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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Incontinence, Urge, Fecal Incontinence, Anal; Sphincter, Incontinence

Intervention / Treatment
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* Diagnostic Test: Portable endoanal manometry
* Diagnostic Test: Endoanal ultrasound
* Other: Incontinence severity scale questionaires


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TEST GROUP<br>Women with fecal incontinence referred to outpatients clinic. | Diagnostic Test: Portable endoanal manometry<br>* Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.<br>Diagnostic Test: Endoanal ultrasound<br>* To assess the integrity of the anal canal.<br>Other: Incontinence severity scale questionaires<br>* Wexner and St. Mark's scales.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | During the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anal manometry, Anal portable manometry, Fecal incontinence severity, Endoanal ultrasound