Are you suffering from female-related fecal incontinence?

If so, Dr. Leslie Roth, MD, FACS, FASCRS at Brown Surgical Associates is conducting two ongoing studies that may be suitable for you. 

For more information or to determine your eligibility for these studies, please contact the research team using the details provided below.

Contact Information:

• Research Nurse Contact: Melanie Salerno
  • Phone: (401) 450-2507
  • Email: melanie.salerno@brownphysicians.org

DigniFI:  Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females with Obstetric Injury

Overview:

The DigniFI Study evaluates the effectiveness and safety of a single dose of an investigational product, iltamiocel, compared to a placebo for treating bowel leakage (fecal incontinence) following childbirth.

Eligibility Criteria:

• Female, 18 years of age or older
• Suffering from recurrent unintended passage of mucus and/or liquid or solid stool at least twice a week over a four-week period in the last 12 months
• History of an obstetric anal sphincter injury
• Unsuccessful with conservative measures (e.g., dietary modifications, anti-diarrheal medications, pelvic floor muscle training, and/or biofeedback) for the past 6 months

Study Details:

• Duration: Approximately 2 years, including screening and follow-up periods
• Visits: Up to 9 study-related visits
• Compensation: Qualified participants may be reimbursed for travel expenses incurred for each completed study visit