Tian Zhao, Wang Xiuqi, Fu Linru, Du Zhe, Lin Tangdi, Chen Wei, Sun Zhijing
Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, National Clinical Research Center for Obstetric & Gynaecologic Diseases, Beijing, People's Republic of China.
Department of Clinical Nutrition, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
BMJ Open. 2025 Mar 27;15(3):e092789. doi: 10.1136/bmjopen-2024-092789.
Recent guidelines suggest behavioural weight loss (BWL) and pelvic floor muscle training (PFMT) as first-line treatment approaches for women with both obesity and stress urinary incontinence (SUI). However, the optimal therapeutic and management strategies for these populations remain uncertain.
This assessor-blinded parallel-group randomised controlled trial aims to compare the efficacy of BWL alone, BWL plus conventional PFMT and BWL plus PFMT with a biofeedback device for women who are overweight or obese experiencing SUI or SUI-predominant mixed urinary incontinence. A total of 120 eligible women will be randomly assigned at a 1:1:1 ratio. All the three groups will be subjected to a 3-month self-supervision intervention after randomisation and will be assessed at baseline, after the 3-month intervention, 6 months after the intervention and 12 months after the intervention. The primary outcome measure is the self-reported severity of urinary incontinence assessed by the International Consultation on Incontinence Questionnaire-Urinary Incontinence short form. The secondary outcomes include weight loss effectiveness, pelvic muscle strength, pelvic floor ultrasound, three-dimensional body posture, adherence to the intervention and questionnaires for symptoms of pelvic organ prolapse, quality of life and sexual function.
This study has been approved by the Peking Union Medical College Hospital ethics committee (K5504). All results from the study will be submitted to international journals and international conferences.
This trial has been registered with the Chinese Clinical Trial Registry (ChiCTR2400084015).
近期指南建议，行为减肥（BWL）和盆底肌肉训练（PFMT）作为肥胖且患有压力性尿失禁（SUI）女性的一线治疗方法。然而，这些人群的最佳治疗和管理策略仍不明确。
本评估者盲法平行组随机对照试验旨在比较单纯BWL、BWL加传统PFMT以及BWL加生物反馈设备的PFMT对超重或肥胖且患有SUI或以SUI为主的混合性尿失禁女性的疗效。总共120名符合条件的女性将按1:1:1的比例随机分配。三组在随机分组后均接受为期3个月的自我监督干预，并在基线、3个月干预后、干预后6个月和干预后12个月进行评估。主要结局指标是通过国际尿失禁咨询委员会尿失禁简表自我报告的尿失禁严重程度。次要结局包括减肥效果、盆底肌肉力量、盆底超声、三维身体姿势、干预依从性以及盆腔器官脱垂症状问卷、生活质量和性功能问卷。
本研究已获得北京协和医院伦理委员会批准（K5504）。研究的所有结果将提交给国际期刊和国际会议。
本试验已在中国临床试验注册中心注册（ChiCTR2400084015）。
