Trial reportPloS one2021
An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction.
Trial report in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02979808 (An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- The efficacy of retrograde and antegrade enemas in the management of low anterior resection syndrome in patients undergoing rectal resection: a systematic review and meta-analysis.BMC gastroenterology · 2025Pooled it
- Clinical management of complications after chronic spinal cord injury: a review of recent advances.Annals of medicine · 2026Review
- Transanal irrigation in clinical practice: a scoping review.International journal of colorectal disease · 2026Article
- Pelvic Floor Rehabilitation in Spinal Cord Injury: Case Series.Clinical medicine & research · 2025Article
- Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use.Spinal cord series and cases · 2023Article
- A cost-effectiveness analysis of Navina Smart on adult patients affected by neurogenic bowel dysfunction.Global & regional health technology assessmentArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 9 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTransanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD).
aimTo investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD.
designWe present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. POPULATION: Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18-77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10).
methodsSubjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects.
resultsPP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%).
conclusionNavina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe. CLINICAL TRIAL: (ClinicalTrials.gov number NCT02979808).
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