Status:
RECRUITING
CArE for OAsI Study: Care Pathways and Anorectal Evaluation for OASI Associated Incontinence
Lead Sponsor:
London North West Healthcare NHS Trust
Conditions:
Obstetric Anal Sphincter Injury
Severe Perineal Trauma
Eligibility:
FEMALE
18-50 years
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 ...
Detailed Description
Historically, pregnancy and childbirth has been erroneously considered to be an innocuous physiological event. However, vaginal delivery may be associated with perineal injury, a common occurrence aff...
Eligibility Criteria
Inclusion
- Part 1 of Study
- • 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
- • 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06143072
Start Date
January 1 2024
End Date
July 1 2025
Last Update
May 25 2025
Active Locations (1)
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1
London Northwest Healthcare NHS Trust
London, United Kingdom, NW10 7NS