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Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence

BACKGROUND: Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the...

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Autores principales: Mellgren, A, Matzel, K E, Pollack, J, Hull, T, Bernstein, M, Graf, W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4371654/
https://www.ncbi.nlm.nih.gov/pubmed/24837493
http://dx.doi.org/10.1111/nmo.12360
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author Mellgren, A
Matzel, K E
Pollack, J
Hull, T
Bernstein, M
Graf, W
author_facet Mellgren, A
Matzel, K E
Pollack, J
Hull, T
Bernstein, M
Graf, W
author_sort Mellgren, A
collection PubMed
description BACKGROUND: Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms. METHODS: In a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder(50)). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated. KEY RESULTS: Successful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort. CONCLUSIONS & INFERENCES: Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years.
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spelling pubmed-43716542015-03-26 Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence Mellgren, A Matzel, K E Pollack, J Hull, T Bernstein, M Graf, W Neurogastroenterol Motil Original Articles BACKGROUND: Injectable bulking treatment for fecal incontinence (FI) is intended to expand tissue in the anal canal and prevent fecal leakage. Use of injectable bulking agents is increasing because it can be performed in an outpatient setting and with low risk for morbidity. This study evaluated the long-term (36-month) clinical effectiveness and safety of injection of non-animal stabilized hyaluronic acid/dextranomer (NASHA Dx) on FI symptoms. METHODS: In a prospective multicenter trial, 136 patients with FI received the NASHA Dx bulking agent. Treatment success defined as a reduction in number of FI episodes by 50% or more compared with baseline (Responder(50)). Change from baseline in Cleveland Clinic Florida Fecal Incontinence Score (CCFIS) and Fecal Incontinence Quality of Life Scale (FIQL), and adverse events were also evaluated. KEY RESULTS: Successful decrease in symptoms was achieved in 52% of patients at 6 months and this was sustained at 12 months (57%) and 36 months (52%). Mean CCFIS decreased from 14 at baseline to 11 at 36 months (p < 0.001). Quality-of-life scores for all four domains improved significantly between baseline and 36 months of follow-up. Severe adverse events were rare and most adverse events were transient and pertained to minor bleeding and pain or discomfort. CONCLUSIONS & INFERENCES: Submucosal injection of NASHA Dx provided a significant improvement of FI symptoms in a majority of patients and this effect was stable during the course of the follow-up and maintained for 3 years. BlackWell Publishing Ltd 2014-08 2014-05-19 /pmc/articles/PMC4371654/ /pubmed/24837493 http://dx.doi.org/10.1111/nmo.12360 Text en © 2014 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by-nc-nd/3.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Mellgren, A
Matzel, K E
Pollack, J
Hull, T
Bernstein, M
Graf, W
Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title_full Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title_fullStr Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title_full_unstemmed Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title_short Long-term efficacy of NASHA Dx injection therapy for treatment of fecal incontinence
title_sort long-term efficacy of nasha dx injection therapy for treatment of fecal incontinence
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4371654/
https://www.ncbi.nlm.nih.gov/pubmed/24837493
http://dx.doi.org/10.1111/nmo.12360
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