Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study

NCT05707793 | Completed

• 1 other identifier: P.T.REC/012/004230
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

Conditions

Vaginal Laxity

Keywords

ultrasound imaging; core muscles activity; multiparous women; vaginal laxity

Outcome Measures

Primary Outcomes (4)

• ِAssessment of diaphragmatic force

  Diaphragmatic excursion will be measured, using an ultrasound device, by placing calipers at the bottom and top of the diaphragmatic inspiratory slope. All measurements will be taken at the end of expiration phase for women in both groups.

  3 months

• Assessment of transverse abdominis thickness

  The measurement of transverse abdominis muscle will be taken from the lower border of internal obliques muscle to the inferior hyperechoic line of peritoneum at rest and during the abdominal drawing in maneuvers (ADIM) for women in both groups, using an ultrasound device.

  3 months

• Assessment of lumbar multifidus thickness

  Lumbar multifidus will be measured, using an ultrasound device, along the line from the L4-5 zygapophyseal joint to the superior border of the lumbar multifidus for women in both groups.

  3 months

• Assessment of pelvic floor muscle force

  It will be assessed, using an ultrasound device, for women in both groups. The position of the bladder base at rest will be marked electronically with an 'X'. The subject will then perform a maximum voluntary pelvic floor muscle contraction and the image will be captured at the moment of maximum displacement. At this time, the subject will relax the pelvic floor muscles. The investigator will then measure the displacement to its current position in the stilled image and will be blinded to the measurement value until after the caliper has been fixed at the end point.

  3 months

Secondary Outcomes (4)

• Vaginal Laxity Questionnaire

  3 months

• The Female Sexual Function Index (FSFI)

  3 months

• Short-Form 36 Health Survey (SF-36)

  3 months

• Modified Oxford grading scale

  3 months

Study Arms (2)

women suffering from vaginal laxity

self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire

Other: Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles

normal subjects without vaginal laxity

No self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire

Other: Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles

Interventions

Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core muscles OTHER

Evaluation through Vaginal Laxity Questionnaire, Female Sexual Function Index, Short-Form 36 Health Survey, modified Oxford grading scale and ultrasound imaging

normal subjects without vaginal laxity; women suffering from vaginal laxity

Eligibility Criteria

• Age: 35 Years - 45 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

referred by gynecologists from the outpatient clinic for gynecology, Minia university Hospital, Minia, Egypt.

You may qualify if:

• The participants' age range from 35 to 45 years
• their body mass index is 25-30 kg/m2,
• The number of normal deliveries ≤ three times,
• having a regular menstruation.
• They participate in the study after at least two years from their last delivery.

You may not qualify if:

• Prior history of disc prolapse and sacroiliac joints, symphysis pubic joint as well as lower limb problems, leg length discrepancy, and diastasis recti.
• Surgery related to the spine, abdomen or pelvis.
• Genital prolapse, urinary tract infection, and intrauterine device.
• Diabetes, chest and/or cardiac disease.
• Using any drugs for sexual dysfunction.

Sponsors & Collaborators

• Cairo University: lead
• Deraya University: collaborator
• Minia University: collaborator

Study Sites (1)

Minia university Hospital

Minya, Minya Governorate, Egypt

Location

MeSH Terms

Interventions

Quality of Life

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Doaa Osman, Assis. Prof.

  Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 1, 2023
• Study Start: November 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

EG (1)