BACKGROUND: Sacral nerve stimulation has a place in the treatment algorithm for fecal incontinence, but the predictive factors of its midterm and long-term success are unknown.
OBJECTIVE: The purpose of this study was to investigate the effect of a 3-year sacral nerve stimulation treatment of fecal continence and to identify specific predictive factors from the pretreatment and per-treatment assessments for the midterm success of sacral nerve stimulation.
DESIGN: A cohort analysis of consecutive patients treated with sacral nerve stimulation for fecal incontinence over a period of 3 years was performed.
SETTINGS: This study was conducted at an academic colorectal unit in a tertiary care center.
PATIENTS: Sixty patients were available for the assessment of 3-year outcomes.
MAIN OUTCOME MEASURES: Clinical outcome (including Cleveland Clinic score) and anorectal physiological data were collected prospectively before and after treatment.
RESULTS: At the 3-year follow-up, 33 of the 60 implanted patients had an improved outcome as defined by a ≥30% improvement in the Cleveland Clinic score from baseline (37.1% on intention to treat and 55.0% per protocol), whereas 22 had an unsuccessful outcome as defined by a <30% improvement in the Cleveland Clinic score from baseline (24.7% on intention to treat and 36.7% per protocol), of whom 7 had their device explanted or switched off permanently before the 3-year assessment, and 3 were lost at follow-up. At 3 years, we failed to identify any factors that could predict the 3-year clinical outcome of sacral nerve stimulation based on preimplantation and postimplantation assessments.
LIMITATIONS: This study involved a relatively small number of patients. There was a lack of consistency in the tool used to evaluate the efficacy of the test and permanent stimulations.
CONCLUSIONS: Based on per-protocol assessments, 55% of the patients had improved outcomes at the 3-year follow-up. No predictor was identified by the pretreatment and posttreatment assessments (see Video, Supplemental Digital Content 1, http://links.lww.com/DCR/A133).
1Institut National de la Santé et de la Recherche Médicale U1073, Service de Physiologie Digestive, Centre Hospitalier Universitaire de Rouen, Institut National de la Santé et de la Recherche Médicale Centre d’Investigation Clinique 0204, Rouen, France
2Institut National de la Santé et de la Recherche Médicale U1073, Service de Chirurgie Digestive, Centre Hospitalier Universitaire de Rouen, Rouen, France
3Unité de Biostatistiques, Centre Hospitalier Universitaire de Rouen, Rouen, France
Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML and PDF versions of this article on the journal’s Web site (www.dcrjournal.com).
Funding/Support: Dr Leroi has received honoraria from Medtronic, Norgine, and Shire.
Financial Disclosure: None reported.
Correspondence: Anne-Marie Leroi, M.D., Ph.D., Service de Physiologie Digestive, Hôpital Charles Nicolle, 1 rue de Germont, 76031 Rouen Cedex, France. E-mail: email@example.com