Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, National Clinical Research Center for Obstetric and Gynecologic Diseases, Beijing, China.
Department of Obstetrics and Gynecology, Tongren Hospital, Shanghai Jiao Tong University, Shanghai, China.
JAMA Netw Open. 2024 Nov 4;7(11):e2442925. doi: 10.1001/jamanetworkopen.2024.42925.
Supervised pelvic floor muscle training (PFMT) has been recommended as the first-line treatment for women with stress urinary incontinence (SUI), but more evidence on whether adjunctive methods would provide additional benefits is needed.
To compare the efficacy of PFMT with or without a home-based pressure-mediated biofeedback (BF) device.
DESIGN, SETTING, AND PARTICIPANTS: This multicenter assessor-blinded randomized clinical trial was conducted in the obstetric clinics of 5 participating tertiary hospitals in China. Participants included eligible women with new-onset postpartum SUI who were enrolled from March 28, 2022, to October 13, 2023.
All participants received 3 months of supervised PFMT and were randomized to either the intervention (PFMT with a home-based pressure-mediated BF device) or the control group (home-based PFMT).
The primary outcome was the severity of urinary incontinence evaluated by the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form after 3 months of supervised PFMT. The secondary outcomes included the cure and improvement rates, PFM strength, quality of life, self-efficacy, and adherence.
A total of 452 participants (median age, 34 [IQR, 31-36] years; median body mass index [calculated as the weight in kilograms divided by the height in square meters], 23.71 [IQR, 21.37-25.97]; median time since delivery, 50 [IQR, 43-61] days) were included in the analysis, with 223 in the intervention group and 229 in the control group. Compared with the control group, the intervention group achieved a significantly greater reduction in incontinence severity (median, 3.00 [IQR, 1.00-6.00] vs 2.00 [IQR, 0-4.00] points; z = -3.05; P = .002), significantly increased cure rate (45 of 223 [20.2%] vs 20 of 229 [8.7%]; z = 12.02; P = .001) and improvement (132 of 223 [59.2%] vs 102 of 229 [44.5%]; z = 9.71; P = .002), significantly greater pelvic floor muscle strength (median, 26.00 [IQR, 17.00-38.00] vs 21.00 [IQR, 13.50-33.50] cm H2O; z = -2.28; P = .02), and a significantly greater correlation between subjective and objective adherence (r = 0.825 vs r = 0.627).
In this randomized clinical trial, the efficacy of pressure-mediated BF combined with PFMT was superior to that of PFMT alone. These findings support the use of pressure-mediated BF devices for improving treatment outcomes for patients with SUI.
ClinicalTrials.gov Identifier: NCT05115864.
重要性：有研究推荐监督下的盆底肌训练（PFMT）作为压力性尿失禁（SUI）女性的一线治疗方法，但仍需要更多关于辅助方法是否会提供额外益处的证据。
目的：比较 PFMT 联合或不联合家庭压力介导生物反馈（BF）设备的疗效。
设计、地点和参与者：这是一项多中心评估者盲法随机临床试验，在中国 5 家参与的三级医院的产科诊所进行。参与者包括新出现产后 SUI 的合格女性，于 2022 年 3 月 28 日至 2023 年 10 月 13 日入组。
干预措施：所有参与者均接受 3 个月的监督性 PFMT，并随机分为干预组（PFMT 联合家庭压力介导 BF 设备）或对照组（家庭 PFMT）。
主要结局和测量：主要结局是 3 个月监督性 PFMT 后，通过国际尿失禁咨询问卷-尿失禁简短问卷评估的尿失禁严重程度。次要结局包括治愈率和改善率、PFM 力量、生活质量、自我效能和依从性。
结果：共有 452 名参与者（中位数年龄，34 [IQR，31-36] 岁；中位数体重指数[体重以千克为单位除以身高以米为单位计算]，23.71 [IQR，21.37-25.97]；中位数分娩后时间，50 [IQR，43-61] 天）纳入分析，其中干预组 223 名，对照组 229 名。与对照组相比，干预组尿失禁严重程度显著降低（中位数，3.00 [IQR，1.00-6.00] 比 2.00 [IQR，0-4.00] 点；z=-3.05；P=0.002），治愈率显著提高（45/223 [20.2%] 比 20/229 [8.7%]；z=12.02；P=0.001）和改善率（132/223 [59.2%] 比 102/229 [44.5%]；z=9.71；P=0.002），PFM 力量显著增强（中位数，26.00 [IQR，17.00-38.00] 比 21.00 [IQR，13.50-33.50] cm H2O；z=-2.28；P=0.02），主观和客观依从性之间的相关性显著增强（r=0.825 比 r=0.627）。
结论和相关性：在这项随机临床试验中，压力介导 BF 联合 PFMT 的疗效优于单独 PFMT。这些发现支持使用压力介导 BF 设备来改善 SUI 患者的治疗效果。
试验注册：ClinicalTrials.gov 标识符：NCT05115864。
