Care pathways for women with obstetric anal sphincter injury-related incontinence
Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery
This study looks at how women with incontinence from childbirth-related injuries are currently cared for to see if better support can be provided.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | London North West Healthcare NHS Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT06143072 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify existing care pathways for women suffering from incontinence due to obstetric anal sphincter injuries (OASI) following vaginal delivery. It focuses on understanding how these patients are currently followed up and cared for, as many may not openly discuss their symptoms. The study highlights the importance of robust care pathways to ensure adequate support and management of these injuries, which can lead to significant physical and psychological complications. By improving care, the study also seeks to address the financial burden of litigation associated with inadequate management of such injuries.
Who should consider this trial
Good fit: Ideal candidates are fertile women aged 18 to 50 who have experienced OASI-related incontinence after vaginal delivery within the last five years.
Not a fit: Patients who do not speak, read, or understand English, or those with non-obstetric causes of incontinence, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved care and support for women suffering from OASI-related incontinence, enhancing their quality of life.
How similar studies have performed: While this study addresses a significant issue, similar studies focusing on care pathways for obstetric injuries have shown varying degrees of success, indicating a need for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London
- London Northwest Healthcare NHS Trust — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.