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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05058326
Acronym
MANOPRESS
Enrollment
41
Registered
2021-09-27
Start date
2020-09-20
Completion date
2021-10-01
Last updated
2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Anal manometry, Anal portable manometry, Fecal incontinence severity, Endoanal ultrasound

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.

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.

Interventions

DIAGNOSTIC_TESTPortable endoanal manometry

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

DIAGNOSTIC_TESTEndoanal ultrasound

To assess the integrity of the anal canal.

OTHERIncontinence severity scale questionaires

Wexner and St. Mark's scales.

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinenceDuring the procedureSpearman 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 incontinenceDuring the procedureSpearman and Pearson correlation will be used to assess correlations between values

Secondary

MeasureTime frameDescription
Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinenceDuring the procedureSpearman 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 incontinenceDuring the procedureSpearman and Pearson correlation will be used to assess correlations between values

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026