[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Axonics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":136},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,73,98,108,126],{"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":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100053817","sacral-neuromodulation-for-male-overactive-bladder-moab-100053817","NCT06511141","Sacral Neuromodulation for Male Overactive Bladder (MOAB)","Sacral Neuromodulation for Male Overactive Bladder","Key Inclusion Criteria:\n\n1. Participants aged ≥ 18 years at the time of enrollment\n2. Able to complete bladder diaries and patient questionnaires\n3. Primary diagnosis of OAB (urinary urgency incontinence (UUI) or urinary frequency (UF)).\n4. Willing and capable to provide written informed consent and agrees to comply with specified evaluations at clinical investigational sites and attend all follow-up assessments for up to 1 year\n\nKey Exclusion Criteria:\n\n1. Any patient that is not a suitable candidate per investigator discretion\n2. Recent prostate therapy or procedure within the last 6 months at the time of enrollment\n3. Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)\n4. Previously implanted with a sacral neuromodulation device, including inactive SNM devices\n5. Any prior treatment with an Implantable Tibial Nerve Stimulation (ITNS)\n6. Positive response to Percutaneous Tibial Nerve Stimulation (PTNS) within the last 3 months at the time of enrollment\n7. Underwent an external trial with any sacral neuromodulation device and was deemed a non-responder by a physician\n8. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives at the discretion of the participating physician.\n9. Uncontrolled diabetes\n10. Known allergic reactions to components of the Axonics SNM System, including titanium, zirconia, polyurethane, epoxy, or silicone","MALE",{"count":56,"type":20},150,[23],"To assess the post-market clinical outcomes of the Axonics SNM System for treatment of overactive bladder in male patients.",[60,61,62,63,64,65],"Overactive Bladder","Urinary Urgency Incontinence","Benign Prostatic Hyperplasia","Prostate Cancer","Prostatectomy","Urinary Frequency",{"date":37,"type":38},{"date":68,"type":38},"2024-10-22",{"date":70,"type":20},"2028-12",{"name":44,"class":45},21,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100631329","axonics-r20-post-market-clinical-follow-up-pmcf-study-for-the-indication-of-fecal-incontinence-100631329","NCT07499258","Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence","Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System INS Model 5101 (R20) for the Indication of Fecal Incontinence (FI)","Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of Fecal Incontinence (FI)\n3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers\n\nExclusion Criteria:\n\n1. Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis)\n2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements\n3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n4. A female who is breastfeeding\n5. A female with a positive urine pregnancy test",{"count":81,"type":20},55,"OBSERVATIONAL","Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.",[85],"Fecal Incontinence",[85,87],"Sacral Neuromodulation","NOT_YET_RECRUITING","2026-06-11",{"date":91,"type":38},"2026-06-15",{"date":93,"type":20},"2026-06",{"date":95,"type":20},"2029-12",{"name":44,"class":45},1,{"id":99,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":24,"conditions":102,"keywords":103,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":106,"leadSponsor":107,"locationsCount":46},"100618735",{"count":19,"type":20},[23],[26,27,28,29],[31,32,33],{"date":91,"type":38},{"date":40,"type":38},{"date":42,"type":20},{"name":44,"class":45},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"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":81,"type":20},[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":91,"type":38},{"date":121,"type":38},"2025-09-18",{"date":123,"type":20},"2031-10",{"name":44,"class":45},5,{"id":127,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":58,"conditions":130,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":133,"leadSponsor":134,"locationsCount":135},"100555365",{"count":56,"type":20},[23],[60,61,62,63,64,65],{"date":91,"type":38},{"date":68,"type":38},{"date":70,"type":20},{"name":44,"class":45},20,""]