Anal Incontinence After Obstetrical Anal Sphincter Injury (INCONT-LOSA)

November 17, 2025 updated by: University Hospital, Angers

Incidence and Risk Factors for Anal Incontinence After Obstetrical Anal Sphincter Injury

Obstetrical Anal Sphincter Injury is an identified risk factor for anal incontinence. The mechanisms and the risk factors for anal incontinence in Obstetrical Anal Sphincter Injury women are not well known.

Anal incontinence in such women is not well documented and probably underestimated. Cohort studies estimated that up to 53% of Obstetrical Anal Sphincter Injury women are incontinent but that most of them does not complain their doctor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All women that gave birth between 2005 January 1st and 2019 December 31th and that accept to respond to the survey

Description

Inclusion Criteria:

  • Childbirth between 2005 January 1st and 2019 December 31th
  • Obstetrical Anal Sphincter Injury -≥ 18 y

Exclusion Criteria:

  • Patients' refusal
  • lost of view or deceased
  • anal incontinence before the Obstetrical Anal Sphincter Injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anal incontinence
Time Frame: from the childbirth to the day of survey (2 to 16 years after childbirth)
loss of stool or gas ≥1/week during ≥1 month
from the childbirth to the day of survey (2 to 16 years after childbirth)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of anal incontinence
Time Frame: Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)
AI graded by the St Mark Score
Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)
cinetic of AI occurence
Time Frame: from the childbirth to the date of the survey (2 to 16 years after childbirth)
all the resolutive episodes of occurence of anal incontinence are reported
from the childbirth to the date of the survey (2 to 16 years after childbirth)
Quality of life with fecal incontinence quality of life score
Time Frame: the date of the survey (2 to 16 years after childbirth)
fecal incontinence quality of life score
the date of the survey (2 to 16 years after childbirth)
Expectation of the women in term of information
Time Frame: the date of the survey (2 to 16 years after childbirth)
2 questions on the expectation of the women in term of information towards the Obstetrical Anal Sphincter Injury
the date of the survey (2 to 16 years after childbirth)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Aurélien VENARA, M.D., University hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 6, 2022

Study Completion (Actual)

July 6, 2022

Study Registration Dates

First Submitted

June 17, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 25, 2021

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A01128-33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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