Condition category
Pregnancy and Childbirth
Date applied
23/01/2007
Date assigned
03/05/2007
Last edited
30/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colm O Herlihy

ORCID ID

Contact details

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

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

http://www.nmh.ie/Internet/

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

Publication citations

Additional files

Editorial Notes