Treatment Efficacy of Sacral Nerve Stimulation in Slow Transit Constipation: A Two-Phase, Double-Blind Randomized Controlled Crossover Study

• DOI: 10.1038/ajg.2015.101
• Publication Date: 2015-04-21T12:21:23Z
• Authors: Phil G Dinning; Linda Hunt; Vicki Patton; Teng Zhang; Michal Szczesniak; Val Gebski; Mike Jones; Peter Stewart; David Z Lubowski; Ian J Cook
• Keywords: Crossover study; Refractory (planetary science)

Objectives: Sacral nerve stimulation (SNS) is a potential treatment for constipation refractory to standard therapies. However, there have been no randomized controlled studies examining its efficacy. In patients with slow transit constipation, we evaluated the efficacy of suprasensory and subsensory SNS compared sham, in prospective, 18-week randomized, double-blind, placebo-controlled, two-phase crossover study. The primary outcome measure was proportion who, on more than 2 days/week at least 3 weeks, reported bowel movement associated feeling complete evacuation. Methods: After weeks temporary peripheral evaluation (PNE), all had permanent implantation were subsensory/sham (3 each) then re-randomized suprasensory/sham 2-week washout period between each arm. Daily stool dairies kept, quality life (QoL; SF36) measured end Results: Between November 2006 March 2012, 234 constipated assessed, whom 59 willing deemed eligible participate (4 male; median age 42 years). Of patients, 16 (28%) responded PNE. Fifty-five went implantation. satisfying did not differ (30%) sham (21%) stimulations, nor (25%) stimulations. There significant changes QoL scores. Conclusions: improve frequency movements over 3-week active period.