title: Randomized clinical trial of sacral nerve stimulation for refractory constipation.
abstract: BACKGROUND
  Open 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.
  
  
  METHODS
  Patients 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.
  
  
  RESULTS
  Thirty-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.
  
  
  CONCLUSIONS
  These 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).
authors: 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.
authors: F
authors: F
authors: Zerbib
authors: Department of Gastroenterology, Rennes University Hospital, and Université de Rennes, Rennes, France.
authors: L
authors: L
authors: Siproudhis
authors: Institut des Maladies de l'Appareil Digestif, Nantes University Hospital, Nantes, France.
authors: P-A
authors: PA
authors: Lehur
authors: Clinical Epidemiology Unit, and Bordeaux University Hospital and INSERM CIC 1401-EC, Bordeaux, France.
authors: C
authors: C
authors: Germain
authors: Department of Digestive Physiology, Lyon University Hospital, and Université Claude Bernard, Lyon, France.
authors: F
authors: F
authors: Mion
authors: Department of Digestive and Urinary Physiology, Rouen University Hospital, and Université de Rouen, Rouen, France.
authors: A-M
authors: AM
authors: Leroi
authors: Department of Gastroenterology, Louis Mourier University Hospital, Assistance Publique - Hôpitaux de Paris, Colombes, and Université Denis Diderot Paris 7, Paris, France.
authors: B
authors: B
authors: Coffin
authors: Department of Gastroenterology, Limoges University Hospital, Limoges, France.
authors: A
authors: A
authors: Le Sidaner
authors: Department of Gastroenterology, Hôpital Nord, Assistance Publique - Hôpitaux de Marseille, and Plateforme d'Interface Clinique, CRN2M, Unité Mixte de Recherche 7286, and Aix Marseille Université, Marseille, France.
authors: V
authors: V
authors: Vitton
authors: 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.
authors: C
authors: C
authors: Bouyssou-Cellier
authors: Clinical Epidemiology Unit, and Bordeaux University Hospital and INSERM CIC 1401-EC, Bordeaux, France.
authors: G
authors: G
authors: Chene
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003248:Constipation / Q000628:therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058542:Implantable Neurostimulators; D008160:Lumbosacral Plexus; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult