Correlation Between Vaginal Laxity and Delivery Mode

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

Evaluation of pelvic floor using 2D and 3D Transperineal Ultrasound

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Laxity
• Intervention / Treatment: Diagnostic test: 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

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Mohamed Fekry, PhD; Phone Number: 200882312388; Email: mohamedbeethoven2040@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Parous women who have history of previous delivery either vaginal, operative vaginal or Cesarean section

Description

Inclusion Criteria:

• parous women

Exclusion Criteria:

• pregnant women
• previous prolapse surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Vaginal delivery	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 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.
Group 2; Cesarean section	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levator Haital area after VD or CS	Increased area means increase vaginal laxity	1 day

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Women H Hospital, Women's Health Hospital

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pelvic floor muscles; Transperineal Ultrasound; vaginal haitus; Bladder neck descent
• Other Study ID Numbers: VL

Drug and device information, study documents

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