ABSTRACT
BACKGROUND: Limited data have been published regarding the long-term results of sacral nerve stimulation, or sacral neuromodulation, for severe fecal incontinence. OBJECTIVES: The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed. DESIGN: Patients entered in a multicenter, prospective study for fecal incontinence were followed at 3, 6, and 12 months and annually after device implantation. PATIENTS: Patients with chronic fecal incontinence in whom conservative treatments had failed or who were not candidates for more conservative treatments were selected. INTERVENTIONS: Patients with ≥ 50% improvement over baseline in fecal incontinence episodes per week during a 14-day test stimulation period received sacral nerve stimulation therapy. MAIN OUTCOME MEASURES: Patients were assessed with a 14-day bowel diary and Fecal Incontinence Quality of Life and Fecal Incontinence Severity Index questionnaires. Therapeutic success was defined as ≥ 50% improvement over baseline in fecal incontinence episodes per week. All adverse events were collected. RESULTS: A total of 120 patients (110 women; mean age, 60.5 years) underwent implantation. Seventy-six of these patients (63%) were followed a minimum of 5 years (maximum, longer than 8 years) and are the basis for this report. Fecal incontinence episodes per week decreased from a mean of 9.1 at baseline to 1.7 at 5 years, with 89% (n = 64/72) having ≥ 50% improvement (p < 0.0001) and 36% (n = 26/72) having complete continence. Fecal Incontinence Quality of Life scores also significantly improved for all 4 scales between baseline and 5 years (n = 70; p < 0.0001). Twenty-seven of the 76 (35.5%) patients required a device revision, replacement, or explant. CONCLUSIONS: The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and beyond. Device revision, replacement, or explant rate was acceptable, but future efforts should be aimed at improvement.
Subject(s)
Electric Stimulation Therapy/instrumentation , Fecal Incontinence/therapy , Sacrum/innervation , Anal Canal/innervation , Chronic Disease , Electric Stimulation Therapy/methods , Electrodes, Implanted , Female , Follow-Up Studies , Humans , Male , Quality of Life , Surveys and Questionnaires , Treatment OutcomeABSTRACT
OBJECTIVE: The aim of the present analysis was to report on the relationship between long-term improvement in quality of life (QOL) and fecal incontinence (FI) severity and long-term reduction in FI episodes after sacral nerve stimulation (SNS) or sacral neuromodulation. METHODS: Patients who met inclusion/exclusion criteria, and initially had more than 2 FI episodes per week, were offered SNS therapy. Patients with 50% or higher reduction in FI during a 2-week test period were implanted with a neurostimulator (InterStim; Medtronic, Minneapolis, Minn). Assessments were completed by patients at baseline and at 3, 6, and 12 months after implant, and annually thereafter. The present report includes data from the 4-year postimplant follow-up. RESULTS: A total of 133 patients underwent test stimulation with a 90% success rate, and as a result, 120 (110 females) with a mean age of 60.5 years and a mean duration of FI of 6.8 years received long-term implantation. Of them, 78 patients completed all or part of the 4-year follow-up assessment. Fecal incontinence episodes decreased from a mean of 9.4 per week at baseline to 1.9 per week at 48 months (P < 0.001). The 4-year analyses showed that SNS had a positive and sustained impact on all 4 scales of the Fecal Incontinence Quality of Life questionnaire (P < 0.001), Fecal Incontinence Severity Index scores improved from a mean of 39.9 to 28 (P < 0.001), and self-rated bowel health scores improved from a mean of 3.5 to 6.9 (P < 0.001). CONCLUSIONS: Sacral nerve stimulation not only restores or improves continence in treated patients with chronic FI but also improves their quality of life and symptom severity.
Subject(s)
Anal Canal/innervation , Electric Stimulation Therapy , Electrodes, Implanted , Fecal Incontinence/therapy , Lumbosacral Plexus , Quality of Life , Adult , Aged , Aged, 80 and over , Anal Canal/physiopathology , Diagnostic Self Evaluation , Electric Stimulation Therapy/instrumentation , Electric Stimulation Therapy/methods , Fecal Incontinence/diagnosis , Fecal Incontinence/physiopathology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Self Report , Severity of Illness Index , Time , Treatment OutcomeABSTRACT
BACKGROUND: The use of DDIR mode has been limited since the advent of mode switch in the DDDR mode. In patients with AV block, DDDR is necessary to maintain AV synchrony. However, DDIR mode may still be beneficial for patients with intact AV conduction. The aim of this study was to compare the incidence of ventricular pacing and atrial tachyarrhythmia in DDIR and DDDR with mode switch in a randomized, single-blind, crossover study, and discuss the utility of both modes. METHODS AND RESULTS: Twenty-four patients (8 males) with bradycardia-tachycardia syndrome and no signs of AV block (mean age 70.1 +/- -9.1 years) were enrolled and randomized to DDIR or DDDR modes with the leads placed at the right atrial appendage and right ventricular apex. After 12 weeks, patients were switched to the opposite mode. During the study period, atrial high rate episodes and other pacemaker diagnostic data were collected. Significantly less ventricular pacing was observed in DDIR mode (DDIR versus DDDR; 48.9%, 76.5%, P = 0.0002) and atrial high rate episodes were significantly lower in DDIR mode (DDIR versus DDDR; 1.32, 1.85 per day, P < 0.05). CONCLUSION: In patients with sinus node dysfunction and intact AV conduction, DDIR mode may have important implications for simplifying device programming, device longevity, and to avoid atrial tachyarrhythmia.
