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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Floor Dysfunction; Vaginal Laxity; Bladder Neck Descent in Parous Women

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 Type: Observational
• Enrollment (Estimated): 185

Contacts and Locations

• Study Contact: Name: Ola Abd El Hares Mahros Ali resistant Obstetrics & Gynecology Department Assiut University; Phone Number: 01158002972; Email: drola6181@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 once during ultrasound assessment after bladder emptying

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VaginalLaxity_US_2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No