An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents

Inclusion Criteria:

• Signed informed consent

• Male and female children/adolescents between 3 and 17 years of age at the time ofinclusion

• Diagnosis of at least one of the following:

• functional constipation not well treated with oral laxatives

• functional fecal incontinence, either retentive or non-retentive (FNRFI:Functional Non-Retentive Fecal Incontinence) not well treated with orallaxatives

• neurogenic bowel dysfunction due to spinal abnormalities and/or spinal cordinjury or cerebral palsy

• patient with sequelae of anorectal malformations to Hirschsprung disease

• Fecal Incontinence (FI) due to iatrogenic injury including tumor surgerysequelae

• Symptom duration of > 3 months

• Subject and/or their legally designated representative can communicate in writtenand oral Swedish language

Exclusion Criteria:

• Children/adolescents previously treated with, or currently in need of, high volumeTAI, i.e., volume > 250 ml

• Confirmed pregnancy at the time of enrollment

• Participating in another clinical investigation interfering with this investigation

• Subjects with an active, symptomatic, inflammatory bowel disease, radiationproctitis, and or active perianal fistula disease

• Rectal bleeding of uncertain origin or active hemorrhoidal bleeding

• < 6 months after anal or colorectal surgery

• Ongoing anti-coagulant therapy (i.e., NOACS, heparin, warfarin)

• Ischemic colitis

• Active anal fissure

• Inability to use the product or anyone to assist in its usage (hand functionassessment)

• Person not suitable for the investigation according to the investigator's judgment