Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

A Prospective, Single Arm, Multicenter, Observational Assessment of the Long Term Safety and Efficacy of Solesta® Injectable Bulking Agent for the Treatment of Fecal Incontinence (SoFI)

The purpose of this observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.

This observational study is to evaluate the safety and effectiveness of the Solesta Injectable Bulking Agent in the treatment of fecal incontinence through 3 years in a real world setting.

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.