Anal Incontinence After Obstetrical Anal Sphincter Injury

Anal Incontinence Clinical Trial

— INCONT-LOSA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04940494
• Other study ID #: 2021-A01128-33
• Status: Not yet recruiting
• Start date: June 24, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2021
• Source: University Hospital, Angers
• Contact: Aurélien VENARA, M.D.
• Phone: 0241353618
• Email: auvenara[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anal Incontinence
• Anal Sphincter Injury
• Fecal Incontinence
• Obstetric Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

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)