Health TrialsbyHealthPanel

Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)

ConditionUrolithiasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTrabzon Kanuni Education and Research Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult patients with urolithiasis scheduled to undergo ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with postoperative double-J ureteral stent placement at the study center. Eligible participants will undergo standardized transabdominal ultrasonographic assessment of pelvic floor fatigability before surgery and will complete postoperative ureteral stent symptom assessment according to the study protocol.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ureteroscopy / Retrograde Intrarenal Surgery

    Procedure/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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: Pre-stented Group1 intervention
Group B: Non-pre-stented Group1 intervention

Trial outcomes

Primary outcomes

1

Association Between Preoperative PFFI and Postoperative Total USSQ Score

The association between the preoperative Pelvic Floor Fatigue Index (PFFI) and postoperative ureteral stent-related symptom burden will be assessed using the total Ureteral Stent Symptom Questionnaire (USSQ) score obtained on postoperative Day 10. Higher PFFI values indicate greater pelvic floor fatigability, and higher total USSQ scores indicate greater stent-related symptom burden.

Time frame
Preoperative assessment to postoperative Day 10

Secondary outcomes

1

Association Between Preoperative Dmax and Postoperative Total USSQ Score

The association between preoperative Dmax, defined as the maximum bladder base elevation measured during a maximum voluntary pelvic floor contraction using suprapubic transverse B-mode ultrasonography, and postoperative ureteral stent-related symptom burden will be assessed using the total Ureteral Stent Symptom Questionnaire (USSQ) score obtained on postoperative Day 10.

Time frame
Preoperative assessment to postoperative Day 10
2

Test-Retest Reliability of PFFI Measurement

The intra-rater test-retest reliability of PFFI measurement will be evaluated in the first 12 participants. PFFI measurements will be repeated by the same investigator under standardized conditions following a rest period of approximately 10-15 minutes. Reliability will be assessed using the Intraclass Correlation Coefficient (ICC), and agreement between repeated measurements will additionally be evaluated using Bland-Altman analysis.

Time frame
During the same preoperative assessment session, with approximately 10-15 minutes between measurements
3

Change in PFFI From Preoperative Assessment to Postoperative Day 10

Pelvic floor fatigability will be assessed using the Pelvic Floor Fatigue Index (PFFI) before surgery and again on postoperative Day 10 while the ureteral stent is in situ. The change in PFFI between the two assessments will be evaluated to determine whether ureteral stenting is associated with a change in pelvic floor fatigability.

Time frame
Preoperative assessment and postoperative Day 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Trabzon Kanuni Education and Research Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now