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)
ID Number 12-0736Principal Investigator(s)
Department(s) or Division(s)
"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)" will evaluate the long term safety and effectiveness of an injectable gel, known as Solesta®, for the treatment of fecal incontinence (FI). Solesta® has been approved by the Food and Drug Administration (FDA) for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (for example: diet, fiber therapy, medications that treat diarrhea).
Fecal Incontinence (FI) is an involuntary bowel movement that causes uncontrolled loss of solid or liquid waste from the anus. Many people in the United States are affected by FI. FI may result from damage to the muscles or nerves in the anus. The damage sometimes occurs in woman during delivery of a baby or it could be from spinal cord injury as well as other injuries. Sometimes the causes of FI are unknown.
Participation in the study is expected to last a period of 3 years with approximately 8 clinic visits. The participant will receive either one or two treatments (as deemed appropriate by your physician) of the gel throughout this timeframe as well as periodic physical examinations including a rectum and anal examination.
Recruiting Patients: Yes