Vaginal LaxityNCT07517978
Correlation Between Vaginal Laxity and Delivery Mode
An observational study of Vaginal Laxity, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Laxity
- What is being tested?
- Transperineal Ultrasound
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jun 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parous women who have history of previous delivery either vaginal, operative vaginal or Cesarean section
Who may be able to join
- parous women
Who cannot join
- pregnant women
- previous prolapse surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Women's Health Hospital
Asyut
Women Hospital, 0882414916, ethics_committee12@yahoo.com
About this study
Official title: Evaluation of Vaginal Laxity and Bladder Neck Descent in Parous Women Using 2D and 3D Transperineal Ultrasound
Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound
Read the detailed description
Pelvic floor dysfunction (PFD) is a prevalent condition affecting women worldwide and includes pelvic organ prolapse, stress urinary incontinence (SUI), fecal incontinence, sexual dysfunction, and vaginal laxity. Vaginal laxity is increasingly recognized as a distressing symptom negatively affecting quality of life and sexual satisfaction. It has been strongly associated with levator ani muscle overstretching and enlargement of the levator hiatus, particularly following vaginal delivery.
Pregnancy and childbirth are major contributors to pelvic floor trauma [2]. Vaginal delivery may result in levator ani muscle injury, bladder neck descent, urethral hypermobility, and widening of the levator hiatus. These anatomical alterations predispose women to stress urinary incontinence and pelvic floor weakness.
Transperineal ultrasound has emerged as a reliable, non-invasive, and reproducible modality for assessing pelvic floor structures. Two- and three-dimensional ultrasound techniques allow accurate measurement of bladder neck mobility, retrovesical angle, levator hiatus dimensions, and levator ani integrity during rest and Valsalva maneuver.
However, limited studies have addressed the combined evaluation of vaginal laxity and bladder neck descent using both 2D and 3D transperineal ultrasound in parous women. Therefore, this study aims to evaluate these parameters and correlate them with mode of delivery and pelvic floor dysfunction symptoms
- Conditions
- Vaginal Laxity
- Being tested
- Transperineal Ultrasound
- Keywords
- Transperineal Ultrasound, vaginal haitus, pelvic floor muscles, Bladder neck descent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal UltrasoundDiagnostic test
patients were asked to fill the Pelvic Floor Distress Inventory Questionnaire - Short Form 20. The imaging was performed using a GE Voluson S8 machine. A conventional linear 2D transducer (5-8 MHz) with a field of view of at least 70° was used. For tomographic or multi-slice imaging, a volumetric probe (6-8 MHz) was employed.
2D measures: Bladder neck height ( BN) , Retrovesical angle (RVA) at rest and valsalva, Bladder wall Thickness (BWT), Post micturition Residual volume. For 3D measures Measurements were analyzed offline, assessing the levator hiatal anteroposterior and transverse diameters, Levator Haital area (LHA), Pubovisceral muscle thickness at 3 and 9 o'clock, Pubovisceral muscle length, right and left levator urethral gap and urethral anal distance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Vaginal delivery Receives: Diagnostic Test: Transperineal Ultrasound | |
| Group 2 | Cesarean section Receives: Diagnostic Test: Transperineal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levator Haital area after VD or CS
Increased area means increase vaginal laxity
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start26 Jun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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 Assiut 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
- Investigators
- Women H Hospital, Principal investigator, Women's health hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517978
- Sponsor's protocol ID
- VL
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vaginal Laxity and Bladder Neck Descent in Parous Women Using 2D and 3D Transperineal Ultrasound
- ClinicalTrials.gov ID
- NCT07517978
- Acronym / sponsor ID
- VL
- Conditions
- Vaginal Laxity
- Keywords
- Transperineal Ultrasound, vaginal haitus, pelvic floor muscles, Bladder neck descent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Apr 2026 (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.
Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound
Detailed description
Pelvic floor dysfunction (PFD) is a prevalent condition affecting women worldwide and includes pelvic organ prolapse, stress urinary incontinence (SUI), fecal incontinence, sexual dysfunction, and vaginal laxity. Vaginal laxity is increasingly recognized as a distressing symptom negatively affecting quality of life and sexual satisfaction. It has been strongly associated with levator ani muscle overstretching and enlargement of the levator hiatus, particularly following vaginal delivery.
Pregnancy and childbirth are major contributors to pelvic floor trauma [2]. Vaginal delivery may result in levator ani muscle injury, bladder neck descent, urethral hypermobility, and widening of the levator hiatus. These anatomical alterations predispose women to stress urinary incontinence and pelvic floor weakness.
Transperineal ultrasound has emerged as a reliable, non-invasive, and reproducible modality for assessing pelvic floor structures. Two- and three-dimensional ultrasound techniques allow accurate measurement of bladder neck mobility, retrovesical angle, levator hiatus dimensions, and levator ani integrity during rest and Valsalva maneuver.
However, limited studies have addressed the combined evaluation of vaginal laxity and bladder neck descent using both 2D and 3D transperineal ultrasound in parous women. Therefore, this study aims to evaluate these parameters and correlate them with mode of delivery and pelvic floor dysfunction symptoms
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Transperineal UltrasoundVaginal delivery |
| Group 2 | – | Diagnostic Test: Transperineal UltrasoundCesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parous women who have history of previous delivery either vaginal, operative vaginal or Cesarean section
Key inclusion criteria (1 listed)
- parous women
Key exclusion criteria (2 listed)
- pregnant women
- previous prolapse surgery
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 |
|---|---|---|
| Transperineal Ultrasoundpatients were asked to fill the Pelvic Floor Distress Inventory Questionnaire - Short Form 20. The imaging was performed using a GE Voluson S8 machine. A conventional linear 2D transducer (5-8 MHz) with a field of view of at least 70° was used. For tomographic or multi-slice imaging, a volumetric probe (6-8 MHz) was employed. 2D measures: Bladder neck height ( BN) , Retrovesical angle (RVA) at rest and valsalva, Bladder wall Thickness (BWT), Post micturition Residual volume. For 3D measures Measurements were analyzed offline, assessing the levator hiatal anteroposterior and transverse diameters, Levator Haital area (LHA), Pubovisceral muscle thickness at 3 and 9 o'clock, Pubovisceral muscle length, right and left levator urethral gap and urethral anal distance. | Diagnostic test | Group 1, Group 2 |
Primary outcome
Levator Haital area after VD or CS
Time frame: 1 day
Increased area means increase vaginal laxity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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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.
Women H Hospital principal investigator
Women's health hospital
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 Assiut 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fekry, PhD (200882312388, mohamedbeethoven2040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levator Haital area after VD or CS (time frame: 1 day). 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 30 Jun 2026.