Faecal Incontinence
Conditions
Keywords
faecal incontinence, Anal device, Navina anal insert, Self-help instrument
Brief summary
The purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)
Detailed description
After being informed about the study including the potential pros and cons, patients will be given a minimum of 7 days to think about whether they would like to participate in the study. If they would like to participate, and informed consent form will need to be signed, after which the patients will undergo a screening to ensure they meet the inclusion criteria. A 2 week run-in period will take place to let patients get used to filling in an electronic daily diary. Prior to this period, patients will be asked to fill out several questionnaires. After this period, randomisation into either (1) the anal insert group or (2) the care as usual group. Group 1 will then have an 'accommodation' week in which they can try out two different sizes of the anal insert to see which size they would prefer for the treatment period. The treatment period will consist of 8 weeks In which the (1) anal insert group is expected to use the anal inserts and the (2) care as usual group is asked to continue with their treatment as usual. During the treatment period, patients will fill out an electronic daily diary as well as weekly questionnaires.At the end of the 8 week treatment period, patients will fill out additional questionnaires. The follow-up consists of 4 weeks, after which patients will be asked again to fill out several questionnaires.
Interventions
DEVICENavina anal insert
The Navina anal device is a single-use, pre-lubricated, liquid-filled rectal insert with a plastic applicator. The insert is filled with liquid mineral oil. The primary advantage of this new instrument is the fact that the liquid-filled insert will move and adapt as the fluid is transferred throughout the device making it easy to insert/remove and comfortable to wear. The design is intended to adjust to the contours of the individual anatomy to prevent leakage.
OTHERCare as usual
Care as usual means participants are to continue their usual treatment for FI, like they would if they would not have participated in this study.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
multicenter randomized controlled open-label superiority trial with adaptive design in ambulatory patients with FI with two parallel treatment arms: anal inserts and care as usual (incontinence pads).
Eligibility
Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
For run in period * 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 For randomisation and treatment period * 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
* 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 | Description |
|---|---|---|
| Change in FI severity | 8 weeks | Measured using the St. Marks/vaizey incontinence score. This scale ranges from 0 (complete continence = best score) to 24 (complete incontinence= worst score). We are particularly interested in whether a clinically meaningful decrease of ≥3 points will occur in the intervention group compared to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost effectiveness (Costs due to loss of productivity) | 8 weeks | Determined through the Productivity Cost Questionnaire (PCQ). |
| Mental health (anxiety) | 8 weeks | Measured through the Generalized anxiety disorder (GAD-7) questionnaire. This questionnaire contains 7 questions which can each be given a score of 0 to 3. A total score of 0= no anxiety (the best), a total score of 21= severe anxiety (the worst) |
| Mental health (depression) | 8 weeks | Measured through the Patient health questionnaire 9 (PHQ-9). |
| Quality of life (QoL) (general QoL) | 8 weeks | Measured through the 5 level EQ-5D questionnaire (EQ-5D-5L). This questionnaire contains 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) which can all individually be scored on a scale of 0 (best) to 5(worst). Additionally participants are asked to score their health for that day from a score of 0 (worst health you can imagine) to a score of 100 (best health you can imagine). |
| Cost effectiveness (direct medical costs) | 8 weeks | Determined through the Medical consumption questionnaire (MCQ). |
| Adherence to therapy | 8 weeks | Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not |
| Wellbeing | 8 weeks | Measured through the ICEpop CAPability measure for adults (ICE-CAP-A) questionnaire. To measure 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). Each of the 5 items can be given a score of 1 (worst) to 4 (best). |
| Frequency and severity of adverse events | 8 weeks | Any adverse events possibly related to the anal insert will be recorded |
| Quality of life (QoL) (disease specific QoL) | 8 weeks | Measured through the Faecal incontinence Quality of life scale (FIQL). This questionnaire contains 24 items which can be scored from 1( worst) to 4,5 or 6 (best) depending on the item. Patients can score a minimum of 29 points (worst QoL) to a maximum of 119 points (best QoL). |
Countries
Netherlands
Outcome results
None listed