Sacral nerve modulation and other treatments in patients with faecal incontinence after unsuccessful pelvic floor rehabilitation: a prospective study.

Abstract Objectives Sacral Nerve Modulation is a minimally invasive technique for the treatment of faecal incontinence. This study investigates the results of sacral nerve modulation after negative outcome of a standardized pelvic floor rehabilitation program for the treatment of faecal incontinence. Patients and methods A prospective cohort study was performed between December 2001 and August 2007. Consecutive patients who visited the outpatient department for faecal incontinence were included in a multicentre study and treated with standardized pelvic floor rehabilitation. Those with an unsuccessful result who were eligible for sacral nerve modulation were included in the present study. Failures at test stimulation or sacral nerve modulation received another treatment. Clinical outcome, Vaizey scores and quality of life (EQ-5D and HAQL) were assessed during follow-up in patients with sacral nerve modulation and in patients with other treatments. Adverse events were documented. Results Thirty-five patients (mean age 59.7 years; 31 females) were included. Twenty-one had a successful test stimulation and 19 patients proceeded to a sacral nerve modulation implant. Incontinence episodes per week decreased significantly from 11.1+/-11.7 to 1.9+/-2.6 during test stimulation (p<0.0001) and sacral nerve modulation over 24.1 months follow-up. The overall success rate was 49% (17/35). The patients with unsuccessful test stimulation or sacral nerve modulation received other treatments. The Vaizey score improved in both sacral nerve modulation (18.2+/-3.5 vs. 13.7+/-4.8; p=0.004) and other treatment (18.2+/-3.5 vs. 13.9+/-6.9; p=0.019). The HAQL scale improved significantly during sacral nerve modulation in all subscales (p<0.005), but not in the other treatment group. Eight adverse events occurred during test stimulation (23%) and six adverse events after permanent implantation (26%). Conclusion sacral nerve modulation improves disease specific quality of life significantly compared to other treatment.