral Therapy Group","Participants who are randomized to exercise-based behavioral therapy will receive a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.",[18],"Behavioral: Exercise-based behavioral therapy",{"label":20,"type":10,"description":21,"interventionNames":22},"Combined Drug and Behavioral Therapy Group","At 6 weeks post-randomization, participants will complete the ICIQ-OAB questionnaire. Participants reporting less than 2 points reduction will be re-randomized to either continue their initial treatment assignment or receive combination therapy by adding the alternate treatment strategy, thus participants initially treated with mirabegron will add behavioral therapy and participants initially treated with behavioral therapy will add mirabegron.",[13,18],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","mirabegron","Mirabegron is a beta-3-agonist, which acts upon the noradrenergic system and avoids the cognitive and gastrointestinal side effects of anticholinergic bladder relaxants.",[20,9],[30],"Myrbetriq",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BEHAVIORAL","Exercise-based behavioral therapy","The exercise-based behavioral therapy is a comprehensive training program administered individually by a trained nurse practitioner interventionist to address urinary incontinence and other lower urinary tract symptoms.",[15,20],null,[38],{"name":39,"affiliation":40,"role":41},"Elizabeth Camille Vaughan, MD MS","Atlanta VA Medical and Rehab Center, Decatur, GA","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Taressa Sergent","CONTACT","(404) 321-1611","5023","Taressa.Sergent@va.gov",[50,65,80],{"facility":40,"status":36,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Decatur","Georgia","30033-4004","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-84.29631,33.77483,{"lat":60,"lon":59},[63,64],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},{"name":39,"role":41,"phone":36,"phoneExt":36,"email":36},{"facility":66,"status":36,"city":67,"state":68,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA","Philadelphia","Pennsylvania","19104-4551",{"type":57,"coordinates":71},[72,73],-75.16362,39.95238,{"lat":73,"lon":72},[76],{"name":77,"role":45,"phone":78,"phoneExt":36,"email":79},"James F Morley, MD","215-823-5934","james.morley@va.gov",{"facility":81,"status":36,"city":82,"state":83,"zip":84,"country":54,"countryCode":55,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":57,"coordinates":86},[87,88],-111.89105,40.76078,{"lat":88,"lon":87},[91],{"name":92,"role":45,"phone":36,"phoneExt":36,"email":93},"Alayne Markland, DO","alayne.markland@va.gov",{"type":95,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100607354","phase-4-behavioral-andor-mirabegron-to-treat-urinary-symptoms-in-parkinson-disease-100607354",false,"NCT07187466","Behavioral and\u002For Mirabegron to Treat Urinary Symptoms in Parkinson Disease","Sequential Multiple Assignment Randomized Trial to Treat Urinary Symptoms in Parkinson Disease","SQUARE PD","Inclusion Criteria:\n\n* Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders\n* An ICIQ-OAB Symptom Score of 7 or higher, which indicates clinically significant symptoms of OAB, defined as presence of urinary urgency with or without urgency incontinence usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology\n\nExclusion Criteria:\n\n* Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of \\\u003C 18 or a telephone-MoCA score \\\u003C 13, which is the recommended diagnostic cut point for dementia in PD.\n* Previous intensive pelvic floor muscle exercise training\n* Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score of 10 or higher which could affect motivation to fully engage in the intervention\n* Use of an indwelling urinary catheter\n* Post-void residual urine measurement by bladder ultrasound of \\> 150 mL\n* Severe uterine prolapse past the vaginal introitus\n* Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of \\>9.0% within the last 3 months. Participants with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after improvement in diabetes control\n* Chronic renal failure and on hemodialysis\n* Genitourinary cancer with ongoing surgical or external beam radiation treatment\n* Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device\n* History of bladder-injection of botulinum toxin in the last 12 months\n* Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.\n* Hypersensitivity to drug class\n* Contraindication to the study drug (mirabegron) including history of acute urinary retention requiring catheterization\n* Current use of a bladder relaxant - permitted to enroll after one-week washout\n* Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended, and enrollment will depend on clearance by a urologist and agreement by the site PI that entry into the treatment protocol is not contraindicated\n* If on diuretic, dose should be stable for at least 4 weeks\n* If taking an alpha-blocker, dose should be stable for at least 4 weeks\n* If taking dutasteride or finasteride, dose should be stable for at least 6 months","ALL","18 Years",{"count":107,"type":108},146,"ESTIMATED","INTERVENTIONAL",[111],"PHASE4","The purpose of this study is to learn about different treatments for overactive bladder symptoms in Parkinson's Disease. The investigators want to find out if people who do not respond to one treatment (either behavioral or drug treatment) will respond to combined treatment. The investigators also want to find out what factors influence whether someone responds to the treatments.",[114,115],"Overactive Bladder","Parkinson Disease",[117,115],"Urinary Bladder, Overactive","NOT_YET_RECRUITING","2026-04-03",{"date":121,"type":122},"2026-04-06","ACTUAL",{"date":124,"type":108},"2026-07-01",{"date":126,"type":108},"2030-06-30",{"name":5,"class":6},3]