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Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

Testing treatment for women with fecal incontinence after childbirth.

Recruiting
18 years and older
Female
Phase 3

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.

Study details
    Fecal Incontinence

NCT05776277

Cook MyoSite

13 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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