Development and Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI): A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Association Between Preoperative PFFI and Postoperative Total USSQ Score
研究概览
简要总结
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.
详细描述
Background
Ureteral stent-related symptoms are common following ureteroscopy (URS) and retrograde intrarenal surgery (RIRS). Despite similar surgical procedures, stent characteristics, and postoperative management, symptom severity varies considerably among patients. Although trigonal irritation, local inflammation, vesicoureteral reflux, and the mechanical effects of the distal stent have been proposed as contributing mechanisms, these factors do not fully explain the observed interindividual variability.
Pelvic floor muscle function may represent an additional patient-related factor influencing symptom severity. While current assessment methods primarily evaluate maximal voluntary contraction or anatomical movement, no standardized ultrasound-based method is currently available to objectively quantify pelvic floor muscle endurance.
Study Rationale
The Pelvic Floor Fatigue Index (PFFI) was developed to provide an objective, non-invasive, and reproducible ultrasound-based assessment of pelvic floor muscle endurance. The index quantifies the percentage decline in bladder base elevation during a sustained maximum voluntary pelvic floor contraction using suprapubic transverse B-mode ultrasonography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years. Diagnosis of urolithiasis requiring ureteroscopy (URS) or retrograde intrarenal surgery (RIRS).
- •Planned 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.
- •Ability to read and understand the validated Turkish version of the Ureteral Stent Symptom Questionnaire (USSQ).
- •Ability to independently complete the USSQ. Ability to perform an adequate voluntary pelvic floor muscle contraction. Provision of written informed consent.
排除标准
- •Clinically significant diabetic neuropathy. Neurological disorders affecting lower urinary tract function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
- •Active lower urinary tract dysfunction (e.g., overactive bladder, neurogenic bladder, interstitial cystitis).
- •Previous 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.
研究组 & 干预措施
Non-pre-stented Group
Patients undergoing ureteroscopy or retrograde intrarenal surgery (RIRS) without a ureteral stent in place before the index procedure.
干预措施: Ureteroscopy / Retrograde Intrarenal Surgery (Procedure)
Pre-stented Group
Patients undergoing ureteroscopy or retrograde intrarenal surgery (RIRS) who have a ureteral stent in place before the index procedure.
干预措施: Ureteroscopy / Retrograde Intrarenal Surgery (Procedure)
结局指标
主要结局
Association Between Preoperative PFFI and Postoperative Total USSQ Score
时间窗: Preoperative assessment to postoperative Day 10
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.
次要结局
- Association Between Preoperative Dmax and Postoperative Total USSQ Score(Preoperative assessment to postoperative Day 10)
- Test-Retest Reliability of PFFI Measurement(During the same preoperative assessment session, with approximately 10-15 minutes between measurements)
- Change in PFFI From Preoperative Assessment to Postoperative Day 10(Preoperative assessment and postoperative Day 10)