The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures. The primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.
The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and/or time-consuming bowel management procedures. The primary endpoint is bowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit and end of Clinical Investigation visit. Participants will use Peristeen Light for 12 weeks test period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Subjects naive to TAI will use Peristeen Light trans anal irrigation
Århus University Hospital
Aarhus, Gotland, Denmark
RECRUITINGMontecatone Rehabillitation Institute S.p.A
Bologna, Italy
RECRUITINGBowel function measured on a 10 cm Visual Analog Scale (VAS) at Baseline Visit (V1) and End of Clinical Investigation Visit (V7).
0 cm = worst possible bowel function and 10 cm = best possible bowel function.
Time frame: From enrollment to the end of treatment at week 12.
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