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Search / Trial NCT06143072

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

Launched by LONDON NORTH WEST HEALTHCARE NHS TRUST · Nov 20, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The CArE for OAsI Study is focused on understanding how patients with a specific type of injury from childbirth, known as obstetric anal sphincter injury (OASI), are currently followed up and cared for. These injuries can lead to issues like anal and fecal incontinence, which means having difficulty controlling bowel movements. The study aims to identify the care pathways in place for these patients, as many might not speak up about their symptoms. By improving these pathways, the goal is to ensure that women receive the necessary support and care, ultimately reducing legal claims related to these injuries.

To participate in this study, women aged 18 to 50 who have experienced incontinence due to OASI within the last five years can join. Participants will be asked to share their experiences and may undergo evaluations to better understand their condition. Additionally, healthcare professionals involved in the care of these patients may also be included in the study to provide feedback. This research is important not only for improving patient care but also for reducing the financial strain on the National Health Service related to litigation.

Gender

FEMALE

Eligibility criteria

  • Part 1 of Study
  • Inclusion Criteria:
  • • 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
  • Exclusion Criteria:
  • • 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.

About London North West Healthcare Nhs Trust

London North West Healthcare NHS Trust is a leading healthcare provider in the UK, dedicated to delivering high-quality patient care across a diverse range of medical services. With a commitment to innovation and research, the Trust actively engages in clinical trials to advance medical knowledge and improve treatment outcomes. It operates several hospitals and community services, serving a large and diverse population in North West London. By fostering collaboration between healthcare professionals and researchers, London North West Healthcare NHS Trust aims to enhance patient care through evidence-based practices and the integration of cutting-edge medical research into clinical settings.

Locations

London, , United Kingdom

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported