An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction

PLoS ONE, 2021 · DOI: https://doi.org/10.1371/journal.pone.0245453 · Published: January 29, 2021

Neurology Gastroenterology Rehabilitation

Simple Explanation

This study examines the effectiveness and safety of an electronic transanal irrigation (TAI) system called Navina Smart for people with neurogenic bowel dysfunction (NBD). NBD is a common issue for individuals with spinal cord injuries (SCI), leading to problems like constipation and incontinence. The study involved 89 individuals with NBD secondary to SCI who were new to TAI treatment. They used the Navina Smart system for three months, and their bowel function and satisfaction were assessed. The results showed that Navina Smart significantly improved bowel function, reduced the severity of NBD symptoms, and increased satisfaction with bowel management. While there were some technical issues with the device, it was generally safe and well-tolerated.

Study Duration

3 Months

Participants

89 SCI individuals

Evidence Level

Not specified

Key Findings

1
The study found a significant decrease in the mean NBD score after three months of using Navina Smart, indicating improved bowel function.
2
Subjects with severe NBD symptoms experienced a notable reduction in their symptom severity, with many improving to milder categories of NBD.
3
The time spent on daily bowel management was significantly reduced, and satisfaction with bowel management increased.

Research Summary

This open, prospective study evaluated the short-term efficacy and safety of the Navina Smart electronic TAI system in individuals with NBD secondary to SCI. Eighty-nine participants, TAI treatment-naïve, were recruited across ten centers in seven countries and followed for three months. The results demonstrated a significant reduction in NBD scores, particularly in subjects with severe symptoms, and an increase in satisfaction with bowel management. The time required for daily bowel management also decreased. While device deficiencies were noted, especially with early versions, the treatment was generally safe. The study suggests Navina Smart is an effective option for managing NBD in SCI patients, warranting further investigation into long-term outcomes.

Practical Implications

Improved Bowel Management

Navina Smart offers an effective, technologically advanced option for individuals with NBD, particularly those with severe symptoms, potentially improving their bowel function and quality of life.

Reduced Burden of Care

The reduction in time spent on daily bowel management suggests that Navina Smart can alleviate the burden of care for individuals with NBD, freeing up time for other activities.

Device Development

Continuous improvements and monitoring of the Navina Smart device can further improve patient outcomes and device reliability.

Study Limitations

1
The study was an open, non-controlled trial, limiting the ability to draw definitive conclusions about the efficacy of Navina Smart compared to other treatments.
2
Device deficiencies, particularly in early versions, affected the recruitment and data collection, potentially impacting the study's power and results.
3
The study only assessed short-term outcomes (3 months), and long-term efficacy and safety data are needed to fully evaluate the benefits and risks of Navina Smart.

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