Ultrasound and Pelvic Floor Muscle Training

NCT ID: NCT04361890

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-07
• Study Completion Date: 2022-02-28

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Women with predominant SUI

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

Group Type: OTHER

perineal ultrasound

Intervention Type: DIAGNOSTIC_TEST

all women will have ultrasound measurements of the bladder neck descent, of the movement of the ano-rectal angle during a Valsalva maneuver and elastographic measurement before and after PFMT. All measurement will be conducted by perineal route, with is a non invasive ultrasound route

Interventions

perineal ultrasound

all women will have ultrasound measurements of the bladder neck descent, of the movement of the ano-rectal angle during a Valsalva maneuver and elastographic measurement before and after PFMT. All measurement will be conducted by perineal route, with is a non invasive ultrasound route

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clemence Tomadesso, PhD

Role: STUDY_CHAIR

University Hospital of Caen

Locations

Pizzoferato

Caen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne Cecile Pizzoferrato, MD

Role: CONTACT

acpizzofe@gmail.com

+33682176675

Estelle Jamard, MD

Role: CONTACT

jamard-e@chu-caen.fr

+33688323211

Facility Contacts

Anne Cecile Pizzoferrato, MD

Role: primary

pizzoferrato-ac@chu-caen.fr

+33231272336

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Other Identifiers

2019-A01425-52

Identifier Type: -

Identifier Source: org_study_id