[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574035":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":38,"locations":44,"responsibleParty":60,"collaborators":63,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":25,"enrollmentInfo":95,"targetDuration":25,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Retropubic Midurethral Sling (RP-MUS)","ACTIVE_COMPARATOR","A minimally invasive surgical procedure that treats stress urinary incontinence (SUI) in women by placing a small strip of tape passed through the retropubic space, with entry and exit points in the lower abdomen or groin.",[13],"Device: RP-MUS",{"label":15,"type":10,"description":16,"interventionNames":17},"Urethral Bulking with polyacrylamide hydrogel (PAHG)","PAHG will be performed using the standard 2 mL dose injection order and number will be at the discretion of the surgeon. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites.",[18],"Procedure: PAHG",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","RP-MUS","a standard urethral sling placement for treatment of stress urinary incontinence",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","PAHG","A standard 2 mL dose injection of bulkamid (order and number will be at the discretion of the surgeon) will be given. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"David Sheyn, MD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Cecile Ferrando, MD","University of California, San Diego",[39],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},"Elisar Khawam","CONTACT","216-844-2493","Elisar.Khawam@UHhospitals.org",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-81.69541,41.4995,{"lat":56,"lon":55},[59],{"name":40,"role":41,"phone":42,"phoneExt":25,"email":43},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"David Sheyn","Associate professor",[64,66,68,70,71,73,75,77,79,81,83],{"name":65,"class":6},"Kaiser Permanente",{"name":67,"class":6},"Duke University",{"name":69,"class":6},"Patient-Centered Outcomes Research Institute",{"name":37,"class":6},{"name":72,"class":6},"University of California, Irvine",{"name":74,"class":6},"MetroHealth Medical Center",{"name":76,"class":6},"Ohio State University",{"name":78,"class":6},"Northwestern University",{"name":80,"class":6},"University of New Mexico",{"name":82,"class":6},"Medstar Health Research Institute",{"name":84,"class":6},"University of Michigan","100574035","believe-trial-bulking-versus-sling-for-treating-stress-urinary-incontinence-at-the-time-of-vaginal-prolapse-repair-believe-100574035",false,"NCT06754046","BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)","BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair","BELIEVE","Inclusion Criteria:\n\n* Women ≥ 18 years of age.\n* Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).\n* Proof of positive testing for SUI via cough stress test (CST) and\u002For Urodynamic (UDS) testing,\n* Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)\n\nExclusion Criteria:\n\n* Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue\n* Patient anticipating difficulty with completing 24-month follow-up\n* Anticipation of pregnancy within subsequent 24-months or \\\u003C18 months post-partum\n* Hemoglobin A1c \\>10.0% within the past 3-months\n* Current smoker \\> 1 pack per week\n* History of neurogenic bladder\n* Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter\n* Post-void residual \\>150 mL felt to not be due to obstruction for prolapse\n* Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking\n* Previous history of any pelvic radiation\n* Patient receiving a planned concurrent procedure at the time of prolapse repair.","FEMALE","18 Years",{"count":96,"type":97},476,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are:\n\nWhat is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile?\n\nParticipants will:\n\nBe blinded and randomized to one of two procedures for the duration of the study, 24 months.\n\nComplete 6 total visits for the clinical trial including validated questionnaires.\n\nFew participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.",[103,104],"Stress Urinary Incontinence","Vaginal Prolapse",[106,107,108,109,110],"midurethral sling","bulkamide","polyacrylamide hydrogel","urethral bulking","retropubic sling","2026-05-27",{"date":113,"type":114},"2026-06-01","ACTUAL",{"date":116,"type":114},"2025-05-01",{"date":118,"type":97},"2029-04",{"name":5,"class":6},1]