Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525207
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to evaluate the pressure and distensibility index of the anal sphincter complex using high-definition anorectal manometry and the Impedance Planimetry system in women with fecal incontinence or constipation as well as in a group of healthy volunteer women The main questions it aims to answer are
Assess the diagnostic accuracy of the Impedance Planimetry system compared to high-definition anorectal manometry HD-ARM in patients with anal incontinence and obstructive defecation
Evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using HD-ARM to identify anal sphincter complex lesions compared to pelvic floor ultrasonography
Determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales
Participants will undergo the following tasks
Undergo high-definition anorectal manometry and Impedance Planimetry testing
Undergo pelvic floor ultrasonography to assess structural and functional aspects
Complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation
Assess the diagnostic accuracy of the Impedance Planimetry system compared to high-definition anorectal manometry HD-ARM in patients with anal incontinence and obstructive defecation
Evaluate the diagnostic accuracy of three-dimensional reconstruction of the anal sphincter complex using HD-ARM to identify anal sphincter complex lesions compared to pelvic floor ultrasonography
Determine the impact on the quality of life in women with anal incontinence and obstructive defecation based on the severity of symptoms assessed by validated scales
Participants will undergo the following tasks
Undergo high-definition anorectal manometry and Impedance Planimetry testing
Undergo pelvic floor ultrasonography to assess structural and functional aspects
Complete validated scales to assess symptoms and quality of life related to anal incontinence and obstructive defecation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None