{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T19:19:02Z","timestamp":1789672742763,"version":"4.0.1"},"reference-count":18,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T00:00:00Z","timestamp":1678752000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004374","name":"Medtronic","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004374","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neurourology and Urodynamics"],"published-print":{"date-parts":[[2023,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStim<jats:sup>TM<\/jats:sup> Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6\u2010month follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB\u2010q) at baseline and follow\u2010up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device\u2010, procedure\u2010, or therapy\u2010related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB\u2010q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixty\u2010eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3\u2010 and 6\u2010month follow\u2010up visits, respectively. The OAB\u2010q HRQL demonstrated a statistically significant improvement from baseline to 3\u2010month follow\u2010up with an average increase of 33\u2009\u00b1\u200924 points (<jats:italic>n<\/jats:italic>\u2009=\u200967, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). The change was also observed at 6\u2010months with an average increase of 31\u2009\u00b1\u200923 points (<jats:italic>n<\/jats:italic>\u2009=\u200965) compared to baseline. Eighty\u2010two percent of subjects achieved the minimally important difference in HRQL score at 3\u2010 and 6\u2010month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3\u2010month (92.5%, 62\/67) and 6\u2010month (89%, 59\/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow\u2010up in UUI episodes\/day was \u22123.6 (95% CI: \u22124.7, \u22122.6; <jats:italic>n<\/jats:italic>\u2009=\u200962) at 3\u2010month and \u22123.7 (95% CI: \u22124.7, \u22122.7; <jats:italic>n<\/jats:italic>\u2009=\u200961) at 6\u2010month. Among subjects with urgency\u2010frequency (UF), the average change from baseline to follow up in voids\/day was \u22124.5 (95% CI: \u22126.3, \u22122.7; <jats:italic>n<\/jats:italic>\u2009=\u200952) at 3\u2010months and \u22124.4 (95% CI: \u22126.0, \u22122.7; <jats:italic>n<\/jats:italic>\u2009=\u200952) at 6\u2010month. The cumulative incidence of device\u2010, procedure\u2010, or therapy\u2010 related adverse events was 7.4% (5\/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB\u2010q HRQL score at 3\u2010month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM.<\/jats:p><\/jats:sec>","DOI":"10.1002\/nau.25171","type":"journal-article","created":{"date-parts":[[2023,3,14]],"date-time":"2023-03-14T14:19:59Z","timestamp":1678803599000},"page":"761-769","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6\u2010month results from the global postmarket ELITE study"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9454-4866","authenticated-orcid":false,"given":"Colin","family":"Goudelocke","sequence":"first","affiliation":[{"name":"Department of Urology Ochsner Medical Center  New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Xavier","sequence":"additional","affiliation":[{"name":"Urology Partners of North Texas  Arlington Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barry","family":"Pecha","sequence":"additional","affiliation":[{"name":"First Urology Jeffersonville Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Burgess","sequence":"additional","affiliation":[{"name":"Prisma Health Greenville South Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie\u2010A.","family":"Perrouin\u2010Verbe","sequence":"additional","affiliation":[{"name":"Department of Urology, Centre Hospitalier Universitaire de Nantes Nantes Universit\u00e9 Nantes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan","family":"Krlin","sequence":"additional","affiliation":[{"name":"Department of Urology Louisiana State University Health Sciences Center New Orleans Louisiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodi","family":"Michaels","sequence":"additional","affiliation":[{"name":"Center for Continence Care, Minnesota Urology Woodbury Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sagar","family":"Shah","sequence":"additional","affiliation":[{"name":"East Coast Institute for Research LLC Jacksonville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beno\u00eet","family":"Peyronnet","sequence":"additional","affiliation":[{"name":"Department of Urology Centre Hospitalier Universitaire de Rennes Rennes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stanley","family":"Zaslau","sequence":"additional","affiliation":[{"name":"Department of Urology West Virginia University Morgantown West Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myl\u00e8ne","family":"Champs","sequence":"additional","affiliation":[{"name":"Medtronic Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bianca","family":"Papi","sequence":"additional","affiliation":[{"name":"Medtronic Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Bittner","sequence":"additional","affiliation":[{"name":"Medtronic Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1507-7783","authenticated-orcid":false,"given":"Dean","family":"Elterman","sequence":"additional","affiliation":[{"name":"Division of Urology University of Toronto Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Victor","family":"Nitti","sequence":"additional","affiliation":[{"name":"Department of Urology and Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery University of California Los Angeles Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,3,14]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/JU.0000000000000309"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1464-410x.1999.00004.x"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1464-410X.2009.08371.x"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00192-011-1486-0"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2017.07.010"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/nau.23008"},{"key":"e_1_2_11_8_1","unstructured":"Medtronic system eligibility battery longevity specifications: Interstim systems. 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