[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-urge-incontinence-uui\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-urge-incontinence-uui":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,59,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171",false,"NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"NA","Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[26,27,28,29],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[31,32,33],"Peripheral nerve evaluation","External trial system","Pilot study","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-04-30",{"date":42,"type":20},"2026-12",{"name":44,"class":45},"Axonics, Inc.","INDUSTRY",2,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":24,"conditions":51,"keywords":52,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":58,"locationsCount":46},"100618735",{"count":19,"type":20},[23],[26,27,28,29],[31,32,33],"2026-06-11",{"date":55,"type":38},"2026-06-15",{"date":40,"type":38},{"date":42,"type":20},{"name":44,"class":45},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100576754","pmcf-study-of-the-axonics-snm-system-model-5101-r20-for-the-indication-of-oab-100576754","NCT06789406","PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB","Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)","Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of OAB (urinary urgency incontinence (UUI) \u002F urinary frequency (UF) who are not candidates for, or who have failed conservative treatment\n3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments\n\nExclusion Criteria:\n\n1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)\n2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements\n3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)\n4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n5. A female who is breastfeeding\n6. A female with a positive urine pregnancy test",{"count":67,"type":20},55,[23],"Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.",[26,27,29],{"date":55,"type":38},{"date":73,"type":38},"2025-09-18",{"date":75,"type":20},"2031-10",{"name":44,"class":45},5,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":86,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100577357","approve-trial-evaluating-a-prescription-digital-therapeutic-for-treatment-of-oab-in-women-100577357","NCT06797245","APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women","The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women","APPROVE","Inclusion Criteria:\n\n* Women ≥ 22 years old\n* Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)\n* English-speaking\n* Willing to forego other treatment outside of medications for the 8-week trial period\n* Use of at least one mobile App\n\nExclusion Criteria:\n\n* Stress-predominant mixed urinary incontinence (defined as QUID stress score \\> QUID urge score)\n* Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a\n* Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a\n* Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks\n* Currently using intermittent or indwelling catheter\n* History of bladder\u002Furethral, colon\u002Fanal, or cervical cancer\n* Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection\n* Currently taking antibiotics\u002Fdrugs for urinary tract infection\\^\n* Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period\n* Planning surgery for pelvic organ prolapse within 12 months of randomization\n* Pelvic surgery within the past 6 months\n* Planning to undergo pessary fitting °\n\n  * Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting\n\nhttps:\u002F\u002Fresearchdata.medstar.net\u002Fredcap\u002Fsurveys\u002F?s=MM7WN7EXACX4PNXJ","FEMALE","22 Years",{"count":89,"type":20},596,[23],"The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).",[29,93,26,94,95],"Urinary Urgency","Nocturia","Urinary Frequency",[29],"2025-10-24",{"date":99,"type":38},"2025-10-27",{"date":101,"type":38},"2025-03-17",{"date":103,"type":20},"2028-07",{"name":105,"class":106},"Medstar Health Research Institute","OTHER",10]