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

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An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. / Emmanuel, Anton; Kurze, Ines; Krogh, Klaus; Velasco, Maria Elena Ferreiro; Christensen, Peter; Popolo, Giuilio Del; Bazzocchi, Gabriele; Hultling, Claes; Verbe, Brigitte Perrouin; Bothig, Ralf; Glott, Thomas; Viejo, Miguel Angel Gonzalez.

I: PLOS ONE, Bind 16, Nr. 1 , e0245453, 01.2021.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

Harvard

Emmanuel, A, Kurze, I, Krogh, K, Velasco, MEF, Christensen, P, Popolo, GD, Bazzocchi, G, Hultling, C, Verbe, BP, Bothig, R, Glott, T & Viejo, MAG 2021, 'An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction', PLOS ONE, bind 16, nr. 1 , e0245453. https://doi.org/10.1371/journal.pone.0245453

APA

Emmanuel, A., Kurze, I., Krogh, K., Velasco, M. E. F., Christensen, P., Popolo, G. D., Bazzocchi, G., Hultling, C., Verbe, B. P., Bothig, R., Glott, T., & Viejo, M. A. G. (2021). An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLOS ONE, 16(1 ), [e0245453]. https://doi.org/10.1371/journal.pone.0245453

CBE

Emmanuel A, Kurze I, Krogh K, Velasco MEF, Christensen P, Popolo GD, Bazzocchi G, Hultling C, Verbe BP, Bothig R, Glott T, Viejo MAG. 2021. An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. PLOS ONE. 16(1 ):Article e0245453. https://doi.org/10.1371/journal.pone.0245453

MLA

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Author

Emmanuel, Anton ; Kurze, Ines ; Krogh, Klaus ; Velasco, Maria Elena Ferreiro ; Christensen, Peter ; Popolo, Giuilio Del ; Bazzocchi, Gabriele ; Hultling, Claes ; Verbe, Brigitte Perrouin ; Bothig, Ralf ; Glott, Thomas ; Viejo, Miguel Angel Gonzalez. / An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction. I: PLOS ONE. 2021 ; Bind 16, Nr. 1 .

Bibtex

@article{7d288b0b47e14d4c8539c931603f3278,
title = "An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction",
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) na{\"i}ve 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.",
author = "Anton Emmanuel and Ines Kurze and Klaus Krogh and Velasco, {Maria Elena Ferreiro} and Peter Christensen and Popolo, {Giuilio Del} and Gabriele Bazzocchi and Claes Hultling and Verbe, {Brigitte Perrouin} and Ralf Bothig and Thomas Glott and Viejo, {Miguel Angel Gonzalez}",
note = "Publisher Copyright: Copyright: {\textcopyright} 2021 Emmanuel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",
year = "2021",
month = jan,
doi = "10.1371/journal.pone.0245453",
language = "English",
volume = "16",
journal = "P L o S One",
issn = "1932-6203",
publisher = "public library of science",
number = "1 ",

}

RIS

TY - JOUR

T1 - An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction

AU - Emmanuel, Anton

AU - Kurze, Ines

AU - Krogh, Klaus

AU - Velasco, Maria Elena Ferreiro

AU - Christensen, Peter

AU - Popolo, Giuilio Del

AU - Bazzocchi, Gabriele

AU - Hultling, Claes

AU - Verbe, Brigitte Perrouin

AU - Bothig, Ralf

AU - Glott, Thomas

AU - Viejo, Miguel Angel Gonzalez

N1 - Publisher Copyright: Copyright: © 2021 Emmanuel et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/1

Y1 - 2021/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85100300199&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0245453

DO - 10.1371/journal.pone.0245453

M3 - Journal article

C2 - 33513187

AN - SCOPUS:85100300199

VL - 16

JO - P L o S One

JF - P L o S One

SN - 1932-6203

IS - 1

M1 - e0245453

ER -