Randomized clinical trial of sacral nerve stimulation for refractory constipation

• DOI: 10.1002/bjs.10326
• Publication Date: 2016-10-25T10:46:43Z
• Authors: 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; F Zerbib; M Simon; Q Denost; P Lepicard; P-A Lehur; G Meurette; V Wyart; C Kubis; F Mion; S Roman; H Damon; X Barth; A-M Leroi; V Bridoux; G Gourcerol; B Coffin; B Castel; C Gorbatchef; Anne Le Sidaner; M Mathonnet; V Vitton; N Lesavre; P Orsoni; L Siproudhis; C Brochard; V Desfourneaux
• Keywords: Refractory (planetary science); Sacral nerve stimulation; Lumbosacral plexus

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