[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bright Uro\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"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":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100630248","establishing-normative-urodynamics-parameters-for-the-glean-urodynamics-system-in-healthy-adults-100630248",false,"NCT07485205","Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults","Inclusion Criteria:\n\n1. Healthy male and female adults ages 18 to 45 years.\n2. Patient is able to read, write, and communicate in English.\n3. Patient is able to provide informed consent.\n4. Patient owns, can independently operate, and is willing to use a smart device for study data collection purposes\n\nExclusion Criteria:\n\n1. Patient with any prior pregnancy (gravida ≥1), is currently pregnant (as confirmed by urine pregnancy test or medical history), or intends to become pregnant during the study period.\n2. Patient has one or more symptoms indicative of a symptomatic urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and\u002For dysuria).\n3. Patient has a known history of urological conditions (e.g., recurrent UTIs, incontinence, symptomatic benign prostatic hyperplasia, neurogenic bladder, interstitial cystitis, urinary retention, any genitourinary cancer).\n4. Patient has a known history of neurological conditions that can affect central nervous system function.\n5. Patients with a current or prior diagnosis of diabetes mellitus (Type 1 or Type 2).\n6. Patient is currently taking medications that may affect urological functions (e.g., diuretics, anticholinergics, alpha-blockers).\n7. Patient has abnormal urinary habits if one or more of the following bladder events are reported on any day of the 3-day bladder diary: urinary frequency ≥ 8 times\u002Fday, ≥ 1 nocturia episode, ≥ 1 leak event, or ≥ 1 urgency event.\n8. Patient has a total score on the Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10) questionnaire greater than 0; a total score of 1 is acceptable only if the sole positive response is urinary frequency of 4-7 times per day.\n9. Patient has a urostomy and\u002For colostomy.\n10. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and\u002For bladder wall) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures).\n11. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).\n12. Patient would not be appropriate for this study as determined by the Principal Investigator.",true,"ALL","18 Years","45 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"NA","A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.",[27],"Lower Urinary Tract Symptoms (LUTS)","RECRUITING","2026-04-17",{"date":31,"type":32},"2026-04-22","ACTUAL",{"date":34,"type":32},"2026-03-31",{"date":36,"type":21},"2027-03",{"name":38,"class":39},"Bright Uro","INDUSTRY",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":61,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100625621","ambulatory-long-length-urodynamics-evaluation-100625621","NCT07425015","Ambulatory Long Length URodynamics Evaluation","ALLURE","Inclusion Criteria:\n\n1. Male or female patient must be ≥ 22 years of age.\n2. Patient is a candidate for UDS per standard of care.\n3. Patient is able to provide informed consent.\n\nExclusion Criteria:\n\n1. Patient has one or more symptoms indicative of a urinary tract infection (UTI) (i.e., fever, costovertebral angle pain or tenderness, suprapubic tenderness, worsening urinary frequency, worsening urgency, and\u002For dysuria).\n2. Patient has a history of recurrent UTIs (≥ 3 episodes in previous 12 months).\n3. Patient has used antibiotics within the past 7 days from the baseline\u002Fscreening visit.\n4. Patient diagnosed with neurogenic LUTD (i.e., one or more of these conditions: normal-pressure hydrocephalus, cerebral palsy, spinal cord injuries, traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, meningomyelocele, spina bifida, dementia, Guillain-Barre syndrome, and tumors involving the central nervous systems or spine).\n5. Patient diagnosed with interstitial cystitis (IC), bladder pain syndrome, painful bladder syndrome or any etiology of chronic pelvic pain syndrome (CPPS).\n6. Patient with a urostomy.\n7. Patient with a colostomy.\n8. Patient has an atypical anatomic structural variation or has had a previous surgical intervention that has permanently changed structural anatomy anywhere along their lower urinary tract (urethra, pelvic floor, urethral sphincter, and\u002For bladder wall) that the principal investigator deems might compromise the placement or retention of the Glean sensors during the study (e.g., strictures).\n9. Patient has a Pelvic Organ Prolapse Quantification (POP-Q) of Grade III or higher (i.e., most distal portion of the prolapse protrudes more than 1 centimeter below the hymen).\n10. Patient with any abnormal or concerning rectal conditions such as ongoing anal fissures, rectocele, fistula, active herpes, or active yeast infections.\n11. Patient has a known inability to void.\n12. Patient has a previous history of radiation leading to bleeding (e.g., hemorrhagic radiation cystitis).\n13. Patient is pregnant (as confirmed by urine pregnancy test or medical history) or breastfeeding, pregnant within the past 6 months, or intending to become pregnant during the study period.\n14. Patients who may not be able to independently use a smart device.\n15. Subjects who, at the principal investigator's determination, would not be appropriate for this study.","22 Years",{"count":50,"type":21},101,[24],"A prospective, open-label, single arm interventional trial evaluating the safety and performance of the in-clinic and extended monitoring of the lower urinary tract using the Glean Urodynamics System.",[54,55,56,57,58,59,60],"Urology","Urinary Bladder, Overactive","Benign Prostatic Hyperplasia","Urodynamics","Home Monitoring","Urinary Incontinence (UI)","Lower Urinary Tract Dysfunction",[38,62,63],"Glean Urodynamics System","Uroflowmetry","2026-04-13",{"date":66,"type":32},"2026-04-15",{"date":68,"type":32},"2026-02-17",{"date":70,"type":21},"2027-06",{"name":38,"class":39},7,""]