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临床试验/NCT04361890
NCT04361890Unknown不适用

Validity of Ultrasound in Women Having Pelvic Floor Muscle Training

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月7日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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