CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Navina anal insert +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04657588
NCT04657588N/ACompleted
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Controlling Faecal Incontinence With a Novel Anal Device: a Cost-effectiveness Trial (CONFIDEnCE)

Maastricht University Medical Center·interventional·Posted Dec 8, 2020·Updated Dec 18, 2025

In Brief

A clinical study evaluating Navina anal insert and Care as usual for Faecal Incontinence. Completed, enrolled 73 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFaecal Incontinence
CountriesNetherlands
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 8, 2020
Enrollment StartJun 6, 2021
Primary CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.6 years ago

Interventions

Navina anal insertdevice

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

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.