RT Journal Article
T1 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
A1 Dodi, Giuseppe
A1 Jongen, Johannes
A1 de la Portilla, Fernando
A1 Raval, Manoj
A1 Altomare, Donato F
A1 Lehur, Paul-Antoine
K1 Incontinencia fecal
K1 Canal Anal
K1 Dextranos
K1 Humanos
K1 Inyecciones
K1 Calidad de vida
K1 Prevalencia
AB 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.
PB Hindawi Publishing Corporation
SN 1687-6121
YR 2010
FD 2010
LK http://hdl.handle.net/10668/2068
UL http://hdl.handle.net/10668/2068
LA en
NO 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
NO Journal Article;
DS RISalud
RD Apr 18, 2025