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.
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.
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.
The study was conducted in 3 national referral centers.
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.
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.
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)).
No cost analysis or projection based on our proposal to reduce the test phase has been made.
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: email@example.com