dc.contributor
Institut Català de la Salut
dc.contributor
[Emmanuel A] GI Physiology Unit, UCH London, London, United Kingdom. [Kurze I] Querschnittgelähmten-Zentrum, Klinik für Paraplegiologie und Neuro-Urologie, Zentralklinik Bad Berka, Bad Berka, Germany. [Krogh K] Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. [Ferreiro Velasco ME] Unidad de Lesionados Medulares, Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain. [Christensen P] Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital, Aarhus, Denmark. [Del Popolo G] Neuro-Urology and Spinal Unit Dpt., Careggi University Hospital, Firenze, Italy. [Gonzalez Viejo MA] Unitat de Lesionats Medul·lars, Vall d’Hebron Hospital Universitari, Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Emmanuel, Anton
dc.contributor.author
Kurze, Ines
dc.contributor.author
Krogh, Klaus
dc.contributor.author
Ferreiro Velasco, Maria Elena
dc.contributor.author
Christensen, Peter
dc.contributor.author
Del Popolo, Giuilio
dc.contributor.author
González Viejo, Miguel Angel
dc.date.accessioned
2025-10-24T10:26:22Z
dc.date.available
2025-10-24T10:26:22Z
dc.date.issued
2021-06-14T12:52:17Z
dc.date.issued
2021-06-14T12:52:17Z
dc.date.issued
2021-01-29
dc.identifier
Emmanuel A, Kurze I, Krogh K, Ferreiro Velasco ME, Christensen P, Del Popolo G, et al. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLoS One. 2021 Jan 29;16(1):e0245453.
dc.identifier
https://hdl.handle.net/11351/6070
dc.identifier
10.1371/journal.pone.0245453
dc.identifier
000613891400021
dc.identifier.uri
https://hdl.handle.net/11351/6070
dc.description.abstract
Esdeveniments adversos; Aplicacions; Incontinència
dc.description.abstract
Eventos adversos; Aplicaciones; Incontinencia
dc.description.abstract
Adverse events; Apps; Incontinence
dc.description.abstract
Background
Transanal 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).
Aim
To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD.
Design
We 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).
Methods
Subjects 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.
Results
PP 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%).
Conclusion
Navina 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.
dc.description.abstract
The clinical study was full sponsored by Wellspect Healthcare. The funders initiated the study, monitored the conduct phase, and closed the study.
dc.format
application/pdf
dc.publisher
Public Library of Science
dc.relation
PLoS ONE;16(1)
dc.relation
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245453
dc.rights
Attribution 4.0 International
dc.rights
http://creativecommons.org/licenses/by/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Còlon - Malalties
dc.subject
Medicina - Informàtica
dc.subject
DISEASES::Digestive System Diseases::Gastrointestinal Diseases::Intestinal Diseases::Colonic Diseases::Colonic Diseases, Functional::Neurogenic Bowel
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Physical Therapy Modalities::Hydrotherapy::Therapeutic Irrigation
dc.subject
INFORMATION SCIENCE::Information Science::Informatics::Medical Informatics::Medical Informatics Applications
dc.subject
ENFERMEDADES::enfermedades del sistema digestivo::enfermedades gastrointestinales::enfermedades intestinales::enfermedades del colon::enfermedades funcionales del colon::intestino neurogénico
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::modalidades de fisioterapia::hidroterapia::irrigación terapéutica
dc.subject
CIENCIA DE LA INFORMACIÓN::Ciencias de la información::informática::informática médica::aplicaciones de la informática médica
dc.title
An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
