[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562703":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Izmir Bakircay University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intraurethral injection group","EXPERIMENTAL","Intraurethral Cross-linked hyaluronic acid\u002Fdextranomer injection was performed in female patients with Stress Urinary incontinence",[13],"Procedure: Intraurethral injection",{"label":15,"type":16,"description":17,"interventionNames":18},"Mid-urethral sling group","ACTIVE_COMPARATOR","Mid-urethral sling procedure was performed in female patients with Stress Urinary incontinence",[19],"Procedure: Mid-urethral sling",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Intraurethral injection","Procedure: Intraurethral injection\n\nPatients are positioned in the lithotomy position during the procedure. General and\u002For local anesthesia is administered depending on the investigator\\'s preference. An applicator developed for intraurethral injection will be used. This device comprises a holder that is placed into and fixates the urethra (i.e., it distends the urethral circumference, thus smoothing out the longitudinal folds), allowing the use of four syringes to inject cross-linked hyaluronic acid\u002Fdextranomer at approximately the 2, 4, 8, and 10 o'clock positions.\n\nDrug: Cross-linked hyaluronic acid\u002Fdextranomer",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mid-urethral sling","Procedure: Starting with the dorsal lithotomy position, a foley catheter is inserted to the urethra. Starting with 1-1.5 cm below the urethral meatus, a 1.5-2 cm vertical incision is made. Following the dissection of anterior vaginal mucosa, pubocervical fascia should be dissected sharply .\n\nDissection is continued laterally to the ischiopubic ramus. Starting downwards from the tendinous insertion of the adductor longus muscle at the level of clitoris, a 1cm incision is made close to the bone. The needle is placed in to the incision and passed medially through the obturator membrane. It has to be considered that the needle is passed very close to the bone in order not to damage the obturator vessel-nerve bundle. With the guidance of the opposite hand's index finger in the vaginal incision the tip of the needle has to be palpated afterwards passing with a 45-degree angle rotation. The next manoeuvre is passing the tip of the needle beside the urethra through the vaginal incision .",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"İBRAHİM KARACA Associate Prof.","CONTACT","+905072864474","ibrahim.karaca@bakircay.edu.tr",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":26,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"İzmir Bakircay University","Izmir","BAYRAKLI","35050","Turkey (Türkiye)",{"type":45,"coordinates":46},"Point",[47,48],27.13838,38.41273,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":35,"phoneExt":26,"email":36},"İBRAHİM KARACA, ASSOCIATE PROF.",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","İBRAHİM KARACA","Associate Proffesor","100562703","phase-2-cross-linked-hyaluronic-aciddextranomer-for-the-treatment-of-stress-urinary-incontinence-100562703",false,"NCT06606613","Cross-linked Hyaluronic Acid\u002Fdextranomer for the Treatment of Stress Urinary Incontinence","Midurethral Sling Versus Cross-linked Hyaluronic Acid\u002Fdextranomer (CLHA\u002FDx) for the Treatment of Stress Urinary Incontinence","(CLHA\u002FDx)","Inclusion Criteria:\n\n* Diagnosis of Stress Urinary Incontinence.\n* Presence of incontinence during the Valsalva maneuver.\n* Positive Marshall-Marchetti test result.\n* Post-void residual urine volume of ≤100 mL.\n\nExclusion Criteria:\n\n* Temporary urinary incontinence.\n* Delirium.\n* Urinary tract infection.\n* Urethritis.\n* Pure urge incontinence.\n* Nocturnal enuresis.\n* Decreased bladder compliance or detrusor contraction observed in urodynamic -studies.\n* Leakage of urine with low bladder pressure.\n* Psychiatric conditions (severe depression and anxiety).\n* Body mass index (BMI) \\> 35 kg\u002Fm².\n* Use of medications that may influence bladder storage or emptying.","FEMALE","18 Years","75 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The investigators aimed to evaluate the effectiveness and safety of intraurethral cross-linked hyaluronic acid\u002Fdextranomer (CLHA\u002FDx) injection for the treatment of stress urinary incontinence (SUI) in women.",[76],"Urinary Stress Incontinence (SI)",[78,28,79,80],"Cross-linked hyaluronic acid\u002Fdextranomer","Female","Stress Urinary Incontinence","NOT_YET_RECRUITING","2024-09-24",{"date":84,"type":85},"2024-09-26","ACTUAL",{"date":87,"type":70},"2024-10-10",{"date":89,"type":70},"2025-04-10",{"name":5,"class":6},1]