An observational study in Irritation; Anus, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 42 studies in Constipation with a site in France — 5 open to participants now, 5 under way, none of them phase 3. Constipation · France.
Among the 42 studies in Constipation with a site in France, this one is the only one that started in 2026, is one of 8 observational ones, and was the 41st registered.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 126 observational studies indexed under Constipation.
Browse Constipation studies →5 of the 42 studies in Constipation with a site in France are open now, in 1 country. Each count lists the studies.
Of the 98 Constipation studies recruiting now, 32 (33%) set no upper age limit and 51 (52%) stop at 75 or younger; 16 take children under 18; 28 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →42 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 1 started in 2026.
Median enrollment 198 across the 34 interventional studies, 90 across the 8 observational. Of the 36 that completed or were terminated, 5 (14%) have results posted.
24 of 42 have an industry lead sponsor. The 10 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 1 study filed under Constipation — fewer than ten, so there is no comparison to draw.
1 of the studies in Constipation with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04623359University Hospital, RouenUsefulness of High Resolution Manometry in Constipation | 2027-09 |
Among the 42 studies in Constipation with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Men and women over 18 years old using transanal irrigation device
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
new trans-anal irrigation self-assessment questionnaire in French
Psychometric validation of a transanal irrigation adherence self-questionnaire scale, in French
Time frame: 30 months and 15 days
Plan to share: 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.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Access criteria: Researchers who provide a methodologically sound proposal.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Sep 2028, 30 months after the start.
Of 42 non-industry observational studies under Constipation, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 30 months is above that.
Counting every sponsor, half of 52 studies reached it within 26 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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