CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
Recruiting now
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT06143072
- Run by
- London North West Healthcare NHS Trust
- People needed
- 112
- Starts
- 2024-01-01
- Expected to finish
- 2025-07-01
- Last updated by the study team
- 2025-05-25
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
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:
- Inclusion criteria:
- 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
- Exclusion criteria:
- trainees, obstetricians/gynaecologists not routinely involved in the care of OASI patients.
Where it is running
- London Northwest Healthcare NHS Trust — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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