The purpose of this study is to evaluate a new injectable bulking agent for the treatment of fecal incontinence in adult men and women. This study has been designed to assess the safety, effectiveness and performance of Durasphere in adults suffering from fecal incontinence under monitored clinical conditions. The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score as the primary criteria by which success is evaluated.
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The frequency and severity of fecal incontinence symptoms will be measured using a modified Cleveland Clinic Incontinence Score
Timeframe: 6 month
Safety will be demonstrated through an analysis of morbidity and complication rates associated with Durasphere.
Timeframe: Throughout study
The proportion of patients maintaining a 25% improvement in Cleveland Clinic Incontinence Score
Timeframe: 12 month