NCT06525207

New Diagnostic Tools in the Evaluation of the Posterior Compartment of the Women Pelvic Floor

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anal Incontinence
• Obstructive Defecation

Interventions

Type	Name	Description
DEVICE	Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography	Global morpho-functional assessment of the anal sphincter complex using Impedance Planimetry, High-definition anorectal manometry and Pelvic Floor Ultrasonography

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2024-07-29
• Last updated: 2024-10-09

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study