[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478299":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":67,"collaborators":12,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":12,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":12,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":12,"overallStatus":51,"whyStopped":12,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Indiana University","OTHER",[8,13,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1a: in-person clinical assessment of LUTS\u002FBPH","NO_INTERVENTION","COHORT 1a: Subjects randomized to undergo in-person initial clinical workup of Lower Urinary Tract Symptoms (LUTS) \u002F Benign Prostatic Hyperplasia (BPH) and in-person clinical follow-up after 3 months of clinical intervention. In-person clinical workup at both the initial and Month 3 follow-up timepoint includes International Prostate Symptom Score (IPSS), and standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA) assessments.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Cohort 1b: virtual (telehealth) clinical assessment of LUTS\u002FBPH","EXPERIMENTAL","COHORT 1b: Subjects randomized to undergo virtual initial clinical workup of Lower Urinary Tract Symptoms (LUTS) \u002F Benign Prostatic Hyperplasia (BPH) and virtual clinical follow-up after 3 months of clinical intervention. Virtual clinical workup at both the initial and Month 3 follow-up timepoint includes at home completion of International Prostate Symptom Score (IPSS), at home uroflowmetry assessment through use of the Stream Dx device, at home assessment of post void residual (PVR) through use of the DFree device, and at home urinalysis (UA) through use of the TestCard device.",[18,19,20],"Device: Stream Dx","Device: DFree","Device: TestCard",{"label":22,"type":6,"description":23,"interventionNames":24},"Cohort 2: Validation Cohort","COHORT 2: Non-randomized subjects who will attend a single, clinically scheduled, in-person follow-up appointment to directly compare the standard of care assessments\u002Fdevices to the experimental assessments\u002Fdevices. Prior to the in-person appointment, patients will complete at home uroflowmetry assessment through use of the Stream Dx device. At the in-person appointment, the clinic staff will perform standard of care uroflowmetry, post void residual (PVR), and urinalysis (UA). At this visit, clinic staff will also obtain PVR measurements through use of the DFree device and urinalysis through the TestCard device.",[18,19,20],[26,31,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"DEVICE","Stream Dx","home uroflowmetry device",[14,22],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":12},"DFree","at home wearable bladder scanner",[14,22],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":12},"TestCard","mobile urinalysis reader",[14,22],[40],{"name":41,"affiliation":5,"role":42},"Marcelino Rivera, MD","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":48},"Stephanie Woffard, MSM","CONTACT","(317) 695-7585","sdwillia@iu.edu",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-86.15804,39.76838,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":12,"email":48},"Stephanie Wofford, MSM","317-695-7585",{"type":42,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Marcelino Rivera","Assistant Professor, IU Department of Urology","100478299","patient-satisfaction-of-virtual-vs-in-person-workup-and-treatment-of-lower-urinary-tract-symptoms-100478299",false,"NCT05508165","Patient Satisfaction of Virtual vs In-Person Workup and Treatment of Lower Urinary Tract Symptoms.","IRB: #12530 Prospective, Randomized Study to Assess Clinical Outcomes and Patient Satisfaction of Virtual vs. In-Person Workup and Treatment of Lower Urinary Tract Symptoms","Inclusion Criteria\n\n* ≥18 years of age\n* New patient referral for urinary retention, BPH, or LUTS (Cohort 1)\n* Established patient for urinary retention, BPH, or LUTS (Cohort 2)\n* Male\n\nExclusion Criteria\n\n* \\\u003C18 years of age\n* Inability to provide informed consent\n* Visually or hearing impaired\n* Concomitant condition requiring in-person exam or evaluation\n* History of allergic reaction or issues with ultrasound gel",true,"ALL","18 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study is being done to compare usefulness of data collected in uroflowmetry, a test that measures the amount of urine released from the body, at home versus in the doctor's office. Additionally, investigators are assessing patient satisfaction when completing a virtual visit for lower urinary tract symptoms (LUTS), related to prostatic enlargement, compared to an in person visit.\n\nThe three devices being investigated have not been used in the home setting to make urinary measurements as is typically done in clinic. The goal is to test the effectiveness and accuracy of these devices compared to our standard clinical practices and demonstrate their ability to provide useful information in the home setting.",[88],"Urologic Diseases","2025-03-11",{"date":91,"type":92},"2025-03-13","ACTUAL",{"date":94,"type":92},"2022-08-30",{"date":96,"type":82},"2026-12-30",{"name":5,"class":6},1]