Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery: A Randomized Clinical Trial.

OBJECTIVE: The aim of this study was to compare 3-month postpartum anal incontinence symptoms in women who sustain obstetric anal sphincter injuries and begin immediate vaginal electrical stimulation versus sham therapy. METHODS: In this double-blind randomized controlled trial, women who sustained obstetric anal sphincter injuries were randomized to receive self-administered vaginal electrical stimulation using a commercial device or sham therapy with an identical device. Anal incontinence symptom severity was assessed at 1 week (baseline) and again at 13 weeks postpartum using the Fecal Incontinence Severity Index. The primary outcome was anal incontinence symptom severity measured by the total Fecal Incontinence Severity Index score at 13 weeks postpartum. RESULTS: Between February 2016 and September 2018, 48 women completed a 13-week follow-up. At 13 weeks postpartum, median Fecal Incontinence Severity Index scores were higher (more severe) in the vaginal electrical stimulation group (12; interquartile range, 0-23) than in the sham group (4; interquartile range, 0-10) (P = 0.04). Unlike the vaginal electrical stimulation group, the improvement in Fecal Incontinence Severity Index scores in the sham group (vaginal electrical stimulation: 12 [interquartile range, 8-22] to 12 [interquartile range, 0-23] [P = 0.12] vs sham: 12 [interquartile range, 6-18] to 4.0 [interquartile range, 0-11] [P < 0.001]) met the threshold for clinical significance based on the minimum important difference of the Fecal Incontinence Severity Index. CONCLUSION: At 13 weeks postpartum, women who underwent postpartum vaginal electrical stimulation reported more anal incontinence symptoms compared with those receiving sham therapy. Vaginal electrical stimulation after obstetric anal sphincter injury was not beneficial in reducing anal incontinence symptoms and may impede recovery.