Ultrasound and Pelvic Floor Muscle Training

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    80
  • sponsor
    University Hospital, Caen
Updated on 12 September 2021

Summary

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

Description

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).

Details
Condition Ultrasonic Shockwave, Ultrasound, ultrasonic diagnosis, Ultrasound, Magnetic Resonance Elastography, Stress incontinence, Contraction; Pelvic, Urethral Hypermobility, elastography, sonoelastography, stress urinary incontinence, Contraction; Pelvic, Contraction; Pelvic
Treatment perineal ultrasound
Clinical Study IdentifierNCT04361890
SponsorUniversity Hospital, Caen
Last Modified on12 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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