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

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.

Study Overview

• Status: Completed
• Conditions: Fecal Incontinence; Anal; Sphincter, Incontinence; Incontinence, Urge
• Intervention / Treatment: Diagnostic test: Portable endoanal manometry; Diagnostic test: Endoanal ultrasound; Other: Incontinence severity scale questionaires

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 Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Spain
  • Catalunya
    • Girona, Catalunya, Spain, 17007
      • Hospital Universitari Dr. Josep Trueta de Girona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years referred to our outpatient's clinic with the clinical diagnosis of fecal incontinence.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Anal manometry; Anal portable manometry; Fecal incontinence severity; Endoanal ultrasound
• Additional Relevant MeSH Terms: Digestive System Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Gastrointestinal Diseases; Urination Disorders; Intestinal Diseases; Rectal Diseases; Urinary Incontinence; Fecal Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: 052020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No