Faecal incontinence involuntary soiling
Conditions
Interventions
Group 1 will be given Navina* Fecal Incontinence Inserts for a 1-week
accommodation period followed by 8-weeks treatment period. Group 2 will asked
to continue with care as usual (e.g. incontinence
Sponsors
Universiteit Maastricht
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with FI according to Rome IV criteria (i.e. recurrent uncontrolled passage of faecal matter for at least 3 months) - Aged between 16-90 years - Patients who experience at least 1 episode of accidental bowel leakage during the 2 week run-in period will be eligible for randomisation.
Exclusion criteria
Exclusion criteria: - Insufficient cognitive skills to fill in patient-reported questionnaires, inability to present to hospital for screening visit and inclusion, neurological/psychiatric or physical inability to comply with the study protocol (including diary assessments) at the investigator*s discretion, or insufficient command of the Dutch language. - Anatomic abnormalities: known communication between the anal and vaginal tracts, prior diagnosis of congenital anorectal malformations, previous rectal surgery, radiotherapy to a pelvic organ (uterus, prostate, rectum). - Prior diagnosis of inflammatory bowel disease. - Pregnancy or intention to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A clinically meaningful decrease in severity of faecal incontinence after the 8-week treatment period, measured using the St. Marks/Vaizey incontinence score (range 0-24) defined as a decrease of >= 3 points. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Quality of life both general and disease specific after 8 weeks of treatment measured using the EQ-5D-5L and Faecal Incontinence quality of life (FIQL) scales respectively. - Cost effectiveness as determined by calculations incorporating total treatment costs and changes in EQ-5D-5L (QALYs gained) and MCQ/PCQ results (savings from reduced medical resource use and increased work productivity respectively). - Adherence to therapy - Psychological characteristics; specifically anxiety and depression (tested using the Generalized Anxiety Disorders Assessment (GAD7), the Patient Health Questionnaire (PHQ9, to assess depressive symptoms). In addition, we will administer the Dutch ICE-CAP-A, a questionnaire that measures wellbeing in terms of capabilities like attachment; security (thinking about the future without concern); role (doing things that make you feel valued); enjoyment and pleasure; control (independence). - Number and severity of adverse events | — |
Countries
Netherlands
Outcome results
None listed