Vaginal LaxityNCT05707793
Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study
An observational study of Vaginal Laxity, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Vaginal Laxity
- What is being tested?
- 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
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- Adult
Study population: referred by gynecologists from the outpatient clinic for gynecology, Minia university Hospital, Minia, Egypt.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the ultrasound imaging of core muscles activity in multiparous women with vaginal laxity versus normal controls.
Read the 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.
- Conditions
- Vaginal Laxity
- Being tested
- 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
- Keywords
- ultrasound imaging, core muscles activity, multiparous women, vaginal laxity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core musclesOther
Evaluation through Vaginal Laxity Questionnaire, Female Sexual Function Index, Short-Form 36 Health Survey, modified Oxford grading scale and ultrasound imaging
| Study group | Role | What they receive |
|---|---|---|
| women suffering from vaginal laxity | self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ِ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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
Vaginal Laxity Questionnaire
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).
Measured: 3 months
The Female Sexual Function Index (FSFI)
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).
Measured: 3 months
Short-Form 36 Health Survey (SF-36)
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).
Measured: 3 months
Modified Oxford grading scale
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start15 Nov 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal LaxityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Deraya University, Minia University
- Responsible party
- Principal investigator, Doaa A. Osman, Cairo University
- Investigators
- Doaa Osman, Assis. Prof., Principal investigator, Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707793
- Sponsor's protocol ID
- P.T.REC/012/004230
- Status last verified
- Apr 2023
- First submitted
- 18 Jan 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Core Muscles Activity in Multiparous Women With Vaginal Laxity: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05707793
- Acronym / sponsor ID
- P.T.REC/012/004230
- Conditions
- Vaginal Laxity
- Keywords
- ultrasound imaging, core muscles activity, multiparous women, vaginal laxity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Deraya University, Minia University
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women suffering from vaginal laxity | – | 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 musclesself-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire |
| normal subjects without vaginal laxity | – | 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 musclesNo self-reported perception of vaginal laxity on the Vaginal Laxity Questionnaire |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- referred by gynecologists from the outpatient clinic for gynecology, Minia university Hospital, Minia, Egypt.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluating sexual function, quality of life and pelvic floor muscle strength, as well as thickness and force (strength) of voluntary contractions of the core musclesEvaluation through Vaginal Laxity Questionnaire, Female Sexual Function Index, Short-Form 36 Health Survey, modified Oxford grading scale and ultrasound imaging | Other | normal subjects without vaginal laxity, women suffering from vaginal laxity |
Primary outcome
ِ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.
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.
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.
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.
4 secondary outcomes
Vaginal Laxity Questionnaire
Time frame: 3 months
The Female Sexual Function Index (FSFI)
Time frame: 3 months
Short-Form 36 Health Survey (SF-36)
Time frame: 3 months
Modified Oxford grading scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Osman, Assis. Prof. principal investigator
Physical Therapy for Woman's Health, Faculty of physical therapy, Cairo University, Giza, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Laxity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ِAssessment of diaphragmatic force (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.