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Clinical Trials/NCT04940494
NCT04940494
Completed
Not Applicable

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

University Hospital, Angers1 site in 1 country227 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetric Trauma
Sponsor
University Hospital, Angers
Enrollment
227
Locations
1
Primary Endpoint
anal incontinence
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
July 6, 2022
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Incidence of anal incontinence(Incidence of anal incontinence 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))
  • cinetic of AI occurence(from the childbirth to the date of the survey (2 to 16 years after childbirth))

Study Sites (1)

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