NCT05058326

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

September 13, 2021

Last Update Submit

March 29, 2022

Conditions

Fecal IncontinenceAnal; Sphincter, IncontinenceIncontinence, Urge

Keywords

Anal manometryAnal portable manometryFecal incontinence severityEndoanal ultrasound

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Stablish a correlation between St.Mark's fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence

    During the procedure

  • Stablish a correlation between Wexner fecal incontinence severity scales and values obtained using endoanal ultrasound in women with fecal incontinence

    During the procedure

Study Arms (1)

TEST GROUP

Women with fecal incontinence referred to outpatients clinic.

Diagnostic Test: Portable endoanal manometryDiagnostic Test: Endoanal ultrasoundOther: Incontinence severity scale questionaires

Interventions

Portable endoanal manometryDIAGNOSTIC_TEST

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

TEST GROUP
Endoanal ultrasoundDIAGNOSTIC_TEST

To assess the integrity of the anal canal.

TEST GROUP
Incontinence severity scale questionairesOTHER

Wexner and St. Mark's scales.

TEST GROUP

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women over 18 years referred to our outpatient's clinic with the clinical diagnosis of fecal incontinence.

You may qualify if:

  • Patients with the clinical diagnosis of fecal incontinence
  • Age ≥ 18 years.
  • Informed consent signed by the patient and the researcher.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Dr. Josep Trueta de Girona

Girona, Catalonia, 17007, Spain

Location

MeSH Terms

Conditions

Fecal IncontinenceUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesUrinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

September 27, 2021

Study Start

September 20, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)