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Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.",[9],null,[22,26],{"name":23,"affiliation":24,"role":25},"Mahreen Pakzad, MD","University College London Hospitals","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":29},"Gita Ghadimi, OD","Boston Scientific Corporation","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":20,"email":35},"Anna Selverian","CONTACT","714-262-1787","anna.selverian@bsci.com",{"name":37,"role":33,"phone":38,"phoneExt":20,"email":39},"Erum Shaikh","657-626-4310","Erum.Shaikh@bsci.com",[41,60,75,94,108],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Chicago","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-87.65005,41.85003,{"lat":53,"lon":52},[56,58],{"name":57,"role":33,"phone":20,"phoneExt":20,"email":20},"Rowena Shi",{"name":59,"role":25,"phone":20,"phoneExt":20,"email":20},"Kimberly Kenton, MD",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of Missouri","Columbia","Missouri","65211",{"type":50,"coordinates":66},[67,68],-92.33407,38.95171,{"lat":68,"lon":67},[71,73],{"name":72,"role":33,"phone":20,"phoneExt":20,"email":20},"Kaycee Mackanos",{"name":74,"role":25,"phone":20,"phoneExt":20,"email":20},"Raymond Foster, MD",{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Bradford Royal Infirmary","Bradford","West Yorkshire","BD96RJ","United Kingdom","UK",{"type":50,"coordinates":83},[84,85],-1.75206,53.79391,{"lat":85,"lon":84},[88,90,92],{"name":89,"role":33,"phone":20,"phoneExt":20,"email":20},"Karen Regan",{"name":91,"role":33,"phone":20,"phoneExt":20,"email":20},"Stephen Cox",{"name":93,"role":25,"phone":20,"phoneExt":20,"email":20},"Elizabeth Kidger, MD",{"facility":95,"status":43,"city":96,"state":78,"zip":97,"country":80,"countryCode":81,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Pinderfields Hospital","Wakefield","WF1 4DG",{"type":50,"coordinates":99},[100,101],-1.49768,53.68331,{"lat":101,"lon":100},[104,106],{"name":105,"role":33,"phone":20,"phoneExt":20,"email":20},"Toyin Familade",{"name":107,"role":25,"phone":20,"phoneExt":20,"email":20},"Ased Ali, MD",{"facility":109,"status":43,"city":110,"state":20,"zip":111,"country":80,"countryCode":81,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"University College London Hospital","London","W1G 8PH",{"type":50,"coordinates":113},[114,115],-0.12574,51.50853,{"lat":115,"lon":114},[118,120],{"name":119,"role":33,"phone":20,"phoneExt":20,"email":20},"Nadia Malabi",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":122,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100576754","pmcf-study-of-the-axonics-snm-system-model-5101-r20-for-the-indication-of-oab-100576754",false,"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","ALL","18 Years",{"count":133,"type":134},55,"ESTIMATED","INTERVENTIONAL",[137],"NA","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.",[140,141,142],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Overactive Bladder (OAB)","2026-06-11",{"date":145,"type":146},"2026-06-15","ACTUAL",{"date":148,"type":146},"2025-09-18",{"date":150,"type":134},"2031-10",{"name":5,"class":6},5]