An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter. In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI. Each subject will be followed during approximately one week, depending on the usual time between their TAI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
13
Transanal irrigation (TAI) with new catheter on subjects experienced in using TAI with balloon catheter.
Proctos Kliniek
Bilthoven, MB Bilthoven, Netherlands
Catheter stay in place
Does the catheter stay in place during water instillation? Yes/No
Time frame: 1 week
Bowel emptying performance
Evaluation of bowel emptying performance: Subject's perception of emptying of bowel similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of emptying of bowel with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better
Time frame: 1 week
Leakage
Evaluation of leakage during water instillation: Subject's perception of leakage similar to regular use of TAI. Descriptive analysis of data from questionnaires at Visit 2 and 3 collected from subject's previous experience from using balloon catheter comparing it with experience of using two different sizes of study catheters during study. Question asked: "What is the subject's perception of leakage with the study catheter compared to their regular use with a balloon catheter?" Potential response: much worse, worse, same, better, much better
Time frame: 1 week
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