Clinical trial NCT05707793: Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study
Official title: Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Laxity
Keywords: ultrasound imaging
core muscles activity
multiparous women
vaginal laxity
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Deraya University
name: Minia University
First posted: 2023-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: referred by gynecologists from the outpatient clinic for gynecology, Minia university Hospital, Minia, Egypt.

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

Detailed description: Vaginal laxity is characterized by the loss of elasticity in the vaginal structure and vaginal looseness, which leads to symptoms including sexual dysfunction, dyspareunia, chronic pelvic pain, and urinary incontinence. It is a symptom of pelvic floor dysfunction. Its mechanisms are not well understood and it is usually worse in women with multiparity.

Since the pelvic floor muscles (PFMs) are one of the core muscles that play a critical role in lumbopelvic stability, their impairment may affect the lumbopelvic area and the activity of other core muscles, like the transverse abdominis, lumbar multifidus, and diaphragm. Therefore, this study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: ِAssessment of diaphragmatic force
timeFrame: 3 months
measure: Assessment of transverse abdominis thickness
timeFrame: 3 months
measure: Assessment of lumbar multifidus thickness
timeFrame: 3 months
measure: Assessment of pelvic floor muscle force
timeFrame: 3 months
Secondary outcomes:
measure: Vaginal Laxity Questionnaire
timeFrame: 3 months
measure: The Female Sexual Function Index (FSFI)
timeFrame: 3 months
measure: Short-Form 36 Health Survey (SF-36)
timeFrame: 3 months
measure: Modified Oxford grading scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university Hospital
state: Minia
Study officials:
affiliation: Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
name: Doaa Osman, Assis. Prof.
role: PRINCIPAL_INVESTIGATOR
References: