1. Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up
- Author
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Lieschen H, Quiroz, Domingo E, Galliano, Giovanna, da Silva, Joseph C, Carmichael, Li-Chen, Pan, Emilie R, Bromley, Jordan, Hinahara, and Thomas F, Goss
- Subjects
Adult ,Male ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Gastroenterology ,Bayes Theorem ,General Medicine ,Clinical Research ,Quality of Life ,Humans ,Female ,Surgery ,Prospective Studies ,Hyaluronic Acid ,Digestive Diseases ,Fecal Incontinence ,Follow-Up Studies - Abstract
BackgroundFecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens.ObjectiveThe primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application.DesignThis was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study.SettingsThis study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coordination with the Food and Drug Administration and the study sponsor.PatientsA total of 283 subjects who previously failed conservative therapy were enrolled across 18 US sites.InterventionsParticipants received 1 to 2 nonanimal stabilized hyaluronic acid/dextranomer treatments. The first treatment occurred within 30 days of baseline, and a second treatment was administered 1 to 3 months after initial treatment if determined necessary by the physician. Subjects were followed through 7 visits over 36 months after last treatment.Main outcome measuresEfficacy (as specified by the Food and Drug Administration) was measured as a fecal incontinence reintervention rate of
- Published
- 2023