Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence

Inclusion criteria

• Onset of symptoms for uncontrolled passage of fecal material for at least 6 months prior to enrollment.
• At least 2-4 staining, solid or liquid FI episodes in the 4 weeks prior to enrollment
• Documented normal colonoscopy in the last 3 years
• Normal sigmoidoscopy as part of screening
• Signed consent

Exclusion criteria

• Pregnant or breastfeeding women
• Rectal prolapse grade ≥ III
• Hemorrhoids Grade ≥ II.
• Obstetrical injuries including third- and fourth-degree tears in the anal sphincter within the past 6 months
• Internal anal sphincter separation >270 degrees on Transrectal Ultrasound (TRUS).
• Congenital malformation of anus or rectum
• History of pelvic surgery in the past 6 months.
• inflammatory bowel disease.
• Presence of Intestinal stoma
• History of pelvic radiation within the previous 12 months or presence of active radiation proctitis.
• Presence of existing implant in the anal or rectal region.
• Active anal or rectal conditions in the last 6 months
• Abnormal blood coagulation
• Patients currently receiving immunotherapy or chemotherapy.