Evaluation of Levator Injuries Using Transvaginal Endosonography (ELITE)
|ClinicalTrials.gov Identifier: NCT01310660|
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : February 1, 2016
Prospective studies to date have identified that the levator ani muscle injuries occur in 14-19% of women after vaginal delivery.
In none of studies a vaginal examination was performed at the time of delivery. It has previously been shown that sonographic injuries of the anal sphincter that were believed to be occult were in fact clinically apparent but not recognised at the time of delivery. It is therefore important to correlate clinical findings to ultrasound images.
3D endovaginal endosonography has not previously been used to identify levator injuries. This should potentially provide a better view of the pelvic floor muscles.
The relationship between levator injury and symptoms of pelvic floor dysfunction has not been previously established using validated questionnaires. In this study, we include validated questionnaires to evaluate urinary incontinence, faecal incontinence and vaginal symptoms. As symptoms may become apparent only in the long term it is prudent that the women are followed up in the long term.
The principle objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. The levator muscle forms a major part of the pelvic floor and damage to this muscle can potentially cause urinary, bowel and sexual problems and pelvic organ prolapse.
|Condition or disease|
|Childbirth Related Levator Injuries|
|Study Type :||Observational|
|Actual Enrollment :||269 participants|
|Official Title:||Evaluation of Levator Injuries Using Transvaginal Endosonography|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2013|
- The principal objective is to establish the incidence of levator muscle defects during pregnancy and after childbirth. [ Time Frame: Antenatal, after delivery and postnatal ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310660
|Croydon University Hospital|
|Croydon, Surrey, United Kingdom, CR7 7YE|