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Completed

NCT Number: NCT05707793

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

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

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Key information

Conditions

Age range

35 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Minia university Hospital

Minya, Minya Governorate, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. ِAssessment of diaphragmatic force

    Time frame: 3 months

    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.

  2. Assessment of transverse abdominis thickness

    Time frame: 3 months

    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. Assessment of lumbar multifidus thickness

    Time frame: 3 months

    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.

  4. Assessment of pelvic floor muscle force

    Time frame: 3 months

    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.

Secondary outcomes

  1. Vaginal Laxity Questionnaire

    Time frame: 3 months

    It is the only available tool for vaginal laxity assessment. Therefore, it will be used to exclude the diagnosis of vaginal laxity for women in group (A) and to confirm the diagnosis of vaginal laxity for women in group (B) through asking women to score vaginal laxity on a scale of 1 to 7, with 1 being very loose and 7 being very tight (Krychman et al., 2017).

  2. The Female Sexual Function Index (FSFI)

    Time frame: 3 months

    The Female Sexual Function Index (FSFI) is a brief, multidimensional self-report instrument that will be used to assess the key dimensions of sexual function for women in both groups. The scale consists of 19 items yields domain scores in the following six areas: sexual desire, arousal, lubrication, orgasm, satisfaction and pain (Zachariou et al., 2017).

  3. Short-Form 36 Health Survey (SF-36)

    Time frame: 3 months

    It will be used to assess the quality of life for women in both groups. The scale is intended to assess disease burden and to assess the patient's quality of life as an indication of the patient's health status. It consists of 36 questions that evaluate eight domains: physical functioning (the ability to care for oneself and perform daily tasks); role limitations caused by physical health problems (the impact of one's physical health on one's capacity to perform daily tasks); bodily pain (the level of pain experienced whilst performing daily tasks); general health perceptions (how one sees one's own health); vitality (the capacity to carry out daily tasks); and social functioning. Scores range from zero (most affected) to one hundred (not affected) (Ramage et al., 2017).

  4. Modified Oxford grading scale

    Time frame: 3 months

    The modified Oxford grading scale (with scores from 0 to 5) will be used to evaluate the pelvic floor muscle strength for women in both groups through measuring the vaginal digital palpation in a crock-lying position (Ferreira et al., 2011).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Deraya University
  • Minia University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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