Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Bladder neck descent reliability before PFMT
研究概览
简要总结
The objective is to validate the use of ultrasound measurements (urethral mobility, movement of the ano-rectal angle, elastography measurements) in women with urinary incontiennce before and after pelvic floor muscle training (PFMT) : inter and intra-observer reproducibility; correlation with clinical examination (modified Oxford scale); sensitivity to change before/after pelvic floor muscle training
详细描述
Introduction
Stress urinary incontinence (SUI) is defined by involuntary loss of urine. According to the literature, its prevalence ranges from 30 to 60%. The first-line treatment of SUI is pelvic floor muscle training (PFMT). The assessment of pelvic floor muscle (PFM) contraction is essentially clinical, based on the modified OXFORD system associated with symptom questionnaires. Ultrasound is more widely used in case of SUI but has never been evaluated before and after PFMT.
Objective
The main objective of this study will be to carry out a validation study of ultrasound measurements in women with predominant SUI (urethral mobility, movement of the ano-rectal angle, elastography): Inter/intra-observer reproducibility; variability versus measurement by correlation with clinical examination (modified Oxford scale); sensitivity to change before/after PFMT Secondary objectives will be to show a correlation between the different ultrasound measurements and the clinical symptoms assessed by validated questionnaires : International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Contilife. A quantitative pulseal elastography analysis by Ultra-fast shear wave elastography (Supersonic Imagine) will also be performed before and after PFMT, looking for changes after PFMT. We Patient satisfaction after PFMT will also be assessed using the validated "Patient Global Impression of Improvement" questionnaire (PGI-I) Materials and Methods: This is a single-center prospective study involving patients in PFMT for predominant SUI. Patients will have a 10-week PFMT protocol. An evaluation will be conducted at the beginning and end of the program. This will include an assessment of symptoms using validated questionnaires (ICIQ-SF, CONTILIFE), a clinical examination (modified Oxford scale), as well as transperineal ultrasound measurements of urethral mobility (Bladder Neck Desent, BND measured in centimeters), movement of ano-rectal angle and quantitative elastography measurements (Ultra-fast shear wave, elasticity E expressed in kiloP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18 years old
- •referred for predominant SUI
- •agreeing to participate in the study
- •beneficiary of a social security scheme or entitled
- •having been informed about the study (non-opposition)
排除标准
- •Minor patients, under guardianship, under curator
- •Patients who do not understand French
- •Pregnant women
- •Women with stage 2 or more prolapse according to the POP-Q classification
- •Women with a history of:
- •pelvis / spine trauma
- •perineal pain
- •urinary or vaginal infection
- •perineal surgery for urinary incontinence and/or prolapse
- •spinal surgery
- •pacemaker
- •respiratory pathology
- •neurological disorders
结局指标
主要结局
Bladder neck descent reliability before PFMT
时间窗: 2 years
2 measurements of the bladder neck descent during a Valsalva maneuver (as described by Dietz et al.) will be conducted by two operators using perineal ultrasound
ano-rectal angle mobility reliability before PFMT
时间窗: 2 years
2 measurements of the ano-rectal angle mobility during a Valsalva maneuver will be conducted by two operators using perineal ultrasound
ano-rectal angle mobility change after PFMT
时间窗: 2 years
comparison of the ano-rectal angle mobility during a Valsalva maneuver will be conducted before and after PFMT using perineal ultrasound
perineal elastogaphy change after PFMT
时间窗: 2 years
comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound
perineal elastography reliability before PFMT
时间窗: 2 years
2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
bladder neck descent change after PFMT
时间窗: 2 years
comparison of the bladder neck descent during a Valsalva maneuver (as described by Dietz et al.) will be conducted before and after PFMT using perineal ultrasound
次要结局
- correlation analyses between bladder neck descent measurements and urinary symptoms(2 years)
- patients satisfaction after pelvic floor muscle training(2 years)
