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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04561843
• Other study ID #: AUG2020
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: Sief Ali, MD
• Phone: +201004971596
• Email: SiefAli73[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 91
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Floor Disorders

Intervention

Diagnostic Test:
• pelvic floor ultrasound
2D and 3D trans-perineum ultrasound examinations will be performed by single examiner who was blind to clinical data, using a GE Voluson 730 machine (GE Medical System Kretz Technik, Zipf, Austria) with a RAB 4-8 MHz curved array volume transducer. In the supine position, with flexed and slightly abducted hips after urine voiding. The transducer was placed on the perineum, in the mid sagittal plane with minimal pressure being applied after covering it with an un-powdered glove or thin plastic wrap for hygienic reasons

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pelvic floor muscle function.	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.	15 miutes