Randomised controlled trial of Early biofeedBAck PhysioTherapy versus pelvic floor exercises in patients who sustain third degree tears

ISRCTN	ISRCTN70419152
DOI	https://doi.org/10.1186/ISRCTN70419152
Secondary identifying numbers	2

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Colm O Herlihy
Scientific

UCD School of Medicine and Medical Science
National Maternity Hospital
Dublin
2
Ireland

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	EBAPT
Study objectives	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(s)	Approval received from the National Maternity Hospital on the 21st January 2007
Health condition(s) or problem(s) studied	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
Primary outcome measure	Manometry scores at three months.
Secondary outcome measures	Symptoms and continence scores at three months.
Overall study start date	01/02/2007
Completion date	31/01/2008

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	80
Key inclusion criteria	Patients who have sustained a third degree tear in labour
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	31/01/2008

UCD School of Medicine and Medical Science

Dublin
2
Ireland

National Maternity Hospital (Ireland)
Hospital/treatment centre

Holles Street
Dublin
2
Ireland

Website	http://www.nmh.ie/Internet/
"ROR"	https://ror.org/03jcxa214

Government

National Maternity Hospital, Health Research Board of Ireland (Ireland)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan