3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.

• Conditions: Pelvic Floor Disorders
• Interventions: Diagnostic Test: pelvic floor ultrasound

• Registration Number: NCT04561843
• Lead Sponsor: Assiut University

Brief Summary

The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

Detailed Description

The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods \[6\]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-20
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-24
• Last Update Submitted: 2020-09-24
• Last Update Posted: 2020-09-28
• Study Start: 2020-12-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 91

Inclusion Criteria

• Women complaining of any of the pelvic floor disorder symptoms.

Exclusion Criteria

• women with a history of chronic intestinal disease (Crohn's disease, ulcerative colitis), acute gastroenteritis within the week preceding consultation women who underwent any surgical or diagnostic procedure involving the anal canal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	pelvic floor ultrasound	Women not complaining of any of the pelvic floor disorder symptoms
case group	pelvic floor ultrasound	Women complaining of any of the pelvic floor disorder symptoms such as: Pelvic organ prolapse (POP), Stress urinary incontinence (SUI), urgency symptoms of obstructed defecation, fecal incontinence (FI), pelvic pain, and/or sexual problems.

Primary Outcome Measures

Name	Time	Method
pelvic floor muscle function.	15 miutes	The hiatal antro-posterior distance (LHap) between the inferior margin of the pubic symphysis and the pubo-rectalis sling was measured at rest, on maximum contraction, and at valsalva. The percentage difference decrease \[valuerest valuecontraction/ valuerest\] for contraction is calculated as a measurement of pelvic floor muscle function.