Clinical trial NCT05058326: Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Official title: Severity of Fecal Incontinence and Manometric Values Using the Anopress® Device in Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fecal Incontinence
Anal; Sphincter, Incontinence
Incontinence, Urge
Keywords: Anal manometry
Anal portable manometry
Fecal incontinence severity
Endoanal ultrasound
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2021-09-27
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years referred to our outpatient's clinic with the clinical diagnosis of fecal incontinence.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stablish a correlation between Wexner fecal incontinence severity scales and manometric values obtained using the Anopress® portable manometry in women with fecal incontinence
timeFrame: During the procedure
measure: 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
timeFrame: During the procedure
Secondary outcomes:
measure: Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
timeFrame: During the procedure
measure: Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence
timeFrame: During the procedure
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta de Girona
state: Catalunya
Study officials:
References: