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Not Yet RecruitingNCT07517978

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
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTTransperineal 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.

Timeline

Start date
2026-06-01
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2026-04-08
Last updated
2026-04-13

Source: ClinicalTrials.gov record NCT07517978. Inclusion in this directory is not an endorsement.