Therapeutic Irrigation
Conditions
Brief summary
The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation
Interventions
DEVICEIryPump R Set
Sponsors
BBraun Medical SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years old, 2. Patient having signed an informed consent 3. Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results. 4. Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently 5. Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver 6. Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions) 7. Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks. 8. Patient covered by social security
Exclusion criteria
1. Patient with bowel obstruction 2. Patient already participating in another clinical study or who have previously participated in this investigation, 3. Pregnant or breast-feeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of the trans anal irrigation (TAI) procedure | Duration of the study per patient will correspond to the realisation of 5 consecutive TAI in a maximum of 41 days of follow up | The patient will practice TAI following his usual frequency (depending on his intestinal transit). After each TAI, the patient will evaluate the success of the procedure (defined as satisfying output evacuation of the bowel according to the patient usual pattern in term of volume of water instilled and absence of leakages between 2 irrigations). |
Outcome results
None listed