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

NCT ID: NCT05707793

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Vaginal Laxity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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women suffering from vaginal laxity

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

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

Intervention Type 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

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

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

Intervention Type OTHER

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

Interventions

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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

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Deraya University

OTHER

Sponsor Role collaborator

Minia University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Doaa A. Osman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa Osman, Assis. Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Minia university Hospital

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/012/004230

Identifier Type: -

Identifier Source: org_study_id

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