A new research study for the treatment of fecal incontinence, in women, is available for females who qualify. TRANSFORM is being conducted in the U.S. to research a device that is designed to treat fecal incontinence.
Explore the links below to learn more about this clinical trial.
- What is a clinical trial?
- What is the TRANSFORM study exactly?
- Who can participate in the TRANSFORM study?
- What does participating in this study involve?
- How do I apply to participate?
The TRANSFORM study is a clinical trial taking place in the U.S. to evaluate the effectiveness of the TOPAS Sling System for the treatment of fecal incontinence in women.
The TOPAS Sling System is a small piece of mesh placed behind the anus through small incisions during a minimally invasive surgical procedure. The mesh creates a sling to give extra support to muscle that has been damaged or weakened.
The TRANSFORM Study is open to women over 18 years of age who have been diagnosed with moderate to severe fecal incontinence (2 or more accidents per week) and have had the condition for more than 6 months.
If you have accidental loss of stool and have not been successful with conservative treatments prescribed by your health professional, such as changes in diet, medications, and pelvic floor exercises, then you may wish to discuss the TRANSFORM study with your doctor.
This study will require you to have a thorough medical assessment prior to any treatment, and you will be asked to comply with the follow-up visit schedule for up to a period of three years, post-surgery.
You will be required to come back for a doctor visit at 14 days, 3 months, 6 months, 12 months, 2 years and 3 years after the procedure. Committing to attending each visit is important to monitor how you are doing.
You will not be able to participate in the study if you have certain pre-existing conditions such as chronic diarrhea, Crohn’s disease, and others, so you are encouraged to contact the medical center nearest you listed below to see if you might qualify. This study is also not open to anyone who is pregnant or planning on becoming pregnant in the future.
- Make sure you are eligible for the study:
- You are over 18 years of age
- You have two or more accidents per week
- You have been diagnosed with fecal incontinence six or more months ago
- You have already tried and failed other available options
- You can not participate if you:
- Are pregnant or planning a future pregnancy
- Have had a baby in the previous 12 months
- Have had pelvic surgery in the last 3-12 months
- Have an Inflammatory Bowel Disease such as Crohn's Disease
- Have chronic, watery diarrhea, unmanageable by drugs or diet, as a primary cause of fecal incontinence
- Have an active pelvic infection or fistula
- Have a condition that would compromise the surgery or wound healing
- Below are two medical centers that are offering this study. Click on the center closest to you to fill out an application. Please check back often. Medical Centers around the country are currently working to get approval to offer this study.
- Athens Women's Clinic - Athens, GA
- Raybon OB-GYN - Taccoa, GA
- St. Luke's Hospital - Allentown, PA
- University of North Carolina - Chapel Hill, NC
- University of California San Francisco - San Francisco, CA
- Atlantic Health System - Morristown, NJ
- Colorectal Surgical Associates - Houston, TX
- University of Michigan - Ann Arbor, MI
- The Lindner Center for Research and Education at Christ Hospital, West Chester, OH