Do you have chronic fecal incontinence, also known as bowel leakage, and a history of obstetric anal injury?
Do you have chronic fecal incontinence and a history of obstetric anal injury?
The DigniFI Study is evaluating the effectiveness and safety of a single dose of an investigational product, iltamiocel, compared to a placebo for the potential treatment of bowel leakage, known as fecal incontinence, after childbirth.
You may qualify for this study if you:
Are a woman, 18 years of age and older.
Have been suffering from recurrent unintended passage of mucus and/or liquid or solid stool at least twice a week in a four-week period in the last 12 months.
Have a history of an obstetric anal sphincter injury.
Have tried conservative measures (such as dietary modifications, anti-diarrheal medications, pelvic floor muscle training and/or biofeedback) with no success for the past 6 months.
Study participation may last approximately 2 years, including the screening and follow-up periods, and may consist of up to 9 visits.
Qualified study participants may be reimbursed for travel expenses incurred for each completed study visit.
Complete this form to see if you prequalify for the DigniFI Study