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

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (Other)

Overall Status

Completed

CT.gov ID

NCT05058326

Collaborator

(none)

Enrollment

Location

12.4

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Fecal Incontinence Anal; Sphincter, Incontinence Incontinence, Urge	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

41 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 20, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence [During the procedure]
Spearman and Pearson correlation will be used to assess correlations between values
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 [During the procedure]
Spearman and Pearson correlation will be used to assess correlations between values

Secondary Outcome Measures

Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence [During the procedure]
Spearman and Pearson correlation will be used to assess correlations between values
Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence [During the procedure]
Spearman and Pearson correlation will be used to assess correlations between values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.