Clinical Trials

Inclusion Criteria:

A patient will be eligible for study participation if he/she meets the following criteria:

• Able to fluently speak and understand the language in which the study is being conducted and able to provide meaningful written informed consent for the study.
• Have FI, have failed conservative therapy (e.g., diet, fiber therapy, medications that treat diarrhea), and are scheduled to receive Solesta treatment.
• Females must be of non-childbearing potential; or females of childbearing (reproductive) potential must agree to use an acceptable method of contraception for at least the first 6 months of study participation and have a negative urine pregnancy test at Visit 1 (Screening/Baseline) and immediately prior to receiving initial Solesta treatment. Women who are surgically sterile or those who are post menopausal for at least 2 years prior to entering the study are not considered to be of childbearing potential.
• Willing to return to the study facility for the post treatment evaluation.

Exclusion Criteria:

A patient will be excluded from the study if he/she meets any of the following criteria:

• Is currently pregnant, breastfeeding, or is planning to become pregnant over the course of the study.
• Has an active inflammatory bowel disease.
• Has an immunodeficiency disorder or ongoing immunosuppressive therapy.
• Has received previous radiation treatment to the pelvic area.
• Has significant mucosal or full thickness rectal prolapse.
• Has active anorectal conditions including: abscess, fissures, sepsis, bleeding, proctitis, or other infections.
• Has anorectal atresia, tumors, stenosis or malformation.
• Has a rectocele.
• Has rectal varices.
• Has presence of existing implant including Solesta, artificial bowel sphincter, or sacral nerve stimulator (activated or inactivated).
• Has an allergy to hyaluronic acid (HA) based products.
• Has an anastomosis to the rectum or anus within 10 cm of the dentate line.
• Has an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the requirements of the post-approval study protocol.
• Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
• Has undergone sphincteroplasty, graciloplasty, or other surgical interventions (without the use of an implanted device) for treatment of fecal incontinence within 12 months of enrollment.
• Has any bleeding disorder.