- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04657588
Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)
September 27, 2022 updated by: Maastricht University Medical Center
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 (myMiracle)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sadé Assmann, Bsc
- Phone Number: +31433882354
- Email: s.assmann@maastrichtuniversity.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229HX
- Recruiting
- Maastricht University Medical Centre
-
Contact:
- Daniel Keszthelyi
- Email: daniel.keszthelyi@maastrichtuniversity.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 83 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anal insert
This group will be asked to use anal inserts to help manage their faecal incontinence during the treatment period
|
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.
Other Names:
|
Sham Comparator: Care as usual
This group will be asked to continue with their care as usual (e.g.
incontinence pads)
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost effectiveness (direct medical costs)
Time Frame: 8 weeks
|
Determined through the Medical consumption questionnaire (MCQ).
|
8 weeks
|
Cost effectiveness (Costs due to loss of productivity)
Time Frame: 8 weeks
|
Determined through the Productivity Cost Questionnaire (PCQ).
|
8 weeks
|
Mental health (anxiety)
Time Frame: 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)
|
8 weeks
|
Mental health (depression)
Time Frame: 8 weeks
|
Measured through the Patient health questionnaire 9 (PHQ-9).
|
8 weeks
|
Quality of life (QoL) (general QoL)
Time Frame: 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).
|
8 weeks
|
Quality of life (QoL) (disease specific QoL)
Time Frame: 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).
|
8 weeks
|
Adherence to therapy
Time Frame: 8 weeks
|
Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not
|
8 weeks
|
Wellbeing
Time Frame: 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).
|
8 weeks
|
Frequency and severity of adverse events
Time Frame: 8 weeks
|
Any adverse events possibly related to the anal insert will be recorded
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2021
Primary Completion (Anticipated)
September 1, 2023
Study Completion (Anticipated)
September 1, 2023
Study Registration Dates
First Submitted
October 13, 2020
First Submitted That Met QC Criteria
December 1, 2020
First Posted (Actual)
December 8, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2022
Last Update Submitted That Met QC Criteria
September 27, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 75495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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