[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651653":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":30,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Trabzon Kanuni Education and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-stented Group",null,"Patients undergoing ureteroscopy or retrograde intrarenal surgery (RIRS) who have a ureteral stent in place before the index procedure.",[13],"Procedure: Ureteroscopy \u002F Retrograde Intrarenal Surgery",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-pre-stented Group","Patients undergoing ureteroscopy or retrograde intrarenal surgery (RIRS) without a ureteral stent in place before the index procedure.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Ureteroscopy \u002F Retrograde Intrarenal Surgery","Ureteroscopy or retrograde intrarenal surgery (RIRS) will be performed for the treatment of urolithiasis according to routine clinical practice. No additional procedural intervention will be assigned by the study protocol.",[15,9],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"ADEM DENİZ, MD","CONTACT","+904623330030","adeemdeniz@gmail.com",[31],{"facility":5,"status":32,"city":33,"state":33,"zip":34,"country":35,"countryCode":10,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Trabzon","61080","Turkey (Türkiye)",{"type":37,"coordinates":38},"Point",[39,40],39.72694,41.005,{"lat":40,"lon":39},[43,45,48],{"name":44,"role":27,"phone":28,"phoneExt":10,"email":29},"adem deniz, md",{"name":46,"role":27,"phone":28,"phoneExt":10,"email":47},"recep erin","erinrecep@gmail.com",{"name":49,"role":50,"phone":10,"phoneExt":10,"email":10},"osman akyüz, md","PRINCIPAL_INVESTIGATOR",{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100651653","clinical-evaluation-of-the-pelvic-floor-fatigue-index-pffi-100651653",false,"NCT07763613","Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)","Development and Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI): A Prospective Observational Study","PFFI","Inclusion Criteria:\n\nAdults aged 18-65 years. Diagnosis of urolithiasis requiring ureteroscopy (URS) or retrograde intrarenal surgery (RIRS).\n\nPlanned postoperative double-J ureteral stent placement. Patients belonging to either the Non-pre-stented Group or the Pre-stented Group according to the study protocol.\n\nAbility to read and understand the validated Turkish version of the Ureteral Stent Symptom Questionnaire (USSQ).\n\nAbility to independently complete the USSQ. Ability to perform an adequate voluntary pelvic floor muscle contraction. Provision of written informed consent.\n\nExclusion Criteria:\n\nClinically significant diabetic neuropathy. Neurological disorders affecting lower urinary tract function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).\n\nActive lower urinary tract dysfunction (e.g., overactive bladder, neurogenic bladder, interstitial cystitis).\n\nPrevious pelvic floor surgery. Known urinary incontinence. Urethral stricture. Chronic prostatitis. Recurrent urinary tract infection. Urinary tract malignancy. Advanced chronic kidney disease. Previous upper urinary tract reconstructive surgery. Pregnancy. Active urinary tract infection. Inability to perform an adequate voluntary pelvic floor muscle contraction. Inability to provide informed consent.","ALL","18 Years","65 Years",{"count":65,"type":66},75,"ESTIMATED","OBSERVATIONAL","Background:\n\nUreteral stent-related symptoms vary considerably among patients despite similar surgical procedures and stent characteristics. Although several mechanisms have been proposed, the reasons for this interindividual variability remain incompletely understood. Pelvic floor muscle endurance may represent one of the patient-related factors contributing to symptom severity.\n\nThe Pelvic Floor Fatigue Index (PFFI) is a novel ultrasound-based index developed to quantify pelvic floor muscle endurance by measuring the percentage decline in bladder base elevation during a sustained maximum voluntary pelvic floor contraction using suprapubic transverse B-mode ultrasonography.\n\nThis prospective observational study aims to clinically evaluate the PFFI by investigating the association between preoperative PFFI measurements and postoperative ureteral stent-related symptoms assessed using the Ureteral Stent Symptom Questionnaire (USSQ). In addition, the study will evaluate the test-retest reliability of the PFFI measurement method and explore its potential role as an objective functional assessment tool for pelvic floor muscle endurance.\n\nThe findings of this study are expected to provide the first clinical evaluation of the PFFI and establish the methodological basis for future validation studies and broader clinical applications.",[70],"Urolithiasis",[72,59,73,74,75,76,77,70,78,79],"Pelvic Floor Fatigue Index","Ureteral Stent","Ureteral Stent-Related Symptoms","Ureteral Stent Symptom Questionnaire","USSQ","Pelvic Floor Muscle Endurance","Ureteroscopy","Retrograde Intrarenal Surgery","2026-08-16",{"date":82,"type":83},"2026-08-18","ACTUAL",{"date":85,"type":83},"2026-08-13",{"date":87,"type":66},"2026-12-25",{"name":5,"class":6},1]