Referral Pathways and Care Provision for Patients Who Develop OASI Associated Incontinence in the First Five Years Following a Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
研究概览
简要总结
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.
详细描述
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 affecting up to 80% of women. Perineal injury is classified into four categories, as per the Sultan classification:
Grade 1: involvement of perineal skin +/- vaginal mucosa Grade 2: involvement of perineal muscles Grade 3a: <50% External Anal Sphincter (EAS) Grade 3b: >50% EAS Grade 3c: EAS + Internal Anal Sphincter (IAS) Grade 4: Grade 3c + anorectal mucosa The latter two categories are associated with considerable morbidity and are known as obstetric anal sphincter injuries (OASIS). OASIS encompass grade 3 and 4 perineal tears and effect the integrity of the anorectal sphincter complex, with or without involvement of the anorectal mucosa.
Such injuries may be associated with a myriad of devastating and stigmatizing sequelae, including faecal and urinary incontinence, dyspareunia, rectovaginal fistulae, perineal pain and pelvic organ prolapse, which in turn may have a negative impact on a woman's quality of life and day-to-day living. Indeed, sustaining an Obstetric Anal Sphincter Injury (OASI) has been associated with both physical and psychological sequelae.
Symptoms of urgency and urge faecal incontinence, are suggestive of damage to the external anal sphincter, while symptoms of passive leakage are indicative of damage to the internal anal sphincter. Not all women with OASIS are symptomatic. Symptomatic OASIS occurs in about 30-50% of women. It is important to note that the real incidence may be higher as it may very well be underreported.
The incidence of OASIS in the UK is 2.9%. Although OASIS is uncommon, the rate of OASIS in singleton, cephalic and first vaginal deliveries, has reportedly tripled from 1.8% to 5.9% from 2000 to 2012. This may, however, be secondary to better detection of these injuries following improvements in education, training and the utilization of a standardized classification system for perineal tears. To address the rising OASI rates, the OASI care bundle was introduced which primarily focused on interventions in the antenatal period to reduce the incidence of OASIS. Prevention of OASIS, however, will not always be possible, even with the best efforts of care. Therefore, focus should also be placed on the optimal management of these patients' post-partum.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• 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
排除标准
- •• 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.
结局指标
主要结局
The patient's perception of the quality of care received following OASI-associated incontinence, as a measure of follow up care
时间窗: 12 months
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)
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
时间窗: 12 months
considering if there is a policy/pathway in place for the management of OASI-associated incontinence (part 2 of study)
次要结局
- 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)