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

I

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status

Completed

Conditions

Incontinence, Urge
Anal; Sphincter, Incontinence
Fecal Incontinence

Treatments

Diagnostic Test: Endoanal ultrasound
Other: Incontinence severity scale questionaires
Diagnostic Test: Portable endoanal manometry

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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.

Trial design

41 participants in 1 patient group

TEST GROUP
Description:
Women with fecal incontinence referred to outpatients clinic.
Treatment:
Diagnostic Test: Endoanal ultrasound
Other: Incontinence severity scale questionaires
Diagnostic Test: Portable endoanal manometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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