Ultrasound and Pelvic Floor Muscle Training

Not Applicable

• Conditions: Elastography; Ultrasound; Contraction; Pelvic; Urinary Incontinence,Stress; Urethral Hypermobility
• Interventions: Diagnostic Test: perineal ultrasound

• Registration Number: NCT04361890
• Lead Sponsor: University Hospital, Caen

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).

Study Timeline

• Study Start: 2020-01-07
• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women with predominant SUI	perineal ultrasound	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

Primary Outcome Measures

Name	Time	Method
Bladder neck descent reliability before PFMT	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	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	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	2 years	comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound
perineal elastography reliability before PFMT	2 years	2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound
bladder neck descent change after PFMT	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

Secondary Outcome Measures

Name	Time	Method
correlation analyses between bladder neck descent measurements and urinary symptoms	2 years	the bladder neck descent measurements will be compared before and after PFMT to the urinary symptoms using the validated questionnaire ICIQ-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form)
patients satisfaction after pelvic floor muscle training	2 years	the satisfaction will be assessed using the validated questionnaire "Patient Global Impression of Improvement" (PGI-I) after PFMT

Trial Locations

Locations (1)

Pizzoferato; 🇫🇷 Caen, France