[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100421771":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":304,"collaborators":26,"id":306,"slug":307,"hasResults":308,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":26,"eligibilityCriteria":312,"healthyVolunteers":308,"sex":313,"minAge":314,"maxAge":26,"enrollmentInfo":315,"targetDuration":26,"studyType":318,"phases":319,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},{"fullName":5,"class":6},"Caldera Medical, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Desara® One","EXPERIMENTAL","Single Incision Sling",[13],"Device: Desara® One Single Incision Sling",{"label":15,"type":16,"description":17,"interventionNames":18},"Desara® Blue","ACTIVE_COMPARATOR","Transobturator Sling",[19],"Device: Desara® Blue Transobturator Sling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Desara® One Single Incision Sling","Single incision sling",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Desara® Blue Transobturator Sling","Standard mid-urethral sling",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Vicki Gail","CONTACT","818-483-7602","vgail@calderamedical.com",[38,63,80,97,114,131,147,164,185,202,219,236,253,270,287],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Valley Urogynecology Associates, Inc.","RECRUITING","Phoenix","Arizona","85016","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-112.07404,33.44838,{"lat":50,"lon":49},[53,57,60],{"name":54,"role":34,"phone":55,"phoneExt":26,"email":56},"Dawn Hill","(602) 788-1521","dhill@valleyurogyn.com",{"name":58,"role":34,"phone":26,"phoneExt":26,"email":59},"Mirna Lopez","mlopez@valleyurogyn.com",{"name":61,"role":62,"phone":26,"phoneExt":26,"email":26},"Shazia Malik, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":65,"city":66,"state":42,"zip":67,"country":44,"countryCode":45,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"University of Arizona College of Medicine","NOT_YET_RECRUITING","Tucson","85724",{"type":47,"coordinates":69},[70,71],-110.92648,32.22174,{"lat":71,"lon":70},[74,78],{"name":75,"role":34,"phone":76,"phoneExt":26,"email":77},"Shaman Hashim","520-626-5935","shamamhashim@obgyn.arizona.edu",{"name":79,"role":62,"phone":26,"phoneExt":26,"email":26},"llana Addis, MD",{"facility":81,"status":40,"city":82,"state":83,"zip":84,"country":44,"countryCode":45,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Urological Research Center Corp","Hialeah","Florida","33016",{"type":47,"coordinates":86},[87,88],-80.27811,25.8576,{"lat":88,"lon":87},[91,95],{"name":92,"role":34,"phone":93,"phoneExt":26,"email":94},"Isabel Lopez","786-431-2014","isabel@besturology.net",{"name":96,"role":62,"phone":26,"phoneExt":26,"email":26},"Edward L Gheiler, MD",{"facility":98,"status":40,"city":99,"state":100,"zip":101,"country":44,"countryCode":45,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Women's Health Care Associates P.A. dba Rosemark Women Care Specialists","Idaho Falls","Idaho","83404",{"type":47,"coordinates":103},[104,105],-112.03414,43.46658,{"lat":105,"lon":104},[108,112],{"name":109,"role":34,"phone":110,"phoneExt":26,"email":111},"Sydney Nelson","208-557-2924","snelson@rosemark.net",{"name":113,"role":62,"phone":26,"phoneExt":26,"email":26},"Ty Erickson, MD",{"facility":115,"status":40,"city":116,"state":117,"zip":118,"country":44,"countryCode":45,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"CMB Research, LLC","Newburgh","Indiana","47630",{"type":47,"coordinates":120},[121,122],-87.40529,37.94449,{"lat":122,"lon":121},[125,129],{"name":126,"role":34,"phone":127,"phoneExt":26,"email":128},"Laura Holder","812-853-3500","laura@drbasinski.com",{"name":130,"role":62,"phone":26,"phoneExt":26,"email":26},"Cindy Basinski, MD",{"facility":132,"status":40,"city":133,"state":134,"zip":135,"country":44,"countryCode":45,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"University of Louisville","Louisville","Kentucky","40202",{"type":47,"coordinates":137},[138,139],-85.75941,38.25424,{"lat":139,"lon":138},[142,145],{"name":143,"role":34,"phone":144,"phoneExt":26,"email":26},"Gena Sayat, LPN","502-588-4400",{"name":146,"role":62,"phone":26,"phoneExt":26,"email":26},"Sean Francis, MD",{"facility":148,"status":40,"city":149,"state":150,"zip":151,"country":44,"countryCode":45,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Mt. 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MD",{"type":305,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100421771","desara--one-single-incision-sling-522-study-100421771",false,"NCT04772131","Desara ® One Single Incision Sling 522 Study","Prospective, Post-market Study of the Desara® One Single Incision Sling vs. Desara® Blue Sling Implanted Via the Transobturator Route for the Treatment of Women With Stress Urinary Incontinence","Inclusion Criteria:\n\n1. Female ≥ 18 of age.\n2. Subject agrees that she is willing and able to return for all study related procedures and evaluations.\n3. Subject has provided signed informed consent.\n4. Subject has stress urinary incontinence (SUI) confirmed by either supine or standing cough stress test (CST) with bladder pre-fill to subjective fullness with 200-300 mL, or with bladder fullness confirmed via ultrasound.\n5. Subject has confirmed stress incontinence greater than urge incontinence per MESA questionnaire.\n6. Subject no longer has childbearing capacity or has a negative pregnancy test and has decided to cease childbearing. Childbearing capacity to be confirmed by documented history of:\n\n   1. A hysterectomy or\n   2. Tubal ligation or\n   3. Is otherwise incapable of pregnancy or has\n   4. Negative pregnancy test prior to study entry and has decided to cease childbearing\n7. Subject has been offered and either failed or refused alternative non-invasive SUI treatment options and has elected to proceed with a surgical intervention.\n8. Subject is eligible to undergo laparoscopic\u002Frobotic (with or without mesh) or vaginal (with or without mesh) apical, anterior or posterior prolapse concomitant surgical repair procedures (non-mesh).\n\nExclusion criteria:\n\n1. Subject reports baseline pelvic pain ≥ 2 on 10 point Numeric Rating Scale (NRS).\n2. Subject has a known neurological disease (with or without signs\u002Fsymptoms of neurogenic bladder).\n3. Subject has known pre-existing pain syndrome and\u002For has been evaluated by an interventional pain management physician.\n4. Subject has a history of chronic opioid, or narcotic use for:\n\n   1. pain or\n   2. any other specified reason\n5. Subject is on anti-coagulation therapy that cannot be suspended or adjusted for a minimum of 24-48 hours prior to planned sling implantation surgery.\n6. Subject is on chronic (\\> 3 months) systemic steroid treatment (except for inhalational use as indicated for pulmonary conditions).\n7. Subject has uncontrolled diabetes defined as A1c ≥ 7% or fasting serum glucose \\> 130mg\u002Fdl at screening\u002Fbaseline.\n8. Subject has an active lesion or skin infection of the perineum, urethra, or vagina as noted per visual pelvic exam.\n9. Subject has active UTI which requires treatment, as determined by the Investigator.\n10. Subject has pattern of recurrent UTIs, defined as ≥ 3 culture-proven UTIs during the 6-month period prior to surgery.\n11. Subject has a urethral obstruction or other anatomic defects of the urethra (inclusive of urethral diverticulum or stricture or bladder neck contracture).\n12. The subject has had:\n\n    1. any prior surgical stress urinary incontinence treatment or\n    2. any prior surgery on their urethra or\n    3. any prior surgery to distal anterior vaginal wall, including fistula repair or prior cystocele repair\n    4. any previous pelvic floor mesh use or complication\n13. Subject has any of the following confounding conditions:\n\n    1. bladder stones or tumors\n    2. pathology that in the opinion of the Investigator would compromise implant placement\n    3. pathology that would limit pelvic blood supply\n    4. pathology that would require chemotherapy and systemic use of immunosuppressants\n14. Subject has abnormal bladder capacity \\\u003C300 mL.\n15. Subject has a post void residual volume ≥ 150 mL on two different measurements. (Prolapse reduction during PVR measurement is only allowed if a prolapse repair will be performed concomitantly with the sling implantation)\n16. Subject has had previous radiation therapy or brachytherapy to the pelvis.\n17. Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function, interfere with clinical outcomes, or impact analysis of this device.\n18. Subject has known reaction, sensitivity or allergy to polypropylene.","FEMALE","18 Years",{"count":316,"type":317},300,"ESTIMATED","INTERVENTIONAL",[320],"NA","A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.",[323],"Stress Urinary Incontinence",[325,326,327,328,9,15],"stress urinary incontinence","female stress urinary incontinence","single incision sling","transobturator sling","2025-09-15",{"date":331,"type":332},"2025-09-19","ACTUAL",{"date":334,"type":332},"2021-11-01",{"date":336,"type":317},"2026-11",{"name":5,"class":6},15]