Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence

Официальное название

Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and/or Faecal Incontinence, a Real-world Randomised Explorative Investigation.

Обзор

This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA/CE-marked transanal irrigation products for the management of faecal incontinence and/or chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits/phone calls as the only difference from typical clinical procedure. During 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.

Вмешательства

• Устройство Transanal irrigation
  Transanal irrigation by use of irrigation devices

Первичные конечные точки

• Bowel Irrigation Questionnaire (BIQ) 4-point ordinal scale [Срок оценки: Week 4, 10, 26, and 52]

Вторичные конечные точки (5)

• Patient Diary [Срок оценки: Week 10, 26, and 52]
• Patient Diary [Срок оценки: Week 10, 26, and 52]
• Cleveland Clinic Constipation Score (CCCS) [Срок оценки: Week 0, 4, 10, 26, and 52]
• St Mark's Incontinence Score (SMIS [Срок оценки: Week 0, 4, 10, 26, and 52]
• The 5-level EQ-5D (EQ-5D-5L) index score [Срок оценки: Week 0, 4, 10, 26, and 52]

Критерии участия

Критерии включения

• Faecal incontinence (FI), chronic constipation (CC) or co-existing FI/CC, all of heterogenous origin
• Positive Rome IV criteria for functional constipation and/or positive Rome IV criteria for faecal incontinence
• 18 years or older
• Ability to understand written and spoken English (due to questionnaire validity)
• Ability to understand and provide written, informed consent prior to any investigation-specific procedures

Критерии исключения

• Prior use of transanal irrigation
• Neurogenic bowel dysfunction
• Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).
• Previous rectal and/or anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal/rectal abscess, or other rectal or anal surgeries deemed minor by the investigator)
• Physical disability that affects the ability to independently use the irrigation device
• Intermittent use of opioids inducing chronic constipation
• Patulous anus
• Participation in research conflicting with the current investigation
• Physical or mental conditions affecting the ability to comply with the clinical investigation plan
• Pregnancy or plans to become pregnant during the investigation period

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07473622 · QF008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗