Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2
Study information
Scientific title
Acronym
EBAPT
Study hypothesis
Women who sustain third or fourth degree tears are at risk of subsequent faecal incontinence. Our hypothesis is that women who sustain a third degree tear who have early intervention with home biofeedback physiotherapy will have fewer symptoms and better manometry pressures than those advised to perform standard pelvic floor exercises.
Ethics approval
Approval received from the National Maternity Hospital on the 21st January 2007
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anal sphincter injury leading to anal incontinence
Intervention
We propose to randomise patients who have sustained a third or fourth degree tear into two groups. One group receives current management of laxatives, antibiotics and analgesia and is advised on pelvic floor exercises. The other group is shown how to perform biofeedback exercises using a machine at home. Both groups will be followed up at the specialised perineal clinic and will be evaluated using endo-anal ultrasound and anorectal manometry.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Manometry scores at three months.
Secondary outcome measures
Symptoms and continence scores at three months.
Overall trial start date
01/02/2007
Overall trial end date
31/01/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Patients who have sustained a third degree tear in labour
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Patients who sustained a third degree tear in a previous delivery
2. Patients whose babies are in the special care baby unit
3. Infectious blood borne disease: Human Immunodeficiency Virus (HIV) and hepatitis B and C
4. Patients who have drug and alcohol addiction problems and would not be likely to be able to follow the home programme
5. Patients who do not have a fluent command of English
Recruitment start date
01/02/2007
Recruitment end date
31/01/2008
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD School of Medicine and Medical Science
Dublin
2
Ireland
Sponsor information
Organisation
National Maternity Hospital (Ireland)
Sponsor details
Holles Street
Dublin
2
Ireland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Maternity Hospital, Health Research Board of Ireland (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary