Researcher Discusses TOPAS Mesh System For Patients Suffering From Accidental Bowel Leakage

Dr. Dee Fenner, M.D. Professor of Obstetrics and Gynecology Director of Gynecology University of Michigan MedicalResearch.com Interview with:
Dr. Dee Fenner, M.D.
Professor of Obstetrics and Gynecology
Director of Gynecology
University of Michigan

MedicalResearch.com Editor’s note: American Medical Systems Inc. (AMS), a subsidiary of Endo International plc (Nasdaq: ENDP) (TSX: ENL), released top-line results from its TRANSFORM study that show the investigational TOPAS™ System improves fecal incontinence in women.

The results show that over a 12 month period, 69% of women suffering from fecal incontinence who were implanted with the TOPAS™ System experienced at least a 50% reduction in weekly incontinence episodes and experienced a durable, consistent effect across the study period. The results were presented in Cape Town, South Africa at the International Society of University Colon & Rectal Surgeon (ISUCRS) Congress.

Dr. Fenner, a primary investigator of the study, kindly answered the questions below:

Medical Research: How common/prevalent is the problem of fecal incontinence in women?

Dr. Fenner: Fecal incontinence, also known as accidental bowel leakage (ABL), is estimated to affect nearly 11 million women and 10% of women over the age of 20 in the United States.1,2 Additionally, nearly one in five women over the age of 45 experience ABL at least once a year.3


Medical Research: What medical/surgical conditions contribute to this incidence?

Dr. Fenner: Contributing factors to the development of accidental bowel leakage may include childbirth, trauma, obesity, diabetes, multiple sclerosis and inflammatory bowel disease. Patients may have one or several of these factors and sometimes it is difficult to identify which one is most important. ABL is most commonly associated with damage to the pelvic floor muscles caused during childbirth.

Medical Research: Can you describe the TOPAS™ System and how it aids in reducing fecal incontinence? Are there side effects associated with this new procedure?

Dr. Fenner: The TOPAS™ System supports a woman’s natural anatomy and is designed for use when conservative therapies like dietary changes, anti-diarrheal medicine and pelvic floor muscle training are not effective. It is a permanently implanted mesh strip designed to naturally support and maintain pelvic floor muscles. The strip of surgical mesh is passed between two incisions, beneath the puborectalis muscle (not inside the anal canal) and each end of the mesh is then pulled up through corresponding thigh incisions using specially designed instruments. The mesh is then adjusted to the proper tension. Top-line data showed the TOPAS™ System provided an early and durable decline in the number of accidental bowel leakage episodes and has a favorable safety profile.

The procedure typically takes about 30 minutes and patients usually can return home on the same day. After the procedure patients are advised to abstain from heavy lifting, exercise and intercourse for a minimum of six weeks, which is typical for other urogynecologic surgical procedures.

The most common side effects observed in the TRANSFORM study (>5%) were pain (primarily buttock, pelvic or groin pain) and incision site infection. In the TRANSFORM study no patients experienced erosions, extrusions, organ perforations, bowel obstructions, or device revisions but these are potential risks any time a mesh is implanted and it is important that they are discussed with the patient.

Medical Research: What further research do you plan regarding fecal incontinence and the TOPAS™ System in particular?

Dr. Fenner: The TRANSFORM study will continue to follow patients for up to five years to fully understand the long-term patient outcomes and the impact of the TOPAS™ System on accidental bowel leakage. AMS will be conducting post-market studies that will be either part of their approval requirements or will be studies that AMS elects to conduct to evaluate safety and efficacy in a broader base of implanters.

Future data releases will include additional endpoints and details that were collected as part of TRANSFORM.

References:

  1. S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2012. Internet release date Dec 2013
  2. Wu JM, Vaughan CP et al, Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014; 123(1):141–148). DOI: 10.1097/AOG.0000000000000057
  3. Manchio JV, Sanders BM, Fecal incontinence: Help for patients who suffer silently. J of Family Practice. 2013; 62(11):640-650