A Randomized, Blinded, Multicenter Study to Evaluate NASHA/Dx for the Treatment of 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 (IBD).
• •Immunodeficiency or receiving immunosuppressive therapy.
• •Malignancies in remission for less than 2 years prior to the study.
• •Bleeding disorders or receiving anticoagulant therapy.
• •Chemotherapy within the last 12 months prior to the study.
• •Prior Pelvic radiotherapy.
• •Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
• •Women within one year post partum.
• •Participation in any other clinical study within 3 month prior to the study.
• •Hypersensitivity to hyaluronic acid containing products.
• •Other severe conditions or in other ways unsuitable to participate according to investigator judgement.