Ultrasound and Pelvic Floor Muscle Training (ERP)

Caen University Hospital

Status: Unknown

Conditions: Urethral Hypermobility; Contraction; Pelvic; Elastography; Urinary Incontinence,Stress; Ultrasound

Treatments: Diagnostic Test: perineal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04361890

2019-A01425-52

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Women with predominant SUI

Other group

Description:

All women with predominant SUI will be referred to a physiotherapist for PFMT as usually. They will have an ultrasound evaluation before and after the session

Treatment:

Diagnostic Test: perineal ultrasound