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

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta41 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Fecal Incontinence Anal; Sphincter, Incontinence Incontinence, Urge

Interventions

Portable endoanal manometryDIAGNOSTIC_TEST

Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.

Endoanal ultrasoundDIAGNOSTIC_TEST

To assess the integrity of the anal canal.

Incontinence severity scale questionairesOTHER

Wexner and St. Mark's scales.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Catalonia, Spain

Outcomes

Primary Outcomes

Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence

Spearman and Pearson correlation will be used to assess correlations between values

Time frame: During the procedure

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

Spearman and Pearson correlation will be used to assess correlations between values

Time frame: During the procedure

Secondary Outcomes

Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence

Spearman and Pearson correlation will be used to assess correlations between values

Time frame: During the procedure

Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence

Spearman and Pearson correlation will be used to assess correlations between values

Time frame: During the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.