Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous WomenVLBNDUSNCT07491224
Evaluation of Vaginal Laxity and Bladder Neck Descent in Parous Women Using 2D and 3D Transperineal Ultrasound
An observational study of Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women, run by Assiut University.
Trial summary
This study aims to evaluate vaginal laxity and bladder neck descent in women who have given birth, using non-invasive 2D and 3D transperineal ultrasound. Participants will complete a short questionnaire about pelvic floor symptoms and undergo a pelvic examination. 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
- Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 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: The study population consists of parous women attending the Women's Health Hospital, Urogynecology and Advanced Ultrasound units. Participants will include women with at least one vaginal delivery or only cesarean deliveries, aged 18 years or older. They will be recruited to assess pelvic floor function and anatomical changes using 2D and 3D transperineal ultrasound.
Who may be able to join
- Parous women aged 18 years or older
- Willing to provide informed consent
- Able to complete the Pelvic Floor Distress Inventory-20 questionnaire
- Undergo 2D and 3D transperineal ultrasound and POP-Q examination
Who cannot join
- Pregnant women
- History of previous prolapse surgery
- Patients with neurological disorders affecting pelvic floor function
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ola Abd El Hares Mahros Ali resistant Obstetrics & Gynecology Department Assiut University contact
About this study
This study aims to evaluate vaginal laxity and bladder neck descent in women who have given birth, using non-invasive 2D and 3D transperineal ultrasound. Participants will complete a short questionnaire about pelvic floor symptoms and undergo a pelvic examination. The ultrasound will measure bladder neck position, levator hiatus dimensions, and related pelvic floor structures at rest and during straining. The study will compare findings between women with previous vaginal deliveries and those who had cesarean sections. Participation is voluntary, and all procedures are safe, non-invasive, and similar to routine clinical practice. The results will help better understand pelvic floor changes after childbirth and may improve the management of pelvic floor disorders.
Read the detailed description
Pelvic floor dysfunction is a common condition affecting women after childbirth, often resulting in vaginal laxity, bladder neck descent, and related pelvic floor symptoms such as urinary incontinence and sexual dysfunction. This observational cross-sectional study will assess 185 parous women, aged 18 years or older, using both 2D and 3D transperineal ultrasound. Participants will complete the Pelvic Floor Distress Inventory-20 questionnaire and undergo a pelvic examination using the POP-Q system after bladder emptying. Ultrasound measurements will include bladder neck height, retrovesical angle, levator hiatal dimensions, levator ani muscle integrity, and other related parameters at rest and during Valsalva maneuver. Women will be categorized based on mode of delivery (vaginal vs cesarean) and results will be analyzed to determine correlations between pelvic floor anatomy and symptom severity. The study aims to provide a comprehensive understanding of pelvic floor alterations in parous women, which may inform clinical assessment and management strategies for pelvic floor dysfunction.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Delivery (VD) | Women who have had at least one vaginal delivery. Participants will undergo pelvic floor evaluation including 2D and 3D transperineal ultrasound, complete the Pelvic Floor Distress Inventory-20 questionnaire, and undergo POP-Q clinical examination. No therapeutic interventions are assigned. | |
| Cesarean Section (CS) | Women who have had only cesarean deliveries. Participants will undergo pelvic floor evaluation including 2D and 3D transperineal ultrasound, complete the Pelvic Floor Distress Inventory-20 questionnaire, and undergo POP-Q clinical examination. No therapeutic interventions are assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levator Hiatal Area
Levator hiatal area will be measured using 2D and 3D transperineal ultrasound in the midsagittal plane. Measurements will be taken at rest and during maximal Valsalva maneuver to assess pelvic floor anatomy in parous women and compare between vaginal delivery and cesarean section groups.
Measured: Measured once during ultrasound assessment after bladder emptying
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous WomenStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Abd El Hares Mahros Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491224
- Sponsor's protocol ID
- VaginalLaxity_US_2026
- Acronym
- VLBNDUS
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 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
- NCT07491224
- Acronym / sponsor ID
- VLBNDUS / VaginalLaxity_US_2026
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 24 Mar 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.
This study aims to evaluate vaginal laxity and bladder neck descent in women who have given birth, using non-invasive 2D and 3D transperineal ultrasound. Participants will complete a short questionnaire about pelvic floor symptoms and undergo a pelvic examination. The ultrasound will measure bladder neck position, levator hiatus dimensions, and related pelvic floor structures at rest and during straining. The study will compare findings between women with previous vaginal deliveries and those who had cesarean sections. Participation is voluntary, and all procedures are safe, non-invasive, and similar to routine clinical practice. The results will help better understand pelvic floor changes after childbirth and may improve the management of pelvic floor disorders.
Detailed description
Pelvic floor dysfunction is a common condition affecting women after childbirth, often resulting in vaginal laxity, bladder neck descent, and related pelvic floor symptoms such as urinary incontinence and sexual dysfunction. This observational cross-sectional study will assess 185 parous women, aged 18 years or older, using both 2D and 3D transperineal ultrasound. Participants will complete the Pelvic Floor Distress Inventory-20 questionnaire and undergo a pelvic examination using the POP-Q system after bladder emptying. Ultrasound measurements will include bladder neck height, retrovesical angle, levator hiatal dimensions, levator ani muscle integrity, and other related parameters at rest and during Valsalva maneuver. Women will be categorized based on mode of delivery (vaginal vs cesarean) and results will be analyzed to determine correlations between pelvic floor anatomy and symptom severity. The study aims to provide a comprehensive understanding of pelvic floor alterations in parous women, which may inform clinical assessment and management strategies for pelvic floor dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Delivery (VD) | – | –Women who have had at least one vaginal delivery. Participants will undergo pelvic floor evaluation including 2D and 3D transperineal ultrasound, complete the Pelvic Floor Distress Inventory-20 questionnaire, and undergo POP-Q clinical examination. No therapeutic interventions are assigned. |
| Cesarean Section (CS) | – | –Women who have had only cesarean deliveries. Participants will undergo pelvic floor evaluation including 2D and 3D transperineal ultrasound, complete the Pelvic Floor Distress Inventory-20 questionnaire, and undergo POP-Q clinical examination. No therapeutic interventions are assigned. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of parous women attending the Women's Health Hospital, Urogynecology and Advanced Ultrasound units. Participants will include women with at least one vaginal delivery or only cesarean deliveries, aged 18 years or older. They will be recruited to assess pelvic floor function and anatomical changes using 2D and 3D transperineal ultrasound.
Key inclusion criteria (4 listed)
- Parous women aged 18 years or older
- Willing to provide informed consent
- Able to complete the Pelvic Floor Distress Inventory-20 questionnaire
- Undergo 2D and 3D transperineal ultrasound and POP-Q examination
Key exclusion criteria (3 listed)
- Pregnant women
- History of previous prolapse surgery
- Patients with neurological disorders affecting pelvic floor function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Levator Hiatal Area
Time frame: Measured once during ultrasound assessment after bladder emptying
Levator hiatal area will be measured using 2D and 3D transperineal ultrasound in the midsagittal plane. Measurements will be taken at rest and during maximal Valsalva maneuver to assess pelvic floor anatomy in parous women and compare between vaginal delivery and cesarean section groups.
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 24 Mar 2026.
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.
Ola Abd El Hares Mahros Ali resistant Obstetrics & Gynecology Department Assiut University contact
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women, run by Assiut University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ola Abd El Hares Mahros Ali resistant Obstetrics & Gynecology Department Assiut University (01158002972, drola6181@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levator Hiatal Area (time frame: Measured once during ultrasound assessment after bladder emptying). 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 24 Mar 2026.