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

Fecal Incontinence Clinical Trial

— MANOPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05058326
• Other study ID #: 052020
• Status: Completed
• Start date: September 20, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: March 2022
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence
• Incontinence, Urge
• Urinary Incontinence, Urge

Intervention

Diagnostic Test:
• 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.

Other:
• Incontinence severity scale questionaires
Wexner and St. Mark's scales.

Locations

Country	Name	City	State
Spain	Hospital Universitari Dr. Josep Trueta de Girona	Girona	Catalunya

Sponsors (1)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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