N/A
Completed N=20
Investigation of a New Rectal Catheter for Users of Transanal Irrigation
Bowel Management
Source: ClinicalTrials.gov NCT06389396 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Was it Possible to Perform Transanal Irrigation? — 20; 20 Number of participants who replied YES
Summary
The clinical investigation is an exploratory, randomised controlled, open-labelled, crossover investigation.
The clinical investigation will be conducted as a multi-centre clinical investigation in two different clinical investigation sites in Denmark.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Was it Possible to Perform Transanal Irrigation? |
20; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Has given written Informed Consent
- Is at least 18 years old
- Has full legal capacity
- Has used Trans Anal Irrigation (TAI) with balloon catheter for at least 4 weeks prior to inclusion
- Performs TAI minimum 3 times/week
- Is able to follow study procedures assessed by investigator
Exclusion Criteria
- Has known anal or colorectal stenosis
- Has active/recurrent colorectal cancer
- Is within 3 months of anal or colorectal surgery
- Is within 4 weeks of endoscopic polypectomy
- Has ischaemic colitis
- Has acute inflammatory bowel disease
- Has acute diverticulitis
- Is participating in any other clinical study that may interfere with this study (assessed by investigator).
- Is pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT06389396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.