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

NCT06525207 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2024-10-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-09-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • Spain

Study Locations

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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 NCT06525207 on ClinicalTrials.gov