Anal Incontinence After Obstetrical Anal Sphincter Injury

NCT04940494 | Completed

• 1 other identifier: 2021-A01128-33
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstetric Trauma; Anal Sphincter Injury; Anal Incontinence

Outcome Measures

Primary Outcomes (1)

• anal incontinence

  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 Outcomes (4)

• Incidence of anal incontinence

  Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)

• cinetic of AI occurence

  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

  the date of the survey (2 to 16 years after childbirth)

• Expectation of the women in term of information

  the date of the survey (2 to 16 years after childbirth)

Interventions

collection of data OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, France

Location

Related Publications (1)

• Rebmann E, Hamel JF, Helbert C, Lemasson F, Legendre G, Venara A. Anal incontinence after obstetrical anal sphincter injury significantly impacts quality of life for women: a cohort study. Langenbecks Arch Surg. 2024 Feb 17;409(1):67. doi: 10.1007/s00423-024-03257-4.

  PMID: 38368278 DERIVED

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Officials

• Aurélien VENARA, M.D.

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: July 1, 2021
• Primary Completion: July 6, 2022
• Study Completion: July 6, 2022
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)