Clinical trial NCT04361890: Ultrasound and Pelvic Floor Muscle Training
Official title: Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence,Stress
Ultrasound
Elastography
Contraction; Pelvic
Urethral Hypermobility
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: ultrasonographic measurements before and after pelvic floor muscle training
Primary purpose: DIAGNOSTIC

Brief 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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Bladder neck descent reliability before PFMT
timeFrame: 2 years
measure: ano-rectal angle mobility reliability before PFMT
timeFrame: 2 years
measure: perineal elastography reliability before PFMT
timeFrame: 2 years
measure: bladder neck descent change after PFMT
timeFrame: 2 years
measure: ano-rectal angle mobility change after PFMT
timeFrame: 2 years
measure: perineal elastogaphy change after PFMT
timeFrame: 2 years
Secondary outcomes:
measure: correlation analyses between bladder neck descent measurements and urinary symptoms
timeFrame: 2 years
measure: patients satisfaction after pelvic floor muscle training
timeFrame: 2 years
Other outcomes:
Locations:
city: Caen
country: France
facility: Pizzoferato
Study officials:
affiliation: University Hospital of Caen
name: Clemence Tomadesso, PhD
role: STUDY_CHAIR
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