Actively Recruiting

Age: 18Years +
All Genders
NCT06805903

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière

Paris, France, 7013

Actively Recruiting

Loading map...

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