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Pelvic Floor Muscle Assessment at 3-and 4-dimensional Transperineal Ultrasound

NCT03950479 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2019-05-15

No results posted yet for this study

Summary

Injuries to the pelvic floor muscles and fascias during delivery and childbirth may lead to urinary incontinence (25-45 %), faecal incontinence (11-45%), pelvic organ prolapse (7-23%), sexual dysfunction (15-33 %) and chronic pain syndromes (4-15%). Pelvic floor muscle injuries are not easy to diagnose as they are not visible when looking at surface anatomy during a standard gynaecological examination. The investigators are therefore in urgent need of better tools to diagnose these injuries. Having a reliable and easily accessible tool enables studies of the consequences of such pelvic floor muscle injuries. It also makes it possible for us to explore the effect of interventions such as pelvic floor muscle training and surgery in patients with and without pelvic floor muscle injuries. The investigators have previously presented data to support the reliability and the validity of the three and four dimensional (3 and 4D) ultrasound technique used to define pelvic floor muscle anatomy in healthy volunteers and have now a tool to study women before and after delivery.

Conditions

  • Pelvic Floor Disorders

Interventions

DIAGNOSTIC_TEST

3D and 4D Transperineal Ultrasound

The evaluation of Pelvic Floor Muscles with 3D and 4D transperineal ultrasound using A Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer for all acquisitions. Measurements will be performed in axial planes. The levator hiatus area (LHA), the antero-posterior (AP) diameter and the left-right (LR) transverse diameter will be analyzed at rest, during pelvic floor contraction and on maximal Valsalva maneuver.

Sponsors & Collaborators

  • Wuerzburg University Hospital

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY, MD · Cairo University

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-15
Primary Completion
2024-06-01
Completion
2024-10-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03950479 on ClinicalTrials.gov