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

NCT ID: NCT04657588

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2024-08-01

Brief Summary

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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

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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

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Faecal Incontinence

Keywords

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faecal incontinence Anal device Navina anal insert Self-help instrument

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Anal insert

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

Group Type EXPERIMENTAL

Navina anal insert

Intervention Type DEVICE

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 usual

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

Group Type SHAM_COMPARATOR

Care as usual

Intervention Type OTHER

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.

Interventions

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Navina anal insert

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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anal plug Comparator

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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75495

Identifier Type: -

Identifier Source: org_study_id