Lange Sören, Lange Rainer, Tabibi Elham, Hitschold Thomas, Müller Veronika I, Naumann Gert
Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.
Department of Gynecology, University Hospital Zurich, Zurich, Switzerland.
Geburtshilfe Frauenheilkd. 2024 Mar 6;84(3):246-255. doi: 10.1055/a-2243-3784. eCollection 2024 Mar.
To compare three conservative treatment options, standard care, pelvic floor muscle training (PFMT), and vaginal pessaries, for postpartum urinary incontinence (UI) that are accessible to most patients and practitioners in a generalizable cohort.
A multicenter, open-label, parallel group, pragmatic randomized controlled clinical trial comparing standard care, PFMT, and vaginal cube pessary for postpartum urinary incontinence was conducted in six outpatient clinics. Sample size was based on large treatment effects (Cramers' V > 0.35) with a power of 80% and an alpha of 0.05 for a 3 × 3 contingency table, 44 patients needed to be included in the trial. Outcomes were analyzed according to the intention-to-treat principle. Group comparisons were made using analysis of variance (ANOVA), Kruskal-Wallis, and chi-square test as appropriate. P < 0.05 was considered statistically significant.
Of the 516 women screened, 111 presented with postpartum UI. Of these, 52 were randomized to one of three treatment groups: standard care (n = 17), pelvic floor muscle training (n = 17), or vaginal cube pessary (n = 18). After 12 weeks of treatment, treatment success, as measured by patient satisfaction, was significantly higher in the vaginal pessary group (77.8%, n = 14/18), compared to the standard care group (41.2%, n = 7/17), and the PFMT (23.5%, n = 4/17; χ = 14.55; p = 0.006, Cramer-V = 0.374). No adverse events were reported. SUI and MUI accounted for 88.4% of postpartum UI.
Vaginal pessaries were superior to standard care or PFMT to satisfyingly reduce postpartum UI symptoms. No complications were found.
为比较三种保守治疗方案，即标准护理、盆底肌肉训练（PFMT）和阴道子宫托，用于大多数患者和从业者在可推广队列中治疗产后尿失禁（UI）的效果。
在六个门诊诊所进行了一项多中心、开放标签、平行组、实用随机对照临床试验，比较标准护理、PFMT和阴道立方子宫托治疗产后尿失禁的效果。样本量基于大的治疗效果（克莱默斯V>0.35），检验效能为80%，对于3×3列联表，α为0.05，试验需要纳入44例患者。根据意向性分析原则对结果进行分析。根据情况使用方差分析（ANOVA）、克鲁斯卡尔-沃利斯检验和卡方检验进行组间比较。P<0.05被认为具有统计学意义。
在516名筛查的女性中，111名出现产后UI。其中，52名被随机分配到三个治疗组之一：标准护理组（n = 17）、盆底肌肉训练组（n = 17）或阴道立方子宫托组（n = 18）。治疗12周后，以患者满意度衡量的治疗成功率，阴道子宫托组（77.8%，n = 14/18）显著高于标准护理组（41.2%，n = 7/17）和PFMT组（23.5%，n = 4/17；χ² = 14.55；p = 0.006，克莱默斯V = 0.374）。未报告不良事件。压力性尿失禁（SUI）和混合性尿失禁（MUI）占产后UI的88.4%。
阴道子宫托在令人满意地减轻产后UI症状方面优于标准护理或PFMT。未发现并发症。
