Randomised controlled trial comparing early home biofeedback physiotherapy with pelvic floor exercises for the treatment of third degree tears (EBAPT trial) C Peirce, C Murphy, M Fitzpatrick, M Cassidy, L Daly, PR O’Connell, C O’Herlihy

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Background Third degree tears associated with increased risk of subsequent faecal incontinence Optimum management and follow up of third degree tears remains unknown

The Clinical Question Does early home biofeedback physiotherapy with pelvic floor exercises lead to improved manometry readings and quality of life scores after obstetrics anal sphincter injury?

Structured Question ParticipantsPrimiparous women who sustained primary third degree tears during childbirth InterventionEarly biofeedback physiotherapy (using a portable biofeedback machine) ComparisonPelvic floor exercise education OutcomesPrimary: differences in anorectal manometry at 3 months post-partum Secondary: Cleveland clinic continence scores and Rockwood faecal incontinence qualify of life scale scores Study DesignRandomised controlled trial

Flow chart of the study ELIGIBILITY n=145 ALLOCATED (Biofeedback, n=30) ALLOCATED (PFEs, n=90) EXCLUDED n=25 ADHERENCE Yes, n=23; No, n=7 ADHERENCE Yes, n=90 ANALYSIS n=30 ANALYSIS n=90 RANDOMISED n=120

Background What are the long-term outcomes of women who sustained obstetrics anal sphincter injuries (see suggested reading)? Is anal continence at three months postpartum reflective of long-term continence? How does your local hospital assess symptoms of complications (e.g. incontinence) after obstetric anal sphincter injuries?

Methods What are the differences between internal validity and external validity of a clinical trial? How does the lack of blinding in this trial affect its validity? Are there alternative methods to address this issue?

Statistics Do you agree with the method of power calculation used in this study (see suggested reading)?

Manometry

Quality of Life LifestyleCoping DepressionEmbarrassment

Results What are the implications of poor adherence observed in this study?

Authors’ summary No added value of early biofeedback physiotherapy Compliance an issue: time, asymptomatic Biofeedback for symptomatic women at standard 3 month follow up

Take home message In a single sentence, how would you describe the available evidence on early biofeedback physiotherapy in the prevention of complications after obstetric anal sphincter injuries?

Suggested Reading Fornell EU, Matthiesen L, Sjödahl R, Berg G. Obstetric anal sphincter injury ten years after: subjective and objective long term effects. BJOG Mar;112(3): PubMed PMID: Bland JM. The tyranny of power: is there a better way to calculate sample size? BMJ Oct 6;339:b3985. doi: /bmj.b3985. PubMed PMID: