Obstetric TraumaINCONT-LOSANCT04940494
Anal Incontinence After Obstetrical Anal Sphincter Injury
An observational study of Obstetric Trauma and Anal Sphincter Injury, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Obstetric Trauma, Anal Sphincter Injury, Anal Incontinence
- What is being tested?
- collection of data
- How many people
- 227 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 6 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women that gave birth between 2005 January 1st and 2019 December 31th and that accept to respond to the survey
Who may be able to join
- Childbirth between 2005 January 1st and 2019 December 31th
- Obstetrical Anal Sphincter Injury -≥ 18 y
Who cannot join
- Patients' refusal
- lost of view or deceased
- anal incontinence before the Obstetrical Anal Sphincter Injury
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Obstetric Trauma, Anal Sphincter Injury, Anal Incontinence
- Being tested
- collection of data
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of dataOther
collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)
What is being measured
The primary outcome is the main question the study is designed to answer.
anal incontinence
loss of stool or gas ≥1/week during ≥1 month
Measured: from the childbirth to the day of survey (2 to 16 years after childbirth)
Secondary outcomes (4)
Incidence of anal incontinence
AI graded by the St Mark Score
Measured: Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)
cinetic of AI occurence
all the resolutive episodes of occurence of anal incontinence are reported
Measured: 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
fecal incontinence quality of life score
Measured: the date of the survey (2 to 16 years after childbirth)
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
Measured: the date of the survey (2 to 16 years after childbirth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jul 2021
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetric TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aurélien VENARA, M.D., Principal investigator, University Hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940494
- Sponsor's protocol ID
- 2021-A01128-33
- Acronym
- INCONT-LOSA
- Status last verified
- Sep 2025
- First submitted
- 17 Jun 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38368278
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors for Anal Incontinence After Obstetrical Anal Sphincter Injury
- ClinicalTrials.gov ID
- NCT04940494
- Acronym / sponsor ID
- INCONT-LOSA / 2021-A01128-33
- Conditions
- Obstetric Trauma, Anal Sphincter Injury, Anal Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women that gave birth between 2005 January 1st and 2019 December 31th and that accept to respond to the survey
Key inclusion criteria (2 listed)
- Childbirth between 2005 January 1st and 2019 December 31th
- Obstetrical Anal Sphincter Injury -≥ 18 y
Key exclusion criteria (3 listed)
- Patients' refusal
- lost of view or deceased
- anal incontinence before the Obstetrical Anal Sphincter Injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of datacollection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...) | Other | – |
Primary outcome
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
4 secondary outcomes
Incidence of anal incontinence
Time frame: Incidence of anal incontinence the date of the survey (2 to 16 years after childbirth)
cinetic of AI occurence
Time frame: 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
Time frame: the date of the survey (2 to 16 years after childbirth)
Expectation of the women in term of information
Time frame: the date of the survey (2 to 16 years after childbirth)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 38368278Rebmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélien VENARA, M.D. principal investigator
University Hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Trauma and Anal Sphincter Injury, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anal incontinence (time frame: from the childbirth to the day of survey (2 to 16 years after childbirth)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940494, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.