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

Faecal Incontinence Clinical Trial

— CONFIDEnCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04657588
• Other study ID #: 75495
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2022
• Source: Maastricht University Medical Center
• Contact: Sadé Assmann, Bsc
• Phone: +31433882354
• Email: s.assmann[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (myMiracle)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Intervention

Device:
• myMiracle anal insert
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:
• Care as usual
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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks
Secondary	Cost effectiveness (direct medical costs)	Determined through the Medical consumption questionnaire (MCQ).	8 weeks
Secondary	Cost effectiveness (Costs due to loss of productivity)	Determined through the Productivity Cost Questionnaire (PCQ).	8 weeks
Secondary	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)	8 weeks
Secondary	Mental health (depression)	Measured through the Patient health questionnaire 9 (PHQ-9).	8 weeks
Secondary	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).	8 weeks
Secondary	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).	8 weeks
Secondary	Adherence to therapy	Checking whether patients in the anal insert group (intervention) decided to use the anal inserts or not	8 weeks
Secondary	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).	8 weeks
Secondary	Frequency and severity of adverse events	Any adverse events possibly related to the anal insert will be recorded	8 weeks