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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 \u226550% 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 (<mml:math xmlns:mml=\"http:\/\/www.w3.org\/1998\/Math\/MathML\"><mml:mi>P<\/mml:mi><mml:mo>&lt;<\/mml:mo><mml:mo>.<\/mml:mo><mml:mn>001<\/mml:mn><\/mml:math>) 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.<\/jats:p>","DOI":"10.1155\/2010\/467136","type":"journal-article","created":{"date-parts":[[2010,12,27]],"date-time":"2010-12-27T19:37:47Z","timestamp":1293478667000},"page":"1-10","source":"Crossref","is-referenced-by-count":26,"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"],"prefix":"10.1155","volume":"2010","author":[{"given":"Giuseppe","family":"Dodi","sequence":"first","affiliation":[{"name":"Universit\u00e0 degli Studi di Padova Hospital Clinica Chirurgica, Via Giustiniani 2, 35128 Padova, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Jongen","sequence":"additional","affiliation":[{"name":"Proktologische Praxis Kiel, Beselerallee 67, 24105 Kiel, 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