NCT07517978

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

April 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 26, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 2, 2026

Last Update Submit

June 26, 2026

Conditions

Vaginal Laxity

Keywords

Transperineal Ultrasoundvaginal haituspelvic floor musclesBladder neck descent

Outcome Measures

Primary Outcomes (1)

  • Levator Haital area after VD or CS

    Increased area means increase vaginal laxity

    1 day

Study Arms (2)

Group 1

Vaginal delivery

Diagnostic Test: Transperineal Ultrasound

Group 2

Cesarean section

Diagnostic Test: Transperineal Ultrasound

Interventions

Transperineal UltrasoundDIAGNOSTIC_TEST

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 1Group 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • parous women

You may not qualify if:

  • pregnant women
  • previous prolapse surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Health Hospital

Asyut, Egypt

RECRUITING

Study Officials

  • Women H Hospital

    Women's health hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Fekry, PhD

CONTACT

200882312388mohamedbeethoven2040@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer obstetric and gynecology, Specialist Urogynecology

Study Record Dates

First Submitted

April 2, 2026

First Posted

April 8, 2026

Study Start

June 26, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 30, 2026

Record last verified: 2026-04

Locations

EG(1)