1010 Infection Rates in a Large Investigational Trial of Sacral Nerve Stimulation for Fecal Incontinence
Department of Colorectal Surgery, Cleveland Clinic Florida, Fort Lauderdale, FL, USA. Journal of Gastrointestinal Surgery
(Impact Factor: 2.8).
03/2010; 14(7):1081-9. DOI: 10.1007/s11605-010-1177-z
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.
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- "In all 5 cases, conservative management with antibiotics failed, and the patients required surgical removal of the infected device and its associated components. Another article published in the Journal of Gastrointestinal Surgery in 2010 reported on infection rates of SNS placed for fecal incontinence . Thirteen patients (10.8%) had an implant site infection. "
Available from: Manoj Raval
- "New surgical alternatives to overlapping sphincteroplasty such as sacral nerve stimulation (SNS) [15–17], Secca's procedure [18–20], artificial bowel sphincter (ABS) [21–23], and dynamic graciloplasty [24–26] have been developed and are increasingly used in the treatment of FI . "
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ABSTRACT: Fecal incontinence (FI) is the involuntary loss of rectal contents through the anal canal. Reports of its prevalence vary from 1-21%. Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents. This study evaluated the safety and efficacy of NASHA/Dx gel in the treatment of FI. One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA/Dx gel. Primary efficacy was based on data from 86 patients that completed the study. This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months. Significant improvements (P < .001) were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains. The majority of the treatment related AEs (94.9%) were mild or moderate intensity, and (98.7%) of AEs resolved spontaneously, or following treatment, without sequelae. Results of this study indicate NASHA/Dx gel was efficacious in the treatment of FI. Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment.
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ABSTRACT: This paper presents a variable reactance-type static VAr
compensator (SVC) which employs force-commutated switches as well as
thyristors. The proposed compensator employs thyristor switched
capacitors (TSC) and a fixed capacitor bank to control, in steps, the
amount of reactive power generated. Fine adjustment of the reactive
power generated and also the reactive power absorbed by the SVC are
obtained with N modules of a new four-switch (force-commutated) PWM
controllable reactor. These are controlled with phase shifted carriers
in order to achieve harmonic cancellation. The features of this
multi-module PWM SVC are analyzed using switching functions and
confirmed with simulation results
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