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Completed

NCT Number: NCT05058326

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

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.

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Key information

Conditions

Fecal Incontinence Anal; Sphincter, Incontinence Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Incontinence, Urge Intestinal Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Catalonia, 17007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Portable endoanal manometry

Diagnostic Test

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

Endoanal ultrasound

Diagnostic Test

To assess the integrity of the anal canal.

Incontinence severity scale questionaires

Other

Wexner and St. Mark's scales.

Primary outcomes

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

    Time frame: During the procedure

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

  2. 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

    Time frame: During the procedure

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

Secondary outcomes

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

    Time frame: During the procedure

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

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

    Time frame: During the procedure

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

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Acronym: MANOPRESS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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