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

NCT ID: NCT04561843

Last Updated: 2020-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 91 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-06-01

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.

Conditions

Pelvic Floor Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

case group

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.

pelvic floor ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

control group

Women not complaining of any of the pelvic floor disorder symptoms

pelvic floor ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sief el eslam Ahmed Ali

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sief Ali, MD

Role: CONTACT

SiefAli73@yahoo.com

+201004971596

Abdalla Mohammed Sayed, master

Role: CONTACT

Abdallahmsm43@gmail.com

Other Identifiers

AUG2020

Identifier Type: -

Identifier Source: org_study_id