[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuspera Medical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,37,59],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100622443","freedom-registry---follow-up-revision-experience-and-evaluation-of-device-outcomes-metrics-100622443",false,"NCT07383688","FREEDOM Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics","Follow-up Revision Experience and Evaluation of Device Outcomes Metrics in Subjects Receiving Replacement of Traditional Sacral Neuromodulation (SNM) With the Neuspera SNM System","Inclusion Criteria:\n\n1. Currently have a traditional SNM device and has decided to have the device replaced with the Neuspera SNM System OR previously had an existing traditional SNM implant that was completely removed within the last year\n2. Is 22 years of age or older\n3. Had documented at least 50% improvement in UUI episodes on a bladder diary with either a stimulation trial or with their traditional system\n4. Is a good surgical candidate and qualified to receive the Neuspera SNM System per the device labeling\n5. Is capable of participating in all testing and follow-up clinic visits associated with this clinical study.\n\nExclusion Criteria:\n\n1. Has a contraindication for the Neuspera SNM System per the device labeling.\n2. Has plans to enroll or is currently enrolled in another investigational device or drug trial during his\u002Fher participation in this study","ALL","22 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.",[24],"Urinary Urge Incontinence","NOT_YET_RECRUITING","2026-03-03",{"date":28,"type":29},"2026-03-05","ACTUAL",{"date":31,"type":20},"2026-03",{"date":33,"type":20},"2026-10",{"name":35,"class":36},"Neuspera Medical, Inc.","INDUSTRY",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":58},"100611942","study-of-30-minute-stimulation-with-the-neuspera-sacral-neuromodulation-snm-system-100611942","NCT07247136","Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System","Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)","Inclusion Criteria:\n\n* Is male or female 22 years of age or older.\n* Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.\n* Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.\n* Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the study duration OR must be willing to maintain medication through the study duration.\n* Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.\n* Has a positive stimulation trial with a 50% reduction in UUI episodes.\n\nExclusion Criteria:\n\n* Has a contraindication for the Neuspera SNM System per the device labeling.\n* Has a hemoglobin A1c of \\>8%.\n* Has glucosuria.\n* Has diabetic neuropathy.\n* Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.\n* Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.\n* Has broken, blistered skin or compromised circulation in the area of the neurostimulator implant.\n* Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.\n* Has documented urinary retention within 6 months prior to the screening baseline visit date.\n* Has clinically significant bladder outlet obstruction.\n* Is currently undergoing or has previously undergone pelvic irradiation.\n* Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer.\n* Has current grade 3 or 4 pelvic organ prolapse including cystocele, rectocele, enterocele, procidentia or vaginal vault prolapse.\n* Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for the study duration.\n* Has received treatment of urinary symptoms with any botulinum neurotoxin type-A (BoNT-A) agent in the past 6 months; (e.g. obotulinumtoxinA, Botox,® abobotulinumtoxinA, Dysport® IncobotulinumtoxinA, Xeomin®).\n* Is a woman who is pregnant or planning to become pregnant during this clinical study or is a woman of child-bearing potential who is not using a medically acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with clear negative result.\n* Has previously had SNM therapy.\n* Has active implantable medical devices such as neurostimulators, drug pumps, pacemakers, or internal defibrillators since compatibility has not been assessed.",{"count":45,"type":20},30,"INTERVENTIONAL",[48],"NA","Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.\n\nThe objective of the study is to assess the effectiveness of 30-minutes daily therapeutic stimulation with the Neuspera System.",[24],"RECRUITING",{"date":28,"type":29},{"date":54,"type":29},"2025-11-19",{"date":56,"type":20},"2026-11",{"name":35,"class":36},1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":46,"phases":69,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100604076","post-approval-study-of-the-neuspera-sacral-neuromodulation-system-100604076","NCT07144813","Post-Approval Study of the Neuspera Sacral Neuromodulation System","Clinical Post- Approval Study of the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)","NSM-005","Inclusion Criteria:\n\n* Subjects in the SANS-UUI Phase I or Phase II study\n\nExclusion Criteria:\n\n* None",{"count":68,"type":20},116,[48],"Prospective, multi-center, single-arm, post-approval study is designed to assess the long-term safety and efficacy data of the Neuspera Sacral Neuromodulation (SNM) System following commercial approval of the Neuspera SNM System.\n\nParticipants in this study received intervention\u002Fimplanted in Phase I or Phase II of the Neuspera SANS\\_UUI (NSM-004) Study.",[72],"Urinary Urgency Incontinence",[74],"UUI","2026-02-02",{"date":77,"type":29},"2026-02-04",{"date":79,"type":29},"2025-09-03",{"date":81,"type":20},"2029-12",{"name":35,"class":36},20,""]