Using a short questionnaire to identify who sticks with transanal irrigation (TAI)
Adherence Assessment in Transanal Irrigation : Validation of the Transanal Irrigation Adherence Scale
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06805903 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.