From the Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL.
Department of Obstetrics and Gynecology, University of California, Irvine, CA.
Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):659-666. doi: 10.1097/SPV.0000000000001037.
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.
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.
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.
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.
本研究旨在比较产后 3 个月发生产科肛门括约肌损伤的女性中，接受即时阴道电刺激治疗与假治疗的患者的肛门失禁症状。
在这项双盲随机对照试验中，患有产科肛门括约肌损伤的女性被随机分配接受商用阴道电刺激治疗或采用相同设备的假治疗。使用粪便失禁严重程度指数在产后 1 周（基线）和 13 周时评估肛门失禁症状的严重程度。主要结局是产后 13 周时通过总粪便失禁严重程度指数评分测量的肛门失禁症状严重程度。
2016 年 2 月至 2018 年 9 月期间，48 名女性完成了 13 周的随访。产后 13 周时，阴道电刺激组（12 分；四分位距，0-23）的粪便失禁严重程度指数中位数高于假治疗组（4 分；四分位距，0-10）（P=0.04）。与阴道电刺激组不同，假治疗组的粪便失禁严重程度指数评分改善（阴道电刺激：12 [四分位距，8-22]至 12 [四分位距，0-23] [P=0.12] 与假治疗：12 [四分位距，6-18]至 4.0 [四分位距，0-11] [P＜0.001]）符合粪便失禁严重程度指数最小重要差值的临床意义阈值。
产后 13 周时，接受产后阴道电刺激治疗的女性报告的肛门失禁症状比接受假治疗的女性更多。产科肛门括约肌损伤后进行阴道电刺激对减少肛门失禁症状无益，反而可能阻碍恢复。
