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A Preliminary Evaluation of the TOPAS System for the Treatment of Fecal Incontinence in Women

Rosenblatt, Peter MD; Schumacher, Joshua BA; Lucente, Vincent MD, MBA; McNevin, Shane MD; Rafferty, Janice MD; Mellgren, Anders MD, PhD

Female Pelvic Medicine & Reconstructive Surgery: May/June 2014 - Volume 20 - Issue 3 - p 155–162
doi: 10.1097/SPV.0000000000000080
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Objectives The TOPAS AMS pelvic floor repair system is a self-fixating polypropylene mesh intended for use to reinforce soft tissues where weakness exists in the gynecological and gastroenterological anatomy. It is not available commercially in any country. This was a preliminary study conducted to obtain initial clinical experience with the TOPAS system for the treatment of fecal incontinence (FI) in women.

Methods This was a prospective study conducted at 5 centers in the United States. Women with FI who failed 1 or more conservative therapies were candidates for the study. Fecal incontinence was assessed with a bowel diary, Cleveland Clinic incontinence scores (CCISs), and Fecal Incontinence Quality of Life (FIQOL) questionnaires, and patients were followed prospectively up to 24 months. Treatment success was defined as a reduction in number of FI episodes of 50% or more compared with baseline.

Results A total of 29 women (mean age, 60.6 years) were implanted with the TOPAS system. Mean number of FI episodes per 14 days decreased from 6.9 at baseline to 3.5 at 24 months of follow-up, and the reduction was significant for the entire follow-up period compared with baseline (P < 0.001). A total of 55.6% of the subjects reported treatment success. The CCIS and FIQOL scores for all domains were significantly improved during the overall follow-up period compared with baseline (P < 0.001). The most common procedure and/or device-related adverse events were de novo urinary incontinence, including bladder spasms (n = 6), worsening FI (n = 2), and constipation (n = 2). No device-related erosions or extrusions were reported.

Conclusions Initial experience of the TOPAS system demonstrated a significant improvement in FI episodes, CCIS and FIQOL scores, and a benign safety profile. These results indicate that the TOPAS system has potential as a new therapeutic option for FI, but it needs to be confirmed in a larger study.

Initial experience of the TOPAS system demonstrated a significant improvement in fecal incontinence episodes, quality of life scores, and a benign safety profile.

From the *Division of Urogynecology, Mount Auburn Hospital, Cambridge, MA; †American Medical Systems, Minnetonka, MN; ‡Institute for Female Pelvic Medicine & Reconstructive Surgery, Allentown, PA; §Sacred Heart Medical Center, Spokane, WA; ∥Division of Colon and Rectal Surgery, The Christ Hospital, Cincinnati, OH; and ¶Colon & Rectal Surgery Associates, Ltd, Minneapolis, MN.

Reprints: Peter Rosenblatt, MD, Division of Urogynecology, Mount Auburn Hospital, 725 Concord Ave, Suite 1200, Cambridge, MA 02138. E-mail: plrosen@comcast.net.

Conflicts of interest and source of funding: This study was sponsored by the American Medical Systems, Inc (AMS). Dr Rosenblatt has received honoraria for consulting from AMS, ETHICON, Boston Scientific, Medtronic, and Coloplast, is on the speaker’s bureau for ETHICON and Boston Scientific, and receives royalties from AMS and Cook Medical. Mr Schumacher is an employee and shareholder of AMS. Dr Lucente has received honoraria for consulting from AMS, Bard, Kimberly-Clark, Coloplast, and Medtronic and is on the speaker’s bureau for Allergan, AMS, Bard, and Coloplast. Dr Rafferty has received honoraria for consulting from AMS and ETHICON and is on the speaker’s bureau for LifeCell. Dr Mellgren’s institution has received research support from AMS, Medtronic, Salix Pharmaceuticals, Torax, Tsumura, and Uroplasty. Dr Mellgren has participated in educational activities for Medtronic and Salix Pharmaceuticals. For Dr McNevin, none were declared.

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