Sacral neuromodulation as an effective treatment for refractory pelvic floor dysfunction

Abstract

Objectives. To determine the long-term efficacy and complications of sacral nerve stimulation as an alternative therapy for pelvic floor dysfunction. Pelvic floor dysfunction is a complex problem that can be refractory to current treatment modalities. Conservative therapy rarely results in a durable cure of patients, and various surgical procedures have significant side effects and less than optimal results. Methods. Sixty-four patients, 54 women and 10 men, with various forms of voiding dysfunction for whom other forms of therapy had failed underwent placement of the Medtronic Implantable Pulse Generator sacral nerve implant. The mean age was 47 years. The presenting complaint was frequency, urgency, and urge incontinence in 44 patients and chronic nonobstructive urinary retention requiring self-catheterization in 20 patients. Forty-one patients also had chronic pelvic and perineal pain associated with their voiding symptoms. The mean duration of symptoms was 69 months. All patients underwent percutaneous nerve evaluation before the permanent implant and demonstrated more than 50% improvement in their symptoms. All patients were evaluated at 1, 3, 6, 12, and 24 months, and yearly thereafter. The assessment of the voiding symptoms was done both subjectively by patient symptoms and objectively using voiding diaries recorded for 3 days. A validated verbal rating pain scale was used to evaluate pain levels. Results. Eighty percent of the patients had 50% or greater improvement in their presenting symptoms and quality of life after the procedure, with a mean follow-up of 24 months. Patients with frequency-urgency showed a reduction in the number of voids per day with a significant increase in voided volumes. Patients with urge incontinence showed a reduction in leaking episodes from 6.4 to 2.0/24 hr, with a decrease in the number of pads used from 3.5 to 1.2/day. Sixteen of 20 patients with urinary retention were able to void with a residual volume of less than 100 mL. Patients with chronic pelvic pain showed a decrease in the severity of pain from a score of 5.8 to 3.7. Complications were minimal and encountered in 18.7% of the patients. Conclusions. Sacral nerve stimulation is an effective and durable new approach to pelvic floor dysfunction with minimal complications. Test stimulation provides a valuable tool for patient selection.