Fecal IncontinenceEPICNCT00632567
EPIC :Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
A study testing caesarean section and vaginal delivery in people with Fecal Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- caesarean section and vaginal delivery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2008to Apr 2016
- Phase
- Interventional
- 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
Who may be able to join
- More than 18 years old
- Having health insurance
- Second pregnancy
- First delivery was traumatic
- No anal incontinence
- Accept to participate, sign the informed consent
- Prior medical examination
Who cannot join
- Monitoring impossible
- Woman who have an anal operation
- Caesarean section
- First delivery with anal break stage 4
- Indication of a scheduled caesarean section not for proctologic reason
- Patient physically, mentally or legally incompetent to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.
Read the detailed description
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.
So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective. It seems to be very useful to compare, in randomized controlled study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).
The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. The investigators estimated, needing 123 women in each arm.
Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
- Conditions
- Fecal Incontinence
- Being tested
- caesarean section, vaginal delivery
- Keywords
- Anal incontinence, First delivery was traumatic, No anal incontinence
- Medical subject headings
- Fecal Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caesarean sectionProcedure or surgery
caesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
vaginal deliveryProcedure or surgery
vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | caesarean section Receives: Procedure: caesarean section |
| 2 | Active comparator | vaginal delivery Receives: Procedure: vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.
Measured: 6 months
Secondary outcomes (1)
Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy
Measured: 6 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent ABRAMOWITZ, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632567
- Sponsor's protocol ID
- P060246
- Acronym
- EPIC
- Status last verified
- Dec 2016
- First submitted
- 28 Feb 2008
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Incontinence After Delivery. Secondary Prevention With Caesarean Section.
- ClinicalTrials.gov ID
- NCT00632567
- Acronym / sponsor ID
- EPIC / P060246
- Conditions
- Fecal Incontinence
- Keywords
- Anal incontinence, First delivery was traumatic, No anal incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 10 Mar 2008 (estimated)
- 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.
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section. So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective.
Detailed description
Anal incontinence is frequent and treatment is difficult. One of the most important reasons is traumatic delivery. 10 % of women develop anal incontinence after first delivery. This incidence is higher after second vaginal delivery, particularly if the first delivery caused break in the anal sphincter. One possibility to avoid anal incontinence is the caesarean section.
So, do the investigators have to recommend caesarean section for second delivery if the first was traumatic? But caesarean section had a morbidity. Actually, the choice between the delivery modalities is very subjective. It seems to be very useful to compare, in randomized controlled study, global morbidity of caesarean section and vaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. In start of study, all women were included, for randomisation ("section cesarean prophylactic" versus "vaginal delivery") if an anal sphincter rupture is diagnosed with anal endosonography before second delivery. . Currently, in case of refusal randomisation, women are proposed to participate to the ancillary study (cohort study).
The primary endpoint is comparison of median incontinence score of VAISEY in the two arms after 6 months. The secondary endpoints are urinary incontinence, quality of life and global morbidity between the two arms after second delivery. The investigators estimated, needing 123 women in each arm.
Hospital investigators are: BICHAT Claude Bernard (Pr LUTON), Armand Trousseau (Pr BENIFLA), Jean VERDIER (Pr CARBILLON), BEAUJON (Pr LUTON), Louis MOURIER (Pr MANDELBROT), Versailles (Dr PANEL). Inclusion will be for 6 years and 9 months. Women will be included during the last trimester and evaluation will be perform on 8 weeks, 6 and 12 month after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: caesarean sectioncaesarean section |
| 2 | Active comparator | Procedure: vaginal deliveryvaginal delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- More than 18 years old
- Having health insurance
- Second pregnancy
- First delivery was traumatic
- No anal incontinence
Key exclusion criteria (6 listed)
- Monitoring impossible
- Woman who have an anal operation
- Caesarean section
- First delivery with anal break stage 4
- Indication of a scheduled caesarean section not for proctologic reason
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 |
|---|---|---|
| caesarean sectioncaesarean section for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. | Procedure or surgery | 1 |
| vaginal deliveryvaginal delivery for second delivery if the first had to be traumatic after forceps with anal sphincter rupture diagnosed with anal endosonography. | Procedure or surgery | 2 |
Primary outcome
The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months.
Time frame: 6 months
1 secondary outcome
Incontinence scores in the two arms after 6/8 weeks and 6 month, transitional anal incontinence after delivery urinary incontinence 6 and 12 month after the delivery, sexual score(IFSI)global morbidity between the two arms after anal endoscopy
Time frame: 6 month and 12 month
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 15 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Laurent ABRAMOWITZ, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caesarean section and vaginal delivery in people with Fecal Incontinence, run by Assistance Publique - Hôpitaux de Paris 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 7 inclusion and 6 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 15 Dec 2016. 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?
The primary endpoint is comparison of median incontinence score of VAIZEY in the two arms after 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2016.