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

NCT04657588 | Completed DMC

• 1 other identifier: 75495
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

faecal incontinence; Anal device; Navina anal insert; Self-help instrument

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cost effectiveness (direct medical costs)

  8 weeks

• Cost effectiveness (Costs due to loss of productivity)

  8 weeks

• Mental health (anxiety)

  8 weeks

• Mental health (depression)

  8 weeks

• Quality of life (QoL) (general QoL)

  8 weeks

Study Arms (2)

Anal insert

EXPERIMENTAL

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

Device: Navina anal insert

Care as usual

SHAM COMPARATOR

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

Other: Care as usual

Interventions

Navina anal insert 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.

Also known as: anal plug

Anal insert

Care as usual 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.

Also known as: Comparator

Care as usual

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: December 8, 2020
• Study Start: June 6, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)