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Correlation Between Vaginal Laxity and Delivery Mode

Evaluation of Vaginal Laxity and Bladder Neck Descent in Parous Women Using 2D and 3D Transperineal Ultrasound

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07517978
Enrollment
150
Registered
2026-04-08
Start date
2026-06-26
Completion date
2027-12-01
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Laxity

Keywords

Transperineal Ultrasound, vaginal haitus, pelvic floor muscles, Bladder neck descent

Brief summary

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

Interventions

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* parous women

Exclusion criteria

* pregnant women * previous prolapse surgery

Design outcomes

Primary

MeasureTime frameDescription
Levator Haital area after VD or CS1 dayIncreased area means increase vaginal laxity

Countries

Egypt

Contacts

CONTACTMohamed Fekry, PhD
mohamedbeethoven2040@gmail.com200882312388
PRINCIPAL_INVESTIGATORWomen H Hospital

Women's health hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026