1. Randomized clinical trial of sacral nerve stimulation for refractory constipation
- Author
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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, M Simon, Q Denost, P Lepicard, G Meurette, V Wyart, C Kubis, S Roman, H Damon, X Barth, V Bridoux, G Gourcerol, B Castel, C Gorbatchef, Anne Le Sidaner, M Mathonnet, N Lesavre, P Orsoni, C Brochard, V Desfourneaux, CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Foie, métabolismes et cancer, Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Rouen, Normandie Université (NU), Université Paris Diderot - Paris 7 (UPD7), CHU Limoges, Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), This study was funded by a grant from the French Ministry of Health (PHRC 2011) and promoted by Bordeaux University Hospital (Délégation à la Recherche Clinique, Centre Hospitalier Universitaire de Bordeaux)., CHU Bordeaux [Bordeaux], CHU Rennes - Service gastroentérologie, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL), Service de physiologie digestive, urinaire, respiratoire et de l'exercice [CHU Rouen], Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Hôpital Charles Nicolle [Rouen], Nutrition, inflammation et dysfonctionnement de l'axe intestin-cerveau (ADEN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institute for Research and Innovation in Biomedicine (IRIB), UNIROUEN - UFR Santé (UNIROUEN UFR Santé), Normandie Université (NU)-Normandie Université (NU), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP), CHU Marseille, Enjalbert, Alain, and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique )
- Subjects
Adult ,Male ,medicine.medical_specialty ,Constipation ,Adolescent ,[SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology ,Lumbosacral Plexus ,Electric Stimulation Therapy ,Stimulation ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Hematoma ,Double-Blind Method ,Randomized controlled trial ,Refractory ,law ,medicine ,Humans ,ComputingMilieux_MISCELLANEOUS ,Aged ,Cross-Over Studies ,business.industry ,[SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology ,[SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Middle Aged ,medicine.disease ,Crossover study ,[SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology ,Surgery ,Lumbosacral plexus ,Implantable Neurostimulators ,Treatment Outcome ,030220 oncology & carcinogenesis ,Anesthesia ,Defecation ,Female ,030211 gastroenterology & hepatology ,medicine.symptom ,business ,Follow-Up Studies - 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. Conclusion 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).
- Published
- 2016
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