Condition: Irritation; Anus · Sponsor: Assistance Publique - Hôpitaux de Paris
Transanal irrigation (TAI) is a method used to empty stools from the recto-sigmoid and colon (from the descending colon to the transverse colon). It is recommended for treating evacuation disorders (bowel movements) or continence issues (fecal incontinence). It is a second-line treatment, offered after the failure of hygienic-dietary rules, perineal physiotherapy, and conventional drug treatments (suppositories, obturator plugs, etc.), in combination with treatments for transit constipation (hygienic-dietary rules and laxatives) if necessary. The effectiveness of TAI has been widely demonstrated, particularly in neurological populations (spinal cord injuries, spina bifida, multiple sclerosis, etc.), but also in non-neurological populations, with a significant reduction in symptoms (constipation or incontinence) and an improvement in quality of life compared to medical treatment Despite demonstrated effectiveness with a long-term success rate of 50% among users, only 42% of patients continue use 21 months after learning the technique. The aim of this study is to validate a tool for assessing patient adherence to the TAI device in order to identify non-adherent patients and subsequently determine the reasons for non-adherence to optimize treatment, in the absence of non-surgical therapeutic alternatives The primary objective of this study is the psychometric validation of a transanal irrigation adherence self-questionnaire scale (TRIAL) in French. The secondary objectives ar…
This description comes directly from the study's public registry record.
Maëlys TENG, MD, MSc · 0033 1 42 16 36 74 · maelys.teng@aphp.fr
Gerard AMARENCO, MD, PhD · 0033 1 42 16 36 75 · gerard.amarenco@aphp.fr
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| Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06805903