Anal Incontinence After Obstetrical Anal Sphincter Injury

• Conditions: Anal Incontinence; Obstetric Trauma; Anal Sphincter Injury

• Registration Number: NCT04940494
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-17
• Study Start: 2021-06-24
• Study First Posted: 2021-06-25
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28
• Primary Completion: 2022-06-24
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 540

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anal incontinence	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 Outcome Measures

Name	Time	Method
Incidence of anal incontinence	Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)	AI graded by the St Mark Score
Quality of life with fecal incontinence quality of life score	the date of the survey (2 to 16 years after childbirth)	fecal incontinence quality of life score
Expectation of the women in term of information	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
cinetic of AI occurence	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