RecruitingNCT07763613

Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)

Development and Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI): A Prospective Observational Study


Sponsor

Trabzon Kanuni Education and Research Hospital

Enrollment

75 participants

Start Date

Aug 13, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Ureteroscopy / Retrograde Intrarenal Surgery for people with urolithiasis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUreteroscopy / 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.


Locations(1)

Trabzon Kanuni Education and Research Hospital

Trabzon, Trabzon, Turkey (Türkiye)

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NCT07763613


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