Study to Evaluate Solesta for Treatment of Fecal Incontinence

An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence

The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed treatment.

Inclusion Criteria:

• 18-80 years of age, male or female
• Screening fecal incontinence severity score (CCFIS)
• Fecal incontinence episodes over a 28-day period
• Failed conservative treatment for fecal incontinence

Exclusion Criteria:

• Complete external sphincter disruption
• Significant anorectal disease
• Anorectal surgery within the last 12 months prior to the study
• Active Inflammatory Bowel Disease
• Immunodeficiency or receiving immunosuppressive therapy
• Malignancies in remission for less than 1 years prior to the study
• Bleeding disorders or receiving anticoagulant therapy
• Chemotherapy within the last 6 months prior to the study
• Prior Pelvic radiotherapy
• Pregnant or breast-feeding women, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study
• Women within 6 months post partum
• Participation in any other clinical study within 3 month prior to the study
• Other severe conditions or in other ways unsuitable to participate according to investigator judgement