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.
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.
authors.affiliation: Università degli Studi di Padova Hospital Clinica Chirurgica, Via Giustiniani 2, 35128 Padova, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Dodi
authors.forename: Johannes
authors.initials: J
authors.lastname: Jongen
authors.forename: Fernando
authors.initials: F
authors.lastname: de la Portilla
authors.forename: Manoj
authors.initials: M
authors.lastname: Raval
authors.forename: Donato F
authors.initials: DF
authors.lastname: Altomare
authors.forename: Paul-Antoine
authors.initials: PA
authors.lastname: Lehur