[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615246":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":43,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Harran University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PLP Arm","EXPERIMENTAL","Patients undergoing mesh-free Pubo-Urethral Ligament Plication (PLP), a native tissue surgical technique performed to reinforce urethral support without the use of synthetic mesh.",[13],"Procedure: Pubo-Urethral Ligament Plication (PLP)",{"label":15,"type":16,"description":17,"interventionNames":18},"TOT Arm","ACTIVE_COMPARATOR","Patients undergoing the Transobturator Tape (TOT) procedure, a widely used mesh-based midurethral sling technique performed to provide urethral support via the transobturator route.",[19],"Procedure: Transobturator Tape (TOT)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Pubo-Urethral Ligament Plication (PLP)","A mesh-free native tissue surgical technique that reinforces urethral support by plicating the pubo-urethral ligament. The procedure aims to restore midurethral stability without the use of synthetic mesh.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Transobturator Tape (TOT)","A mesh-based midurethral sling procedure performed through the transobturator route to provide urethral support. The tape is positioned under the midurethra to treat stress urinary incontinence.",[15],[32],{"name":33,"affiliation":5,"role":34},"MEHMET İNCEBIYIK, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Mehmet İNCEBIYIK, MD","CONTACT","+905353374889","drmehmetincebiyik@gmail.com",{"name":42,"role":38,"phone":26,"phoneExt":26,"email":40},"Ömer TAMMO, MD",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":26,"cosmosGeoPoint":26,"geoPoint":26,"contacts":51},"Harran University Research and Application Hospital","RECRUITING","Şanliurfa","HALİLİYE","63300","Turkey (Türkiye)",[52,54,55],{"name":33,"role":38,"phone":53,"phoneExt":26,"email":40},"+9005353374889",{"name":26,"role":38,"phone":26,"phoneExt":26,"email":40},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Mehmet Incebıyik","Assistant Professor of Obstetrics and Gynecology","100615246","mesh-free-versus-mesh-based-surgery-for-female-stress-urinary-incontinence-a-prospective-comparison-of-pubo-urethral-ligament-plication-and-transobturator-tape-100615246",false,"NCT07290114","Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape","Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape With Short-Term Patient-Centered Outcomes","PLP-TOT","Inclusion Criteria:\n\nFemale patients aged 18-80 years\n\nClinical diagnosis of stress urinary incontinence\n\nFailure of conservative management (pelvic floor exercises or medical therapy)\n\nDesire to undergo surgical treatment (PLP or TOT)\n\nAbility to provide informed consent\n\nWillingness to attend postoperative follow-up visits\n\nExclusion Criteria:\n\n* Mixed urinary incontinence with predominant urge symptoms\n\nActive urinary tract infection\n\nPelvic organ prolapse ≥ stage II\n\nPrevious anti-incontinence surgery\n\nNeurological diseases affecting bladder function\n\nPregnancy or planning pregnancy during follow-up\n\nUncontrolled diabetes, bleeding disorders, or contraindications to surgery\n\nUse of medications affecting bladder function (e.g., anticholinergics)\n\nInability to provide informed consent","FEMALE","18 Years","80 Years",{"count":72,"type":73},147,"ESTIMATED","INTERVENTIONAL",[76],"NA","This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.",[79],"Stress Urinary Incontinence (SUI)",[81],"Stress Urinary Incontinence, Pubo-Urethral Ligament Plication, PLP, Transobturator Tape, TOT, Mesh-free surgery, Midurethral sling","2025-12-04",{"date":84,"type":85},"2025-12-18","ACTUAL",{"date":87,"type":85},"2025-01-13",{"date":89,"type":73},"2026-09",{"name":58,"class":6},1]