Bowel Dysfunction
Conditions
Brief summary
This is an un-controlled, prospective, multi center, post market clinical follow-up investigation that will enroll male and female subjects in need of bowel management with low-volume transanal irrigation (TAI) as judged by the investigator. A total of 40 investigational subjects in need of low-volume TAI will be recruited from 2-3 sites in Sweden and will be treated with Navina Mini as per product intended purpose and per instruction of use during a period of four weeks. Participating subjects will perform three visits during the clinical investigation and will be followed for a total of four weeks. The first visit, Visit 1, will be performed at the investigational clinic to assess eligibility, collect demographics, baseline data and instruct how to use the device. Visit 2 will be performed after two weeks of treatment through telephone contact. The final visit, Visit 3, will be performed after additional two weeks of treatment, and can be performed either at the investigational clinic or through telephone contact.
Interventions
DEVICENavina Mini
CE-marked Navina Mini, released on the market May 2023
Sponsors
Wellspect HealthCare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Anal incontinence or faecal outlet problems without any pathological obstruction in the ano-rectum. * Symptom duration of \> 6 months * Adult male and females \>18 years old * Patient can communicate in written and oral Swedish language
Exclusion criteria
* Subjects treated with high volume TAI i.e., volume \> 250 ml * Pregnancy at the time of enrollment * Participating in another clinical investigation interfering with this investigation * Subjects with active, symptomatic inflammatory bowel disease, radiation proctitis 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 (eg. NOACS, heparin, Warfarin) * Acute diverticulitis and diverticular abscess * Ischemic colitis * Colorectal cancer * Any physical handicap that prevents usage of product * Inability to use product or anyone to assist in its usage * Person not suitable for the investigation according to the investigator judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 4 weeks | Patient Reported Outcome - Overall patient satisfaction when performing low- volume trans-anal irrigation measured with a 5-graded scale \[0 = Not at all satisfied, 1 = Not satisfied, 2 = Neither satisfied nor unsatisfied, 3=Satisfied, 4 = Very satisfied\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of clinical benefit | 4 weeks | Patient Reported Outcome on Fecal Incontinence and Defecation syndrome |
| Ease of handling | 4 weeks | Patient Reported Outcome on perception of handling the device |
| Safety Outcome | 4 weeks | Assessment of adverse events and device deficiencies |
Countries
Sweden
Outcome results
None listed