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Sacral Nerve Stimulation for Fecal Incontinence

How Long Should the Test Phase Be?

Lambrescak, Elsa, M.D.1; Wyart, Vincent, M.D.2; Meurette, Guillaume, M.D., Ph.D.2; Faucheron, Jean-Luc, M.D., Ph.D.3; Thomas, Christian, M.D.1; Atienza, Patrick, M.D.1; Lehur, Paul-Antoine, M.D., Ph.D.2; Etienney, Isabelle, M.D.1

doi: 10.1097/DCR.0000000000000942
Original Contributions: Pelvic Floor
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BACKGROUND: Decision-making for pulse generator implantation for sacral nerve stimulation in the management of fecal incontinence is based on the results of a test phase. Its duration is still a matter of debate.

OBJECTIVE: The purpose of this study was to determine whether an early positive response during the test phase could predict implantation of a permanent sacral nerve pulse generator.

DESIGN: This was a short-term observational cohort study. A positive response was defined as a >50% decrease of fecal leaks compared with baseline. A multivariate logistic regression was computed to predict pulse generator implantation after the first week of the test phase.

SETTINGS: The study was conducted in 3 national referral centers.

PATIENTS: From January 2006 to December 2012, 144 patients with fecal incontinence enrolled in a prospectively maintained database completed a 2- to 3-week bowel diary, at baseline and during test phase.

MAIN OUTCOME MEASURES: The primary outcome was the clinical decision to implant a pulse generator. The primary predictor was a calculated score including the number of leak episodes, bowel movements, and urgencies and the time to defer defecation expressed in minutes during the first screening test week.

RESULTS: After the first, second and third week of the test phase, 81 (56%) of 144, 96 (67%) of 144, and 93 (70%) of 131 patients had a positive test. A permanent pulse generator was implanted in 114. Time to defer defecation increased during the 3 weeks of screening. Urgencies were unchanged. The computed score was predictive of a permanent pulse generator implantation (Se = 72.6% (95% CI, 59.8–83.1); Sp = 100% (95% CI, 78.2–100); c-index = 0.86 (95% CI, 0.78–0.94)).

LIMITATIONS: No cost analysis or projection based on our proposal to reduce the test phase has been made.

CONCLUSIONS: Permanent pulse generator implantation can be safely proposed early (1-week screening) to fast responders. Nonetheless, permanent implantation may be decided as well in patients exhibiting a delayed response. Whether a rapid response to sacral nerve stimulation could be predictive of a long-term response remains to be determined. See Video Abstract at http://links.lww.com/DCR/A452.

1 Department of ColoProctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France

2 Colorectal Unit, Institut des Maladies de l’Appareil Digestif, University Hospital of Nantes, Nantes, France

3 Colorectal Unit, Department of Surgery, Grenoble Alps University Hospital, Grenoble, France

Funding/Support: None reported.

Financial Disclosure: Drs Lehur and Faucheron have a consulting agreement with Medtronic SA.

Paul-Antoine Lehur and Isabelle Etienney contributed equally to this article.

Presented at the meeting of The European Society of ColoProctology, Dublin, Ireland, September 24, 2015, and Journées Francophones d’Hépato-Gastroentérologie et d’Oncologie Digestive, Paris, France, March 18, 2016.

Correspondence: Isabelle Etienney, M.D., Department of ColoProctology, Groupe Hospitalier Diaconesses Croix Saint-Simon, 125 rue d’Avron, 75020 Paris, France. E-mail: ietienney@hopital-dcss.org

© 2017 The American Society of Colon and Rectal Surgeons