Ultrasound and Pelvic Floor Muscle Training

NCT04361890 | Unknown

• 1 other identifier: 2019-A01425-52
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• perineal elastography reliability before PFMT

  2 measurements of perineal elastography (periurethral measurements) will be conducted by two operators using perineal ultrasound

  2 years

• 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

• 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

• perineal elastogaphy change after PFMT

  comparison of perineal elastography (periurethral measurements) will be conducted before and after PFMT using perineal ultrasound

  2 years

Secondary Outcomes (2)

• correlation analyses between bladder neck descent measurements and urinary symptoms

  2 years

• patients satisfaction after pelvic floor muscle training

  2 years

Study Arms (1)

Women with predominant SUI

OTHER

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

Diagnostic Test: perineal ultrasound

Interventions

perineal ultrasound 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

Women with predominant SUI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Pizzoferato

Caen, 14000, France

RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemence Tomadesso, PhD

  University Hospital of Caen

  STUDY CHAIR

Central Study Contacts

Anne Cecile Pizzoferrato, MD

CONTACT

+33682176675; acpizzofe@gmail.com

Estelle Jamard, MD

CONTACT

+33688323211; jamard-e@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: ultrasonographic measurements before and after pelvic floor muscle training

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: January 7, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)