Clinical trial NCT04657588: Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial
Official title: Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Faecal Incontinence
Keywords: faecal incontinence
Anal device
Navina anal insert
Self-help instrument
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 73
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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 16-85 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 16-85 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.

Primary outcomes:
measure: Change in FI severity
timeFrame: 8 weeks
Secondary outcomes:
measure: Cost effectiveness (direct medical costs)
timeFrame: 8 weeks
measure: Cost effectiveness (Costs due to loss of productivity)
timeFrame: 8 weeks
measure: Mental health (anxiety)
timeFrame: 8 weeks
measure: Mental health (depression)
timeFrame: 8 weeks
measure: Quality of life (QoL) (general QoL)
timeFrame: 8 weeks
measure: Quality of life (QoL) (disease specific QoL)
timeFrame: 8 weeks
measure: Adherence to therapy
timeFrame: 8 weeks
measure: Wellbeing
timeFrame: 8 weeks
measure: Frequency and severity of adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: Limburg
Study officials:
References: