Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence.
ABSTRACT Treatment options for patients with fecal incontinence (FI) are limited, and surgical treatments can be associated with high rates of infection and other complications. One treatment, sacral nerve stimulation (SNS), is approved for FI in Europe. A large multicenter trial was conducted in North America and Australia to assess the efficacy of SNS in patients with chronic fecal incontinence. The aim of this report was to analyze the infectious complication rates in that trial.
Adult patients with a history of chronic fecal incontinence were enrolled into this study. Those patients who fulfilled study inclusion/exclusion criteria and demonstrated greater than two FI episodes per week underwent a 2-week test phase of SNS. Patients who showed a > or = 50% reduction in incontinent episodes and/or days per week underwent chronic stimulator implantation. Adverse events were reported to the sponsor by investigators at each study site and then coded. All events coded as implant site infection were included in this analysis.
One hundred twenty subjects (92% female, 60.5 +/- 12.5 years old) received a chronically implanted InterStim Therapy device (Medtronic, Minneapolis, MN, USA). Patients were followed for an average of 28 months (range 2.2-69.5). Thirteen of the 120 implanted subjects (10.8%) reported infection after the chronic system implant. One infection spontaneously resolved and five were successfully treated with antibiotics. Seven infections (5.8%) required surgical intervention, with infections in six patients requiring full permanent device explantation. The duration of the test stimulation implant procedure was similar between the infected group (74 min) and the non-infected group (74 min). The average duration of the chronic neurostimulator implant procedure was also similar between the infected (39 min) and non-infected group (37 min). Nine infections occurred within a month of chronic system implant and the remaining four infections occurred more than a year from implantation. While the majority (7/9) of the early infections was successfully treated with observation, antibiotics, or system replacement, all four of the late infections resulted in permanent system explantation.
SNS for FI resulted in a relatively low infection rate. This finding is especially important because the only other Food and Drug Administration-approved treatment for end-stage FI, the artificial bowel sphincter, reports a much higher rate. Combined with its published high therapeutic success rate, this treatment has a positive risk/benefit profile.
- [show abstract] [hide abstract]
ABSTRACT: A 53-year-old otherwise healthy woman presents with a 2-year history of intermittent fecal incontinence. Because of embarrassment, she has curtailed her social and profes- sional activities. Physical activity often precipitates an episode, and she wears absor- bent pads. She has occasional urinary incontinence when she coughs or sneezes. There is no history of gastrointestinal or rectal surgery and no neurologic symptoms. Phys- ical examination reveals no perianal deformity or rectal prolapse. The tone of the anal canal is adequate, whereas contractions of the anal sphincter muscle and the puborec- talis muscle are weak. On the patient's bearing down, there is no rectal prolapse, and the perineal descent is approximately 2 cm. How should she be evaluated and treated? T h e C l i nic a l Probl e m Fecal incontinence is a devastating nonfatal illness, resulting in considerable embar- rassment and anxiety in those who have it. It affects 2 to 17% of people living in the community and almost half of all nursing home residents.1 Many affected persons do not voluntarily report fecal incontinence to their physicians and must be asked about it directly.2 The prevalence of fecal incontinence is increased among women, the elderly, per- sons with poor health status or physical limitations, and those residing in nursing homes.2 Other risk factors associated with fecal incontinence in adults include rectal radiation therapy (e.g., for prostate cancer), pregnancy, injury to the sphincter or nerve damage associated with vaginal delivery, anorectal surgical procedures (e.g., sphinc- terotomy for anal fissures), diarrhea alone or in association with the irritable bowel syndrome, and fecal impaction. Neurologic conditions (e.g., stroke, multiple sclerosis, spinal cord injury, and Parkinson's disease) and diabetes are also risk factors. Continence relies on the appropriate functioning of the puborectalis muscle and the internal and external anal sphincter muscles, which encircle the anal canal (Fig. 1). Factors such as stool consistency, rectal and colonic storage capacity, perception of rectal sensation, and cognitive and behavioral functioning also play important roles. An abnormality in any of these factors may result in fecal incontinence.New England Journal of Medicine 05/2007; 356(16):1648-55. · 51.66 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: Although surgery for fecal incontinence has been shown to be effective, it is still very challenging and sometimes frustrating. Overlapping sphincteroplasty, by far the most common procedure, is effective in patients with sphincter defects; however, recent data suggest that success rates tend to deteriorate over time. A thorough preoperative evaluation incorporates numerous factors, including patient characteristics, severity of incontinence, type and size of the sphincter defect as assessed by physical examination, anal ultrasound, and anorectal physiology studies including anal manometry, electromyography, and pudendal nerve terminal motor latency assessment. The use of these evaluation methods has allowed better patient assignment for a variety of new alternative treatment options. Innovations in the surgical treatment of fecal incontinence range from simple, office-based sphincter augmentation techniques to surgical implantation of mechanical devices. This article reviews 5 alternative surgical treatment options for fecal incontinence: injection of carbon-coated beads in the submucosa of the anal canal, radiofrequency energy delivery, stimulated graciloplasty, artificial bowel sphincter, and sacral nerve stimulation.Surgical Innovation 04/2005; 12(1):7-21. · 1.54 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: Fecal incontinence is a challenging condition of diverse etiology and devastating psychosocial impact. Multiple mechanisms may be involved in its pathophysiology, such as altered stool consistency and delivery of contents to the rectum, abnormal rectal capacity or compliance, decreased anorectal sensation, and pelvic floor or anal sphincter dysfunction. A detailed clinical history and physical examination are essential. Anorectal manometry, pudendal nerve latency studies, and electromyography are part of the standard primary evaluation. The evaluation of idiopathic fecal incontinence may require tests such as cinedefecography, spinal latencies, and anal mucosal electrosensitivity. These tests permit both objective assessment and focused therapy. Appropriate treatment options include biofeedback and sphincteroplasty. Biofeedback has resulted in 90 percent reduction in episodes of incontinence in over 60 percent of patients. Overlapping anterior sphincteroplasty has been associated with good to excellent results in 70 to 90 percent of patients. The common denominator between the medical and surgical treatment groups is the necessity of pretreatment physiologic assessment. It is the results of these tests that permit optimal therapeutic assignment. For example, pudendal nerve terminal motor latencies (PNTML) are the most important predictor factor of functional outcome. However, even the most experienced examiner's digit cannot assess PNTML. In the absence of pudendal neuropathy, sphincteroplasty is an excellent option. If neuropathy exists, however, then postanal or total pelvic floor repair remain viable surgical options for the treatment of idiopathic fecal incontinence. In the absence of an adequate sphincter muscle, encirclement procedures using synthetic materials or muscle transfer techniques might be considered. Implantation of a stimulating electrode into the gracilis neosphincter and artificial sphincter implantation are other valid alternatives. The final therapeutic option is fecal diversion. This article reviews the current status of the etiology and incidence of incontinence as well as the evaluation and treatment of this disabling condition.Diseases of the Colon & Rectum 02/1993; 36(1):77-97. · 3.34 Impact Factor