A multi center study to evaluate efficacy and safety of NASHA/Dx gel for the treatment of fecal incontinence: LTP02


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Abstract

Aim:The biocompatible injectable bulking agent NASHA/Dx gel (SolestaTM, Q-Med, Sweden) is approved for endoanal treatment of fecal incontinence (FI). This open non-comparative post marketing study was performed to evaluate efficacy and safety of NASHA/Dx in the treatment of FI.Method:Patients suffering from > 4 FI episodes over a 28 day period received 4-quadrant anal injection of 1 ml NASHA/Dx gel. They were followed for up to 12 months. The number of FI episodes was collected in patient diaries over 4 weeks. Response was defined as > 50% reduction in total number of FI episodes as compared to baseline.Results:One hundred fifteen patients were treated at 15 centers throughout Europe and Canada. Twenty four patients withdrew before 12 months. Six serious related AEs have been recorded, including abscess (3) or pain (3). At 12 months follow up, 55 patients (64.0%) experienced >50% reduction in total number of FI episodes. The mean number of FI episodes declined by 49.4%, and FI free days increased by 85.2%. Quality of life and Fecal Incontinence Quality of Life were significantly improved at 12 months compared to baseline.Conclusion:treatment of FI with NASHA/Dx is safe and effective, with >60% of patients experiencing a > 50% reduction in total number of FI episodes.

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