Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-29 @ 11:09 PM
Study NCT ID:
NCT01310660
Status:
COMPLETED
Last Update Posted:
2016-02-01
First Post:
2011-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Levator Injuries Using Transvaginal Endosonography
Sponsor:
Croydon University Hospital
Organization:
Study Overview
Official Title:
Evaluation of Levator Injuries Using Transvaginal Endosonography
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELITE
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: