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Clinical Trials in France / NCT06805903
Recruiting Observational

Validation of TRansanal Irrigation Adherence scaLe (TRIAL)

NCT06805903 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-03-30
Last updated
2026-04-06

Condition(s) studied

Irritation; Anus

Investigational drug(s) / intervention(s)

TRansanal Irrigation Adherence scaLe

TRansanal Irrigation Adherence scaLe: new trans-anal irrigation self-assessment questionnaire in French

Study summary

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 are assessing : 1/ correlation between the final score of TRIAL with sides effects reported, the using modalities, indications of this treatment, and patient's satisfaction. 2/ quality of life of these patients using the Transanal irrigation device. 3/ correlation between the final score of TRIAL and stool diary in order to define the cut-offs of strong, moderate and low adherence of this scale.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria * Patients using ICT for at least 1 month * Patients with anorectal disorders of neurological or neurological or non-neurological origin * Patients whose indication for TCI is constipation, anorectal and/or fecal incontinence. * Adult patients * Informed patients who do not object to participating in the study. Exclusion criteria * Language barrier and comprehension difficulties * Patients under legal protection

Primary outcome measure(s)

  • Psychometric validation of a transanal irrigation adherence self-questionnaire scale, in French — 30 months and 15 days

Trial sites (1)

FacilityCityRegionStatus
Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière Paris France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805903 on ClinicalTrials.gov ↗ ← All trials in France