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Sacral Spinal Nerve Stimulation Has Benefit for Treatment of Faecal Incontinence
Lancet
04/15/2004
By Joene Hendry
Sacral nerve stimulation can reduce episodes of incontinence and improve quality of life in patients with an intact or repaired anal sphincter, according to findings from a multicentre, prospective, non-randomised study.
"We have shown sustained improvement in multiple outcome variables in patients selected on the basis of subchronic stimulation," writes Professor Klaus E. Matzel, MD, Department of General Surgery, University Hospital Erlangen, Germany, and colleagues.
To test the efficacy of sacral nerve stimulation, the researchers enrolled 37 patients mean age of 54.3 years reporting faecal incontinence at least once weekly for a mean of 5.9 years. Patients had intact external anal sphincters and had failed refractory medical and biofeedback therapy.
Patients underwent a staged diagnostic screening procedure to establish the integrity of their sacral spinal nerves and to identify the optimal site of stimulation. Of these patients, 34 underwent implantation with a permanent neurostimulation device, while 3 patients received no implantation due to non-adherence during the screening period, repeat lead dislodgement or infection.
The frequency of incontinent episodes decreased from a mean of 16.4 per week prior to implantation to 3.1 per week at 12 months and to 2.0 per week at 24 months after implantation. Prior to implantation, patients reported a mean 4.5 days per week of incontinence, which fell to 1.4 days per week at 12 months and to 1.2 days per week 24 months after implantation. Post-transplantation reports of staining and pad use also decreased from baseline values. At least 37% of the patients achieved fully restored continence over a median follow up of 23.9 months.
Quality of life improved in all 4 scales of the American Society of Colon and Rectal Surgery Questionnaire (P = .0001), and patients reported improvement in 7 of 8 standard health survey scales (P = .0002).
Overall, 12 patients had 19 device-related adverse events, rated mild in 7, moderate in 4, and severe in 8 events. The most frequently reported complication was pain, reported in 24% of patients, which was resolved in all but 1 patient with reprogramming, medications or repositioning of the pulse generator. The resolution rate was 63.2% for all complications, but the authors note that all severe complications were completely resolved.
"With its low morbidity, sacral nerve stimulation is a safe and effective option for patients with an intact or repaired anal sphincter," the authors conclude. "When conventional treatment is inappropriate or ineffective, it should be considered before sphincter replacement or stoma creation."
Lancet 2004;363:1270-76.
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