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OpenTrials
Completed

NCT Number: NCT04940494

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.

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Key information

Conditions

Obstetric Trauma Anal Incontinence Anal Sphincter Injury Behavior Behavioral Symptoms Elimination Disorders Encopresis Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

CHU Angers

Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of data

Other

collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: INCONT-LOSA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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