CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorLondon North West Healthcare NHS Trust

About this trial

The aim of this study is to ascertain which pathways currently exist in relation to the follow up of patients with obstetric anal sphincter injury related incontinence. This is particularly important as afflicted individuals may not readily volunteer information about their symptoms and struggles and need to be safeguarded by the presence of robust care pathways that ensure adequate follow up and care provision.

As obstetric anal sphincter injuries have been associated with increased litigation rates over the years, positive interventions towards patient care will help ameliorate the financial burden that litigation carries on the National Health Service. It is noteworthy of mention that perineal injury, in itself, may not be suggestive of negligent care and is a recognized complication of vaginal delivery. However, a failure to adequately manage the injury may carry medicolegal implications.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• Fertile women ≥ 18 years and ≤50 who have developed OASI related incontinence following a vaginal delivery in the preceding five years (N.B. the average age of menopause in the UK is 51)

Tertiary referrals to the specialist perineal clinic as well as patients who have 'slipped' through the existing pathway of referral

Capacity to consent (able to comprehend and retain information, weight out the risks and benefits and communicate a decision back to the researcher)

English-speaking and able to comprehend and read English

Disqualifiers

• Women who are unable to consent or who have severe mental illness, as decided by the screening clinician

Patients who do not speak, read or understand English

Patients with an alternative documented cause for their FI that is non obstetric trauma related.

Post-menopausal women who may develop late onset symptoms of incontinence relating to a previous OASI (clinically silent injuries that manifest in later life secondary to hormonal influences or advancing age for example).

Trial population

There are two parts to study: Part 1: semi-structured interview, retrospective study, mix of qualitative and quantitative methods - involving patients. Women who have sustained an obstetric-related anal sphincter injury (grade 3 and 4 perineal tears) AND who are symptomatic of anal/faecal incontinence within the first five years following a vaginal delivery are eligible to participate, provided they have capacity to consent. Part 2: Cross-sectional, observational study with a mix of qualitative and quantitative analysis, using a survey, to be completed by urogynaecologists/obstetricians Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK.

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

112 Participants
are grouped into 2 trial groups
Group A: Part 1 of study
Group B: Part 2 of study

Trial outcomes

Primary outcomes

1

The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care

considering whether the patient was assessed clinically for incontinence during the post-partum check at 6-12 weeks conducted by the obstetrics/urogynaecology team (part 1 of study)

Time frame
12 months
2

The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care

considering the ease with which they were able to discuss the symptoms of incontinence with a clinician (part 1 of study)

Time frame
12 months
3

The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care

considering how symptoms were managed before consulting a clinician and after (part 1 of study)

Time frame
12 months
4

The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care

considering who they saw during their follow up appointments and when (including referrals), and what was discussed and what action was taken for the management of their incontinence (including counselling regarding future pregnancies) (part 1 of study)

Time frame
12 months

Secondary outcomes

1

Degree of OASI in relation to symptoms and Quality of Life, evaluated using a patient's own verbatim account of their lived experience and assessed via open ended questions in a semi-structured interview.

The influence of severity of OASI on incontinence, and the latter's effect on the patient's quality of life (including effect on job, family and relationships) (part 1 of study)

Time frame
12 months
2

The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT

considering: whether or not these patients are discussed in the MDT (part 2 of study)

Time frame
12 months
3

The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT

considering whether or not these patients are reviewed by a physiotherapist and if so, at what stage post-partum? (part 2 of study)

Time frame
12 months
4

The Obstetrics and Urogynaecologists perception of the quality of care received following OASI-associated incontinence, as a measure of being seen/reviewed by other members of the MDT

considering: If they are referred for anorectal studies (part 2 of study)

Time frame
12 months

Other outcomes

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