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Not yet recruiting NCT07491224

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

Observational Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women. 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Levator Hiatal Area [Time frame: Measured once during ultrasound assessment after bladder emptying]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnant women
  • History of previous prolapse surgery
  • Patients with neurological disorders affecting pelvic floor function

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
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07491224 · VaginalLaxity_US_2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗