Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, and the Division of Obstetrics and Gynecology, Södersjukhuset, Stockholm, Sweden.
Obstet Gynecol. 2020 Feb;135(2):341-351. doi: 10.1097/AOG.0000000000003653.
To evaluate outcomes after pelvic floor muscle therapy, as compared with perineorrhaphy and distal posterior colporrhaphy, in the treatment of women with a poorly healed second-degree obstetric injury diagnosed at least 6 months postpartum.
We performed a single center, open-label, randomized controlled trial. After informed consent, patients with a poorly healed second-degree perineal tear at minimum 6 months postpartum were randomized to either surgery or physical therapy. The primary outcome was treatment success, as defined by Patient Global Impression of Improvement, at 6 months. Secondary outcomes included the Pelvic Floor Distress Inventory, the Pelvic Floor Impact Questionnaire, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the Hospital Anxiety and Depression Scale. Assuming a 60% treatment success in the surgery group and 20% in the physical therapy group, plus anticipating a 20% loss to follow-up, a total of 70 patients needed to be recruited.
From October 2015 to June 2018, 70 of 109 eligible patients were randomized, half into surgery and half into tutored pelvic floor muscle therapy. The median age of the study group was 35 years, and the median duration postpartum at enrollment in the study was 10 months. There were three dropouts in the surgery group postrandomization. In an intention-to-treat analysis, with worst case imputation of missing outcomes, subjective global improvement was reported by 25 of 35 patients (71%) in the surgery group compared with 4 of 35 patients (11%) in the physical therapy group (treatment effect in percentage points 60% [95% CI 42-78%], odds ratio 19 [95% CI 5-69]). The surgery group was superior to physical therapy regarding all secondary endpoints.
Surgical treatment is effective and superior to pelvic floor muscle training in relieving symptoms related to a poorly healed second-degree perineal tear in women presenting at least 6 months postpartum.
ClinicalTrials.gov, NCT02545218.
评估盆底肌治疗与会阴修补术和后阴道远端修补术相比，在治疗产后至少 6 个月诊断为愈合不良的二度产科损伤女性患者中的效果。
我们进行了一项单中心、开放标签、随机对照试验。在获得知情同意后，将产后至少 6 个月存在愈合不良的二度会阴撕裂的患者随机分为手术组或物理治疗组。主要结局为 6 个月时的治疗效果，定义为患者整体改善印象。次要结局包括盆底窘迫量表、盆底影响问卷、盆腔器官脱垂/尿失禁性疾病问卷和医院焦虑抑郁量表。假设手术组的治疗成功率为 60%，物理治疗组为 20%，加上 20%的随访丢失，共需要招募 70 名患者。
2015 年 10 月至 2018 年 6 月，109 名符合条件的患者中有 70 名被随机分组，其中一半接受手术，一半接受指导盆底肌治疗。研究组的中位年龄为 35 岁，入组时产后中位时间为 10 个月。手术组有 3 名患者在随机分组后退出。在意向治疗分析中，对缺失结果进行最差情况推断，手术组 35 名患者中有 25 名（71%）报告主观整体改善，而物理治疗组 35 名患者中有 4 名（11%）（治疗效果百分比 60%[95%CI 42-78%]，比值比 19[95%CI 5-69%]）。手术组在所有次要终点均优于物理治疗。
对于产后至少 6 个月出现愈合不良的二度会阴撕裂的女性患者，手术治疗在缓解症状方面是有效且优于盆底肌训练。
ClinicalTrials.gov，NCT02545218。
