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Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)

NCT07763613 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Urolithiasis

Interventions

PROCEDURE

Ureteroscopy / 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.

Sponsors & Collaborators

  • Trabzon Kanuni Education and Research Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2026-12-25
Completion
2026-12-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07763613 on ClinicalTrials.gov