Faecal IncontinenceCONFIDEnCENCT04657588
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial
A study testing Navina anal insert and Care as usual in people with Faecal Incontinence, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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) Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Faecal Incontinence
- What is being tested?
- Navina anal insert and Care as usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Jun 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, Limburg, 6229HX
About this study
Official title: Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
The purpose of this study is to assess the cost-effectiveness and improvement in quality of life of using a novel anal insert (navina)
Read the 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.
- Conditions
- Faecal Incontinence
- Being tested
- Navina anal insert, Care as usual
- Keywords
- faecal incontinence, Anal device, Navina anal insert, Self-help instrument
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navina anal insertDevice
Also called anal plug
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.
Care as usualOther
Also called Comparator
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.
| Study group | Role | What they receive |
|---|---|---|
| Anal insert | Experimental | This group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period Receives: Device: Navina anal insert |
| Care as usual | Sham comparator | This group will be asked to continue with their care as usual (e.g. incontinence pads) Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FI severity
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.
Measured: 8 weeks
Secondary outcomes (9)
Cost effectiveness (direct medical costs)
Determined through the Medical consumption questionnaire (MCQ).
Measured: 8 weeks
Cost effectiveness (Costs due to loss of productivity)
Determined through the Productivity Cost Questionnaire (PCQ).
Measured: 8 weeks
Mental health (anxiety)
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)
Measured: 8 weeks
Mental health (depression)
Measured through the Patient health questionnaire 9 (PHQ-9).
Measured: 8 weeks
Quality of life (QoL) (general QoL)
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).
Measured: 8 weeks
Quality of life (QoL) (disease specific QoL)
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).
Measured: 8 weeks
Adherence to therapy
Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not
Measured: 8 weeks
Wellbeing
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).
Measured: 8 weeks
Frequency and severity of adverse events
Any adverse events possibly related to the anal insert will be recorded
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start6 Jun 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657588
- Sponsor's protocol ID
- 75495
- Acronym
- CONFIDEnCE
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assmann SL, Winkens B, Bours A, Essers B, Lam T, Mujagic Z, Breukink SO, Keszthelyi D. Controlling Fecal Incontinence With a Novel Anal Device: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e269208. doi: 10.1001/jamanetworkopen.2026.9208.
PubMed 42048080
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
- ClinicalTrials.gov ID
- NCT04657588
- Acronym / sponsor ID
- CONFIDEnCE / 75495
- Conditions
- Faecal Incontinence
- Keywords
- faecal incontinence, Anal device, Navina anal insert, Self-help instrument
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Anal insert | Experimental | Device: Navina anal insertThis group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period |
| Care as usual | Sham comparator | Other: Care as usualThis group will be asked to continue with their care as usual (e.g. incontinence pads) |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navina anal insertAlso: anal plugThe 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. | Device | Anal insert |
| Care as usualAlso: ComparatorCare as usual means participants are to continue their usual treatment for FI, like they would if they would not have participated in this study. | Other | Care as usual |
Primary outcome
Change in FI severity
Time frame: 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.
9 secondary outcomes
Cost effectiveness (direct medical costs)
Time frame: 8 weeks
Cost effectiveness (Costs due to loss of productivity)
Time frame: 8 weeks
Mental health (anxiety)
Time frame: 8 weeks
Mental health (depression)
Time frame: 8 weeks
Quality of life (QoL) (general QoL)
Time frame: 8 weeks
Quality of life (QoL) (disease specific QoL)
Time frame: 8 weeks
Adherence to therapy
Time frame: 8 weeks
Wellbeing
Time frame: 8 weeks
Frequency and severity of adverse events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42048080Assmann SL, Winkens B, Bours A, Essers B, Lam T, Mujagic Z, Breukink SO, Keszthelyi D. Controlling Fecal Incontinence With a Novel Anal Device: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e269208. doi: 10.1001/jamanetworkopen.2026.9208.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navina anal insert and Care as usual in people with Faecal Incontinence, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FI severity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04657588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.