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

NACompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

June 6, 2021

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
Faecal Incontinence
Interventions
DEVICE

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.

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.

Trial Locations (1)

6229HX

Maastricht University Medical Centre, Maastricht

All Listed Sponsors
lead

Maastricht University Medical Center

OTHER