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Идёт набор NCT07062731

Pelvic Floor Exercises for Suboptimal Anorectal Manometry

— Наблюдательное Obstetric Anal Sphincter Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Supervised pelvic floor muscle exercises.
Кому может быть актуально
Состояния в реестре: Obstetric Anal Sphincter Injury. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Официальное название

Effect of Pelvic Floor Muscle Exercises on Women With Suboptimal Anorectal Manometry Results After an Obstetric Anal Sphincter Injury (OASI)

Обзор

Currently, guidelines from the Royal College of Obstetricians and Gynaecologists stipulate that all women who have sustained an obstetric anal sphincter injury in a previous pregnancy and who are symptomatic or have abnormal endoanal ultrasonography and/ or manometry should be counselled regarding the option of an elective Caesarean section. An abnormal endoanal ultrasonography is currently considered to be a defect of the external anal sphincter (EAS) of more than 30 degrees while an abnormal anorectal manometry would be an incremental squeeze pressure of less than 20mmHg. This study aims to evaluate if a course of guided pelvic floor exercises could improve anal sphincter function on those with suboptimal or abnormal anal incremental squeeze pressures, and subsequently expand their options for future modes of delivery (vaginal delivery not contraindicated)

Вмешательства

  • Поведенческое Supervised pelvic floor muscle exercises
    4 months of supervised physiotherapy by a women's health physiotherapists (3 sessions in total)

Первичные конечные точки

  • Success [Срок оценки: 4 months]
Вторичные конечные точки (4)
  • Change or recommended mode of delivery [Срок оценки: 4 months]
  • Change in St Mark's Score [Срок оценки: 4 months]
  • Change in International Consultation on Incontinence Questionnaire- Urinary Incontinence Short Form (ICIQ-UI SF) [Срок оценки: 4 months]
  • Change in Faecal Incontinence Quality of life Scale [Срок оценки: 4 months]

Критерии участия

Критерии включения

  • Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
  • Are at least 6 weeks postpartum
  • Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum
  • Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.
  • Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
  • Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.

Критерии исключения

  • Inclusion Criteria
  • Female patients who have sustained an obstetric anal sphincter injury after their most recent delivery and:
  • Are at least 6 weeks postpartum
  • Has not received any form of guided pelvic floor exercises by a licensed women's health physiotherapist postpartum
  • Either able to speak, read and write in English, or has a professional interpreter present at the time of appointment.
  • Capable of understanding and signing the informed consent form after full discussion of the investigations and its risks and benefits.
  • Able and willing to complete the St Mark's Score, ICIQ-UI SF and other trial related questionnaires, comply with scheduled clinic visits and manometry studies.

Критерии исключения

  • Women who have sustained an obstetric anal sphincter injury more than a year ago
  • Women who have had another vaginal delivery after sustaining an obstetric anal sphincter injury in a previous delivery.
  • Existing anal pain precluding anorectal examination
  • Existing neurological, musculoskeletal disorders which impedes ability to perform pelvic floor muscle exercises
  • Age <18 years old
  • Currently pregnant
  • Inability to comply with pelvic floor muscle exercises

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Kings College Hospital — London

Идентификаторы

NCT: NCT07062731 · IRAS 353671

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗