Actively Recruiting
Validation of TRansanal Irrigation Adherence scaLe (TRIAL)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-06
100
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validation of TRansanal Irrigation Adherence scaLe (TRIAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients using transanal irrigation for at least 1 month
- Patients with anorectal disorders of neurological or non-neurological origin
- Patients whose indication for transanal irrigation is constipation, anorectal disorder, and/or fecal incontinence
- Adult patients aged 18 years or older
- Patients who agree to participate in the study
You will not qualify if you...
- Patients with language barriers or comprehension difficulties
- Patients under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière
Paris, France, 7013
Actively Recruiting
Research Team
M
Maëlys TENG, MD, MSc
CONTACT
G
Gerard AMARENCO, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here