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

NCT04657588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-12-18

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-06
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657588 on ClinicalTrials.gov