Clinical Trial

Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)

Study acronym: PFFI
Not Yet Recruiting
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Summary
Background: Ureteral 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. The 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. This 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. The 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.
Trial Details
NCT Number NCT07763613
Lead Sponsor Trabzon Kanuni Education and Research Hospital
Conditions Urolithiasis
Enrollment 75 participants
Start Date 2026-08-10
Primary Completion 2026-12-25 (estimated)
Study Completion 2026-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-13