Ultrasound Clinical Trial
— ERPOfficial title:
Validity of Ultrasound in Women Having Pelvic Floor Muscle Training
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
Status | Recruiting |
Enrollment | 80 |
Est. completion date | February 2022 |
Est. primary completion date | February 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Pizzoferato | Caen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
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* Note: There are 34 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bladder neck descent reliability before PFMT | 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 | 2 years | |
Primary | ano-rectal angle mobility reliability before PFMT | 2 measurements of the ano-rectal angle mobility during a Valsalva maneuver will be conducted by two operators using perineal ultrasound | 2 years | |
Primary | perineal elastography reliability before PFMT | 2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound | 2 years | |
Primary | bladder neck descent change after PFMT | 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 | 2 years | |
Primary | ano-rectal angle mobility change after PFMT | comparison of the ano-rectal angle mobility during a Valsalva maneuver will be conducted before and after PFMT using perineal ultrasound | 2 years | |
Primary | perineal elastogaphy change after PFMT | comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound | 2 years | |
Secondary | correlation analyses between bladder neck descent measurements and urinary symptoms | 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) | 2 years | |
Secondary | patients satisfaction after pelvic floor muscle training | the satisfaction will be assessed using the validated questionnaire "Patient Global Impression of Improvement" (PGI-I) after PFMT | 2 years |
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