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Title: An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence
Authors: Dodi, Giuseppe
Jongen, Johannes
de la Portilla, Fernando
Raval, Manoj
Altomare, Donato F
Lehur, Paul-Antoine
metadata.dc.contributor.authoraffiliation: [Dodi,G] Universita degli Studi di Padova Hospital Clinica Chirurgica, Padova, Italy. [Jongen,J] Proktologische Praxis Kiel, Kiel, Germany. [de la Portilla,F] Coloproctology Section, Department of Surgery, Virgen del Rocio University Hospital,Seville, Spain. [Raval,M] St. Paul’s Hospital, Vancouver, Canada. [Altomare,DF] Coloproctological Unit of Bari Policinico di Bari Piazza, University of Bari, Bari, Italy. [Lehur,PA] Clinique Chirurgicale, chu-Hotel-Dieu, Institut des Maladies de l’Appareil Digestif, Nantes Cedex, France
Keywords: Incontinencia fecal;Canal Anal;Dextranos;Humanos;Inyecciones;Calidad de vida;Prevalencia
metadata.dc.subject.mesh: Medical Subject Headings::Diseases::Digestive System Diseases::Gastrointestinal Diseases::Intestinal Diseases::Rectal Diseases::Fecal Incontinence
Medical Subject Headings::Anatomy::Digestive System::Gastrointestinal Tract::Intestines::Intestine, Large::Anal Canal
Medical Subject Headings::Chemicals and Drugs::Macromolecular Substances::Polymers::Biopolymers::Glucans::Dextrans
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Injections
Medical Subject Headings::Disciplines and Occupations::Social Sciences::Quality of Life
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Morbidity::Prevalence
Issue Date: 2010
Publisher: Hindawi Publishing Corporation
Citation: Dodi G, Jongen J, de la Portilla F, Raval M, Altomare DF, Lehur PA. An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence. Gastroenterol Res Pract; 2010:467136
Abstract: Fecal incontinence (FI) is the involuntary loss of rectal contents through the anal canal. Reports of its prevalence vary from 1-21%. Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents. This study evaluated the safety and efficacy of NASHA/Dx gel in the treatment of FI. One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA/Dx gel. Primary efficacy was based on data from 86 patients that completed the study. This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months. Significant improvements (P < .001) were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains. The majority of the treatment related AEs (94.9%) were mild or moderate intensity, and (98.7%) of AEs resolved spontaneously, or following treatment, without sequelae. Results of this study indicate NASHA/Dx gel was efficacious in the treatment of FI. Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment.
Description: Journal Article;
metadata.dc.identifier.doi: 10.1155/2010/467136
ISSN: 1687-630X (Online)
1687-6121 (Print)
Appears in Collections:01- Artículos - Hospital Virgen del Rocío

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