NCT05058326

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 41 (actual)
• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Fecal Incontinence
• Anal; Sphincter, Incontinence
• Incontinence, Urge

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-20
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2021-09-27
• Last updated: 2022-03-31

Locations

1 site across 1 country: Spain