Irritation; AnusNCT06805903
Validation of TRansanal Irrigation Adherence scaLe (TRIAL)
An observational study of Irritation; Anus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritation; Anus
- What is being tested?
- TRansanal Irrigation Adherence scaLe
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women over 18 years old using transanal irrigation device
Who may be able to join
- 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.
Who cannot join
- Language barrier and comprehension difficulties
- Patients under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Neuro-urologie et explorations périnéales Hôpital Pitié Salpêtrière
Paris, 7013
Maelys TENG, Dr, 0142162674, maelys.teng@aphp.fr
About this study
Official title: Adherence Assessment in Transanal Irrigation : Validation of the Transanal Irrigation Adherence Scale
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.
Read more
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.
Read the detailed description
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.
Inclusions will be headed during a consultation or a one day follow-up hospitalization in a neuro-urology department. On this day, patients will have a medical consultation and data concerning medical history, treatments, pelvic disorders' characteristics and modalities of use of TAI will be recorded. The patient will also complete the following questionnaires: TRIAL, a numeric scale of TACI effectiveness, Kess, Wexner, STAR-Q (if diagnosed with multiple sclerosis), NBD (if spinal cord injury), which are symptom scores for ano-rectal disorders; PGI-Severity of ano-rectal disorders; PGI-Improvement of ano-rectal disorders with TACI; USP; I-CAS (if using self-catheterization); and a numeric scale assessing the impact of ano-rectal disorders on quality of life.
Then, at home, the patient will complete a diary detailing the frequency of TAI use over 15 days, along with a new TRIAL questionnaire on day 15, which will be mailed back using a pre-stamped envelope provided by the department.
The validation of this new scale about TAI's adherence is part of a will to standardize the evaluation especially in the use of this device in order to identify the difficulties encountered by patients within therapeutic education programs for learning this technique.
- Conditions
- Irritation; Anus
- Being tested
- TRansanal Irrigation Adherence scaLe
- Keywords
- transanal irrigation, adherence, bowel dysfonction, constipation, fecal incontinence
- Medical subject headings
- Constipation, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRansanal Irrigation Adherence scaLeOther
new trans-anal irrigation self-assessment questionnaire in French
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of a transanal irrigation adherence self-questionnaire scale, in French
Measured: 30 months and 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start30 Mar 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritation; AnusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805903
- Sponsor's protocol ID
- APHP241770
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence Assessment in Transanal Irrigation : Validation of the Transanal Irrigation Adherence Scale
- ClinicalTrials.gov ID
- NCT06805903
- Acronym / sponsor ID
- APHP241770
- Conditions
- Irritation; Anus
- Keywords
- transanal irrigation, adherence, bowel dysfonction, constipation, fecal incontinence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Inclusions will be headed during a consultation or a one day follow-up hospitalization in a neuro-urology department. On this day, patients will have a medical consultation and data concerning medical history, treatments, pelvic disorders' characteristics and modalities of use of TAI will be recorded. The patient will also complete the following questionnaires: TRIAL, a numeric scale of TACI effectiveness, Kess, Wexner, STAR-Q (if diagnosed with multiple sclerosis), NBD (if spinal cord injury), which are symptom scores for ano-rectal disorders; PGI-Severity of ano-rectal disorders; PGI-Improvement of ano-rectal disorders with TACI; USP; I-CAS (if using self-catheterization); and a numeric scale assessing the impact of ano-rectal disorders on quality of life.
Then, at home, the patient will complete a diary detailing the frequency of TAI use over 15 days, along with a new TRIAL questionnaire on day 15, which will be mailed back using a pre-stamped envelope provided by the department.
The validation of this new scale about TAI's adherence is part of a will to standardize the evaluation especially in the use of this device in order to identify the difficulties encountered by patients within therapeutic education programs for learning this technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women over 18 years old using transanal irrigation device
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Language barrier and comprehension difficulties
- Patients under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRansanal Irrigation Adherence scaLenew trans-anal irrigation self-assessment questionnaire in French | Other | – |
Primary outcome
Psychometric validation of a transanal irrigation adherence self-questionnaire scale, in French
Time frame: 30 months and 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritation; Anus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maëlys TENG, MD, MSc (0033 1 42 16 36 74, maelys.teng@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric validation of a transanal irrigation adherence self-questionnaire scale, in French (time frame: 30 months and 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026; AzTrials last refreshed its copy on 3 Nov 2026.