Study Overview: This study is testing a new treatment called iltamiocel for women who have trouble controlling bowel movements, known as chronic fecal incontinence. Chronic means it has been happening for at least 6 months. The study compares a single injection of iltamiocel to a placebo (a substance with no active medicine) to see which works better.
Participants: Women in this study have had an obstetric anal sphincter injury, which can happen during childbirth. The study is double-blind, meaning neither the participants nor the doctors know who gets iltamiocel or the placebo. Those who receive the placebo can choose to get the real injection after 12 months.
- Study Length: 12 months, with an option for further treatment.
- Eligibility: Adult females with certain childbirth injuries and long-term incontinence.
- Risks/Compensation: Participation includes a medical procedure with potential risks and benefits. Discuss details with your doctor.
Women interested in joining must meet specific health criteria and cannot have certain other conditions, such as recent childbirth injuries, obesity, or certain bowel diseases.