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Randomised controlled trial of Early biofeedBAck PhysioTherapy versus pelvic floor exercises in patients who sustain third degree tears
ISRCTN ISRCTN70419152
DOI 10.1186/ISRCTN70419152
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial of Early biofeedBAck PhysioTherapy versus pelvic floor exercises in patients who sustain third degree tears
Scientific title
Acronym EBAPT
Serial number at source 2
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.
Lay summary Not provided at time of registration
Ethics approval Approval received from the National Maternity Hospital on the 21st January 2007
Study design Randomised controlled trial
Countries of recruitment Ireland
Disease/condition/study domain Anal sphincter injury leading to anal incontinence
Participants - inclusion criteria Patients who have sustained a third degree tear in labour
Participants - 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
Anticipated start date 01/02/2007
Anticipated end date 31/01/2008
Status of trial Completed
Patient information material
Target number of participants 80
Interventions 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.
Primary outcome measure(s) Manometry scores at three months.
Secondary outcome measure(s) Symptoms and continence scores at three months.
Sources of funding National Maternity Hospital, Health Research Board of Ireland (Ireland)
Trial website
Publications
Contact name Prof  Colm  O Herlihy
  Address UCD School of Medicine and Medical Science
National Maternity Hospital
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
Sponsor National Maternity Hospital (Ireland)
  Address Holles Street
  City/town Dublin
  Zip/Postcode 2
  Country Ireland
  Sponsor website: http://www.nmh.ie/Internet/
Date applied 23/01/2007
Last edited 30/08/2011
Date ISRCTN assigned 03/05/2007
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