Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
NCT ID: NCT05058326
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
41 participants
OBSERVATIONAL
2020-09-20
2021-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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TEST GROUP
Women with fecal incontinence referred to outpatients clinic.
Portable endoanal manometry
Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.
Endoanal ultrasound
To assess the integrity of the anal canal.
Incontinence severity scale questionaires
Wexner and St. Mark's scales.
Interventions
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Portable endoanal manometry
Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.
Endoanal ultrasound
To assess the integrity of the anal canal.
Incontinence severity scale questionaires
Wexner and St. Mark's scales.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Informed consent signed by the patient and the researcher.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
OTHER
Responsible Party
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Locations
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Hospital Universitari Dr. Josep Trueta de Girona
Girona, Catalonia, Spain
Countries
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Other Identifiers
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052020
Identifier Type: -
Identifier Source: org_study_id
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