Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Faecal Incontinence

Treatments: Other: Care as usual; Device: Navina anal insert

Study type: Interventional

Funder types: Other

Identifiers

NCT04657588

75495

Details and patient eligibility

About

The purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 16 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Anal insert

Experimental group

Description:

This group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period

Treatment:

Device: Navina anal insert

Care as usual

Sham Comparator group

Description:

This group will be asked to continue with their care as usual (e.g. incontinence pads)

Treatment:

Other: Care as usual