• F Zerbib, L Siproudhis, P-A Lehur, C Germain, F Mion, A-M Leroi, B Coffin, A Le Sidaner, V Vitton, C Bouyssou-Cellier, G Chene, and CONSTIMOD study investigators.
• Department of Gastroenterology, Bordeaux University Hospital, and Université de Bordeaux and Institut National de la Santé et de la Recherche Médicale (INSERM) CIC 1401, Bordeaux, France.
• Br J Surg. 2017 Feb 1; 104 (3): 205-213.

BackgroundOpen studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT.MethodsPatients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year.ResultsThirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time.ConclusionThese results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).© 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

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