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Recruiting NCT07517978

Correlation Between Vaginal Laxity and Delivery Mode

Observational Vaginal Laxity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transperineal Ultrasound.
Who it may be relevant to
Registry conditions: Vaginal Laxity. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Diagnostic test Transperineal Ultrasound
    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 Mea

Primary outcome measures

  • Levator Haital area after VD or CS [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • parous women

Exclusion criteria

  • pregnant women
  • previous prolapse surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-crossover

Study locations

Egypt · 1 center
  • Women's Health Hospital — Asyut

Identifiers

NCT: NCT07517978 · VL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗