[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552987":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":26,"centralContacts":22,"locations":34,"responsibleParty":161,"collaborators":163,"id":179,"slug":180,"hasResults":181,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":181,"sex":187,"minAge":188,"maxAge":22,"enrollmentInfo":189,"targetDuration":22,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":200,"overallStatus":37,"whyStopped":22,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"NICHD Pelvic Floor Disorders Network","NETWORK",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Solyx Single-incision Sling","ACTIVE_COMPARATOR",[12],"Device: Solyx Single-incision Sling",{"label":14,"type":10,"description":14,"interventionNames":15},"Bulkamid Transurethral Bulking Agent",[16],"Device: Bulkamid Transurethral Bulking Agent",[18,23],{"type":19,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Minimally invasive mesh device placed to treat stress urinary incontinence.",[9],null,{"type":19,"name":14,"description":24,"armGroupLabels":25,"otherNames":22},"Minimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed",[14],[27,31],{"name":28,"affiliation":29,"role":30},"Emily Lukacz, MD","University of California, San Diego","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"Marie Gantz, MD","RTI International",[35,56,76,93,110,127,144],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of California at San Diego","RECRUITING","La Jolla","California","92037-0974","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-117.2742,32.84727,{"lat":47,"lon":46},[50,55],{"name":51,"role":52,"phone":53,"phoneExt":22,"email":54},"Kyle Herrala","CONTACT","(858) 657-6827","UrogynRSCH@ucsd.edu",{"name":28,"role":30,"phone":22,"phoneExt":22,"email":22},{"facility":57,"status":37,"city":58,"state":39,"zip":59,"country":41,"countryCode":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Kaiser Permanente -- San Diego","San Diego","92110",{"type":44,"coordinates":61},[62,63],-117.16472,32.71571,{"lat":63,"lon":62},[66,70,74],{"name":67,"role":52,"phone":68,"phoneExt":22,"email":69},"Gisselle Zazueta-Damian","619-821-5717","gisselle.zazueta-damian@kp.org",{"name":71,"role":52,"phone":72,"phoneExt":22,"email":73},"Linda Mackinnon","619-821-6009","linda.m.mackinnon@kp.org",{"name":75,"role":30,"phone":22,"phoneExt":22,"email":22},"Shawn A Menefee, MD",{"facility":77,"status":37,"city":78,"state":79,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"University of Chicago","Chicago","Illinois","60637",{"type":44,"coordinates":82},[83,84],-87.65005,41.85003,{"lat":84,"lon":83},[87,91],{"name":88,"role":52,"phone":89,"phoneExt":22,"email":90},"Jinxuan (Rowena) Shi","872-724-0774","jinxuan.shi@bsd.uchicago.edu",{"name":92,"role":30,"phone":22,"phoneExt":22,"email":22},"Kimberly Kenton, MD",{"facility":94,"status":37,"city":95,"state":96,"zip":97,"country":41,"countryCode":42,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery","Durham","North Carolina","27707",{"type":44,"coordinates":99},[100,101],-78.89862,35.99403,{"lat":101,"lon":100},[104,108],{"name":105,"role":52,"phone":106,"phoneExt":22,"email":107},"Stephanie Yu","(919) 401-1016","stephanie.yu@duke.edu",{"name":109,"role":30,"phone":22,"phoneExt":22,"email":22},"Nazema Siddiqui, MD",{"facility":111,"status":37,"city":112,"state":113,"zip":114,"country":41,"countryCode":42,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":44,"coordinates":116},[117,118],-75.16362,39.95238,{"lat":118,"lon":117},[121,125],{"name":122,"role":52,"phone":123,"phoneExt":22,"email":124},"Zandra Kennedy","(215) 615-6569","zandra.kennedy@pennmedicine.upenn.edu",{"name":126,"role":30,"phone":22,"phoneExt":22,"email":22},"Heidi Harvie, MD",{"facility":128,"status":37,"city":129,"state":130,"zip":131,"country":41,"countryCode":42,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Brown\u002F Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery","Providence","Rhode Island","02903",{"type":44,"coordinates":133},[134,135],-71.41283,41.82399,{"lat":135,"lon":134},[138,142],{"name":139,"role":52,"phone":140,"phoneExt":22,"email":141},"Madeline Malloy","(401) 430-8228","MMMalloy@wihri.org",{"name":143,"role":30,"phone":22,"phoneExt":22,"email":22},"Vivian Sung, MD",{"facility":145,"status":37,"city":146,"state":147,"zip":148,"country":41,"countryCode":42,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":44,"coordinates":150},[151,152],-96.80667,32.78306,{"lat":152,"lon":151},[155,159],{"name":156,"role":52,"phone":157,"phoneExt":22,"email":158},"Agnes Burris","(214) 645-3833","Agnes.Burris@UTSouthwestern.edu",{"name":160,"role":30,"phone":22,"phoneExt":22,"email":22},"David Rahn, MD",{"type":162,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[164,167,169,170,171,172,174,175,176],{"name":165,"class":166},"Duke University","OTHER",{"name":168,"class":166},"Kaiser Permanente",{"name":77,"class":166},{"name":111,"class":166},{"name":145,"class":166},{"name":173,"class":166},"Women and Infants Hospital of Rhode Island",{"name":33,"class":166},{"name":29,"class":166},{"name":177,"class":178},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100552987","trial-of-transurethral-bulking-agent-injection-versus-single-incision-sling-for-stress-urinary-incontinence-100552987",false,"NCT06480227","Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence","A Randomized Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence","BASIS","Inclusion Criteria:\n\n* Women ≥ 21 years\n* For \\> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe\u002Fsignificant than UUI is required.\n* A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months.\n* Normal PVR \\\u003C 150 mL\n* Candidate for either study procedure as determined by treating surgeon\n* Available for up to 3 years.\n* Agrees to randomization.\n\nExclusion Criteria:\n\n* Anterior\u002Fapical vaginal prolapse beyond the hymen (\\>0 on POPQ)\n* Urge-predominant mixed UI despite stable therapy\n* Advanced UUI\u002FOAB 3rd line therapy treatment within 1 year of enrollment.\n* Planned hysterectomy, urethral or anterior\u002Fapical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months.\n* Malignancy or history of radiation of the pelvis\n* Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year\n* Incomplete emptying (PVR \\> 150mL)\n* Prior anti-incontinence procedure\n* Neurogenic bladder\n* Unwilling to continue current UUI treatment until completion of primary outcome at 12 months\n* Prior adverse reaction to synthetic mesh or urethral bulking material\n* Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.)\n* Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.","FEMALE","21 Years",{"count":190,"type":191},358,"ESTIMATED","INTERVENTIONAL",[194],"NA","This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care.\n\nThe Primary Aim is to determine the comparative effectiveness (as defined by \"much\" or \"very much\" better on PGI-I) of transurethral bulking agent (TBA) \\[for 1 or 2 injections in 12 months\\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).",[197,198,199],"Stress Urinary Incontinence","Urinary Incontinence","Mixed Urinary Incontinence",[198,201,202,203],"Pelvic Floor Disorders","Single Incision Sling","Transurethral Bulking Agent","2026-06-04",{"date":206,"type":207},"2026-06-08","ACTUAL",{"date":209,"type":207},"2024-08-28",{"date":211,"type":191},"2030-12-31",{"name":5,"class":6},7]