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 |
- Submission date
- 23/01/2007
- Registration date
- 03/05/2007
- Last edited
- 30/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Colm O Herlihy
Scientific
Scientific
UCD School of Medicine and Medical Science
National Maternity Hospital
Dublin
2
Ireland
Study information
| 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 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(s) | Approval received from the National Maternity Hospital on the 21st January 2007 |
| 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 |
| 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 |
| Overall study end date | 31/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Participant inclusion criteria | Patients who have sustained a third degree tear in labour |
| 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
Study participating centre
UCD School of Medicine and Medical Science
Dublin
2
Ireland
2
Ireland
Sponsor information
National Maternity Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Holles Street
Dublin
2
Ireland
| Website | http://www.nmh.ie/Internet/ |
|---|---|
"ROR" |
https://ror.org/03jcxa214 |
Funders
Funder type
Government
National Maternity Hospital, Health Research Board of Ireland (Ireland)
No information available
Results and Publications
| 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 |
