Using a short questionnaire to identify who sticks with transanal irrigation (TAI)
Official title: Adherence Assessment in Transanal Irrigation : Validation of the Transanal Irrigation Adherence Scale
Run by Assistance Publique - Hôpitaux de Paris · NCT06805903 · Data updated 2026-11-12
This project tests a short French questionnaire to see if it can identify adults using transanal irrigation who stick with the treatment and those who stop.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | March 30, 2026 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2028 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT06805903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who have been using transanal irrigation for at least one month for constipation or fecal incontinence, who can read French and provide informed consent.
✕Probably not a fit
People who do not use TAI, cannot read or understand French, are under legal protection, or have significant cognitive or language barriers are unlikely to benefit from this questionnaire validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will perform psychometric validation of the TRIAL self-questionnaire, a French tool designed to measure adherence to transanal irrigation (TAI). Adult patients who have used TAI for at least one month for constipation or fecal incontinence will complete the questionnaire alongside collection of clinical and demographic information. Analyses will examine reliability and validity of the scale and compare questionnaire scores with reported TAI use to identify non-adherent patients. The information will be used to clarify reasons for stopping TAI and guide interventions to improve long-term use.
Why it matters
Potential benefit: If successful, clinicians could identify patients who are not following TAI sooner and offer targeted support to improve bowel control and quality of life.
How similar studies have gone: Transanal irrigation has demonstrated clinical benefit in many neurological and non-neurological populations, but validated adherence questionnaires are limited, making this psychometric validation relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière
Paris, France Recruiting
Study contacts
- Study coordinator: Maëlys TENG, MD, MSc
- Email: maelys.teng@aphp.fr
- Phone: 0033 1 42 16 36 74
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.