Anal Incontinence Clinical Trial
— INCONT-LOSAOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 540 |
Est. completion date | July 1, 2022 |
Est. primary completion date | June 24, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of anal incontinence | AI graded by the St Mark Score | Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth) | |
Secondary | cinetic of AI occurence | 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) | |
Secondary | Quality of life with fecal incontinence quality of life score | fecal incontinence quality of life score | the date of the survey (2 to 16 years after childbirth) | |
Secondary | Expectation of the women in term of information | 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) |
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