Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women

Completed

• Conditions: Fecal Incontinence; Incontinence, Urge; Anal; Sphincter, Incontinence
• Interventions: Diagnostic Test: Portable endoanal manometry; Diagnostic Test: Endoanal ultrasound; Other: Incontinence severity scale questionaires

• Registration Number: NCT05058326
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief Summary

The purpose of this study is to stablish a correlation between fecal incontinence severity scales (Wexner \& St. Mark's) and manometric values obtained using the Anopress® portable manometry and values obtained using endoanal ultrasound in women with fecal incontinence.

Detailed Description

The Anopress® portable anal manometry will be used to measure the pressures of the anal canal in different phases: rest, squeeze, strain and endurance.

All female patients referred with the diagnosis of fecal incontinence giving written informed consent will undergo a endoanal portable manometry at our outpatients clinics. They will be asked to fill out the severity questionaries (Sant Mark's and Wexner). All data will be collected for analysis.

An endoanal ultrasound will be performed in all patients to assess the sphincter integrity.

Study Timeline

• Study Start: 2020-09-20
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-09-27
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-29
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• Patients with the clinical diagnosis of fecal incontinence
• Age ≥ 18 years.
• Informed consent signed by the patient and the researcher.

Exclusion Criteria

• Patients with psychiatric illnesses, addictions or any disorder that prevents understanding of the study.
• Inability to read or understand the questionnaires.
• Inability to read or understand any of the informed consent languages (Catalan, Spanish).
• Any patient who, due to his medical characteristics, presents a high individual risk when being included and completing the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEST GROUP	Incontinence severity scale questionaires	Women with fecal incontinence referred to outpatients clinic.
TEST GROUP	Portable endoanal manometry	Women with fecal incontinence referred to outpatients clinic.
TEST GROUP	Endoanal ultrasound	Women with fecal incontinence referred to outpatients clinic.

Primary Outcome Measures

Name	Time	Method
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence	During the procedure	Spearman and Pearson correlation will be used to assess correlations between values
Stablish a correlation between St. Mark's fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence	During the procedure	Spearman and Pearson correlation will be used to assess correlations between values

Secondary Outcome Measures

Name	Time	Method
Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence	During the procedure	Spearman and Pearson correlation will be used to assess correlations between values
Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence	During the procedure	Spearman and Pearson correlation will be used to assess correlations between values

Trial Locations

Locations (1)

Hospital Universitari Dr. Josep Trueta de Girona; 🇪🇸 Girona, Catalunya, Spain