search
Back to results

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

Primary Purpose

Faecal Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
myMiracle anal insert
Care as usual
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Faecal Incontinence focused on measuring faecal incontinence, Anal device, Navina anal insert, Self-help instrument

Eligibility Criteria

16 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept 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 16-85 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.

Sites / Locations

  • Maastricht University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anal insert

Care as usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cost effectiveness (direct medical costs)
Determined through the Medical consumption questionnaire (MCQ).
Cost effectiveness (Costs due to loss of productivity)
Determined through the Productivity Cost Questionnaire (PCQ).
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)
Mental health (depression)
Measured through the Patient health questionnaire 9 (PHQ-9).
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).
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).
Adherence to therapy
Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not
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).
Frequency and severity of adverse events
Any adverse events possibly related to the anal insert will be recorded

Full Information

First Posted
October 13, 2020
Last Updated
September 27, 2022
Sponsor
Maastricht University Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04657588
Brief Title
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial
Acronym
CONFIDEnCE
Official Title
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2021 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 (myMiracle)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence
Keywords
faecal incontinence, Anal device, Navina anal insert, Self-help instrument

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anal insert
Arm Type
Experimental
Arm Description
This group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period
Arm Title
Care as usual
Arm Type
Sham Comparator
Arm Description
This group will be asked to continue with their care as usual (e.g. incontinence pads)
Intervention Type
Device
Intervention Name(s)
myMiracle anal insert
Other Intervention Name(s)
anal plug
Intervention Description
The myMiracle 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.
Intervention Type
Other
Intervention Name(s)
Care as usual
Other Intervention Name(s)
Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in FI severity
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Cost effectiveness (direct medical costs)
Description
Determined through the Medical consumption questionnaire (MCQ).
Time Frame
8 weeks
Title
Cost effectiveness (Costs due to loss of productivity)
Description
Determined through the Productivity Cost Questionnaire (PCQ).
Time Frame
8 weeks
Title
Mental health (anxiety)
Description
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)
Time Frame
8 weeks
Title
Mental health (depression)
Description
Measured through the Patient health questionnaire 9 (PHQ-9).
Time Frame
8 weeks
Title
Quality of life (QoL) (general QoL)
Description
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).
Time Frame
8 weeks
Title
Quality of life (QoL) (disease specific QoL)
Description
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).
Time Frame
8 weeks
Title
Adherence to therapy
Description
Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not
Time Frame
8 weeks
Title
Wellbeing
Description
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).
Time Frame
8 weeks
Title
Frequency and severity of adverse events
Description
Any adverse events possibly related to the anal insert will be recorded
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sadé Assmann, Bsc
Phone
+31433882354
Email
s.assmann@maastrichtuniversity.nl
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Keszthelyi
Email
daniel.keszthelyi@maastrichtuniversity.nl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs