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

NCT06143072 | Recruiting

• 1 other identifier: 333989
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstetric Anal Sphincter Injury; Severe Perineal Trauma; Grade 3 Perineal Tear; Grade 4 Perineal Tear; Anal Incontinence; Faecal Incontinence; Urgency; Deferral Time; Pathways; Follow-up; Review; Endo-anal Ultrasound; Urogynaecology; Biofeedback

Outcome Measures

Primary Outcomes (8)

• 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)

  12 months

• 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)

  12 months

• 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)

  12 months

• 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)

  12 months

• The Obstetrics and Urogynaecologists perception of the quality of care the patient has 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 as conducted by the team (part 2 of study)

  12 months

• The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care

  considering how these patients are assessed (part 2 of study)

  12 months

• The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care

  considering the length of time taken to follow up a patient (whether symptomatic or asymptomatic) (part 2 of study)

  12 months

• The Obstetrics and Urogynaecologists perception of the quality of care the patient has received following OASI-associated incontinence, as a measure of follow up care

  considering if there is a policy/pathway in place for the management of OASI-associated incontinence (part 2 of study)

  12 months

Secondary Outcomes (5)

• 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.

  12 months

• 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

  12 months

• 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

  12 months

• 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

  12 months

• 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

  12 months

Study Arms (2)

Part 1 of study

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 of study

Obstetricians (consultants) and urogynaecologists who are involved in and/or oversee the care of OASI patients' post-partum in the UK.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Primiparous/multi-parous

You may not qualify if:

• 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).
• Women with an OASI who have been referred directly from the maternity unit at the same trust as the specialist perineal clinic, where an existing trust policy exists for direct referral of these patients from the maternity unit to the perineal clinic.
• Part 2 of study:
• urogynaecologists/obstetricians who oversee the care of or look after patients with OASI and who are practising in UK NHS hospitals at the time of completion of the survey. They must be on the GMC specialist register to be eligible to participate
• trainees, obstetricians/gynaecologists not routinely involved in the care of OASI patients.

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London Northwest Healthcare NHS Trust

London, NW10 7NS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 22, 2023
• Study Start: January 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)