Is sacral nerve stimulation an effective treatment for chronic idiopathic anal pain?

BACKGROUND: Chronic idiopathic anal pain is a common, benign symptom, the etiology of which remains unclear. Traditional treatments are often ineffective. This study investigated the efficacy of sacral nerve stimulation in treating chronic idiopathic anal pain. METHODS: Twelve patients (10 women and 2 men; mean age, 61.0 +/- 10.3 years; range, 48-82 years) implanted with a permanent device for sacral nerve stimulation were followed in the Italian Group for Sacral Neuromodulation (GINS) Registry. All patients had frequent chronic anal or perianal pain; 75 percent had previously undergone pelvic surgery. Pharmacologic and rehabilitative therapy had yielded poor results. Changes from baseline to last follow-up examination were evaluated for scores on a visual analog pain scale (0-10) and the Short-Form 36 (SF-36) health status questionnaire. Manometric measurements recorded at last follow-up were compared with preimplantation values. RESULTS: In one patient, the permanent device was removed because of technical failure. After a mean follow-up of 15 (range, 3-80) months, visual analog pain scores had significantly improved (from 8.2 +/- 1.7 to 2.2 +/- 1.3, P < 0.001). SF-36 physical component scores increased from 26.27 +/- 5.65 to 38.95 +/- 9.08, P < 0.02). Scores on the mental component showed improvement, although not significant. Postimplantation changes in manometric functional data were not significant, but sensitivity thresholds showed a considerable decrease. CONCLUSIONS: Long-term follow-up data showing improvements in scores on the visual analog pain scale and quality of life questionnaire indicate that, before adopting more aggressive surgical procedures, SNS should be considered for patients with chronic idiopathic anal pain in whom pharmacologic and biofeedback treatments have failed to produce effective results.

Long-term outcome of sacral nerve stimulation for fecal incontinence.

PURPOSE: Sacral nerve stimulation is a safe and effective procedure for fecal incontinence. We investigated whether its efficacy is maintained long term. PATIENTS AND METHODS: Sixty patients with fecal incontinence underwent permanent sacral nerve stimulation. Patients' data were prospectively recorded in the national registry of the Italian Group of sacral nerve stimulation. The severity of fecal incontinence was evaluated by the Wexner score, and data were collected in a bowel function diary. Quality of life was evaluated by the Italian version of the Medical Outcomes Survey Short Form (SF-36) questionnaire. RESULTS: Fifty-two patients were available for long-term follow-up lasting at least 5 years. Compared with baseline, the Wexner score decreased significantly after definitive implantation (from 15 +/- 4 to 5 +/- 5, P < 0.001). At least 50 percent improvement in continence was achieved in 74 percent of the patients, and at least 70 percent improvement (median value) was achieved in 50 percent. The mean number of solid/liquid incontinence episodes decreased significantly from 0.5 (+/-0.5) to 0.1 (+/-0.3) per day (P = 0.004). Quality of life improved in all domains. The overall mean improvement in SF-36 scores was 39.8 percent. Both mean resting and squeeze anal pressures increased significantly, and maximum volume tolerated decreased significantly. CONCLUSIONS: Sacral nerve stimulation maintains its efficacy long term, not only in regard to control of symptoms but also regarding quality of life.

Do geographic and educational factors influence the quality of life in rectal cancer patients with a permanent colostomy?

PURPOSE: This study was designed to evaluate possible social and geographic factors that could have an impact on quality of life in patients after abdominoperineal excision of the rectum. Although the number of patients with rectal cancer who need to be treated with abdominoperineal excision of the rectum and construction of permanent colostomy has greatly decreased in the past, there is still controversy about the influence on quality of life caused by this procedure. METHODS: In a prospective trial, patients operated on for low rectal cancer by abdominoperineal excision of the rectum were evaluated by a quality of life questionnaire, modified from The American Society of Colon and Rectal Surgeons questionnaire, to assess fecal incontinence. The results for the four domains of quality of life (lifestyle, coping behavior, embarrassment, depression), as well as for subjective general health, were evaluated with regard to age, gender, education, and geographic origin in univariate and multivariate analyses. RESULTS: Thirteen institutions in 11 countries included data from 257 patients. Although the analysis of general health did not reveal any significant differences, the analysis of the four quality of life domains showed the significant influence of geographic origin. The presence of a permanent colostomy showed a consistently negative impact on patients in southern Europe as well as for patients of Arabic (Islamic) origin. On the other hand, age, gender, and educational status did not reveal a statistically significant influence. CONCLUSIONS: This is the first study to show the influence of geographic origin on quality of life of patients with a permanent colostomy. Possible factors that may influence the outcome of patients after surgical treatment of rectal cancer, such as weather, religion, or culture, should be taken into account when quality of life evaluations are considered.

[Italian translation and prospective validation of fecal incontinence quality of life (FIQL) index]. / Traduzione e validazione prospettica della versione italiana del Fecal Incontinence Quality Of Life (FIQL) index.

The evaluation of any functional disease affecting quality of life requires a purpose-designed quality-of-life index for clinical trials as well as for evaluating the outcomes of treatments. The fecal incontinence quality of life index (FIQL) was developed at Minnesota University (USA) for patients with faecal incontinence but could not be used for Italian patients without appropriate cultural and linguistic adaptation. Therefore this index was translated into italian and prospectively validated on a new series of 73 incontinent patients and 8 healthy controls in order to provide Italian coloproctologists with a useful tool for clinical research. The italian version or the FIQL index met all the statistical criteria of reliability, reproducibility, specificity and convergency required and therefore can be used with confidence in clinical trials on such patients.

Reliability of electrophysiologic anal tests in predicting the outcome of sacral nerve modulation for fecal incontinence.

INTRODUCTION: Sacral nerve modulation has been demonstrated to be a new efficacious treatment for fecal incontinence. The effectiveness of the procedure is preliminarily tested by means of a peripheral nerve evaluation. Integrity of the sacral neural pathway is generally believed to be a necessary condition for a good response, but no data are available to confirm whether electrophysiologic anal tests are predictive of the clinical outcome of the peripheral nerve evaluation. METHODS: Eighty-two incontinent patients underwent the peripheral nerve evaluation after full evaluation of the anorectal physiology. Univariate analysis was performed, and the positive predictive value, sensitivity, and specificity were calculated for each of the tests. RESULTS: Forty-six patients had successful results to the peripheral nerve evaluation and were subjected to permanent implant of a sacral electrostimulator. Anal sphincter electromyography had been performed in 60 patients, whereas pudendal nerve terminal motor latency had been assessed in 68 and evoked sacral potentials in 29 patients. Anal electromyography was statistically related to the outcome of the peripheral nerve evaluation ( P = 0.0004) with a positive predictive value of 81 percent, a sensitivity of 44 percent, and a specificity of 81 percent. Pudendal nerve terminal motor latency on the right side did not correlate with the outcome, but left pudendal nerve terminal motor latency was weakly correlated ( P = 0.02), although both tests had a low positive predicting value and sensitivity vs. good specificity. Evoked sacral potentials did not correlate with the outcome and had a low positive predictive value, sensitivity, and specificity. CONCLUSIONS: Simple anal sphincter electromyography can predict the outcome of the peripheral nerve evaluation with good positive predictive value and specificity in patients with fecal incontinence. Other, more expensive, electrophysiologic anal tests do not add further prognostic information.