Dignifistudy -

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 63 weeks, 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

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Are you 18 years of age and older? *

Are you a female? *

Have you been suffering from bowel leakage accidents at least twice a week in a four-week period in the last 12 months? *

Do you have a history of anal sphincter injury due to a vaginal delivery? *

In the past 6 months, have you tried any of the following approaches with no success? *

Dietary modifications
Anti-diarrheal medications
Bowel training
Biofeedback
None
Other

Other

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