ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.
Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.
The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.
From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.
The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.
Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.
Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.
In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.
“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.
The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.
The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.
Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.