Anton Emmanuel1, Ines Kurze2, Klaus Krogh3, Maria Elena Ferreiro Velasco4, Peter Christensen5, Giuilio Del Popolo6, Gabriele Bazzocchi7, Claes Hultling8, Brigitte Perrouin Verbe9, Ralf Bothig10, Thomas Glott11, Miguel Angel Gonzalez Viejo12. 1. GI Physiology Unit, UCH London, London, United Kingdom. 2. Querschnittgelähmten-Zentrum, Klinik für Paraplegiologie und Neuro-Urologie, Zentralklinik Bad Berka, Bad Berka, Germany. 3. Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark. 4. Unidad de Lesionados Medulares, Complexo Hospitalario Universitario de A Coruña, A Coruña, Spain. 5. Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital, Aarhus, Denmark. 6. Neuro-Urology and Spinal Unit Dpt., Careggi University Hospital, Firenze, Italy. 7. Neurogastroenterology and G.I. Rehabilitation Unit, Montecatone Rehabilitation Institute, Imola, Bologna, Italy. 8. Karolinska University Hospital, Stockholm, Sweden. 9. Hôpital St Jacques, Nantes, France. 10. Dept. Neuro-Urology, BG Klinikum, Hamburg, Germany. 11. Sunnaas Sykehus HF, Alværn, Norway. 12. Vall d'Hebron, Unidad de Lesionados Medulares, Barcelona, Spain.
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. CLINICAL TRIAL: (ClinicalTrials.gov number NCT02979808).
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. CLINICAL TRIAL: (ClinicalTrials.gov number NCT02979808).
Authors: A V Emmanuel; K Krogh; G Bazzocchi; A-M Leroi; A Bremers; D Leder; D van Kuppevelt; G Mosiello; M Vogel; B Perrouin-Verbe; M Coggrave; P Christensen Journal: Spinal Cord Date: 2013-08-20 Impact factor: 2.772
Authors: P Christensen; K Krogh; B Perrouin-Verbe; D Leder; G Bazzocchi; B Petersen Jakobsen; A V Emmanuel Journal: Tech Coloproctol Date: 2015-11-16 Impact factor: 3.781
Authors: Anton Emmanuel; Gayathri Kumar; Peter Christensen; Stuart Mealing; Zenia M Størling; Frederikke Andersen; Steven Kirshblum Journal: PLoS One Date: 2016-08-24 Impact factor: 3.240