Minia university Hospital
Minya, Minya Governorate, Egypt
NCT Number: NCT05707793
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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Notify Me35 year–45 year
Female
Observational
Minya, Minya Governorate, Egypt
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation through Vaginal Laxity Questionnaire, Female Sexual Function Index, Short-Form 36 Health Survey, modified Oxford grading scale and ultrasound imaging
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.
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.
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.
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.
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).
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).
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).
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).
Cairo University
Other
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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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