Chen Chunmei, Zhang Jing, Zhang Hong, Li Haiyan, Yu Jucheng, Pei Yao, Fang Yuan
Department of Women's Health, School of Medicine, Chengdu Women's and Children's Central Hospital, The Affiliatedffiliatedffiliated Women's and Children's Hospital, University of Electronic Science and Technology of China, Chengdu, China.
Department of Women's Health, Jinniu Maternity and Child Health Hospital of Chengdu, Chengdu, China.
Trials. 2024 Apr 26;25(1):285. doi: 10.1186/s13063-024-08103-y.
Urinary incontinence is highly prevalent in women while pelvic floor muscle training is recommended as the first-line therapy. However, the exact treatment regimen is poorly understood. Also, patients with pelvic floor muscle damage may have decreased muscle proprioception and cannot contract their muscles properly. Other conservative treatments including electromagnetic stimulation are suggested by several guidelines. Thus, the present study aims to compare the effectiveness of electromagnetic stimulation combined with pelvic floor muscle training as a conjunct treatment for urinary incontinence and different treatment frequencies will be investigated.
METHODS/DESIGN: This is a randomized, controlled clinical trial. We will include 165 patients with urinary incontinence from the outpatient center. Participants who meet the inclusion criteria will be randomly allocated to three groups: the pelvic floor muscle training group (active control group), the low-frequency electromagnetic stimulation group (group 1), and the high-frequency electromagnetic stimulation group (group 2). Both group 1 and group 2 will receive ten sessions of electromagnetic stimulation. Group 1 will be treated twice per week for 5 weeks while group 2 will receive 10 days of continuous treatment. The primary outcome is the change in International Consultation on Incontinence Questionnaire-Short Form cores after the ten sessions of the treatment, while the secondary outcomes include a 3-day bladder diary, pelvic floor muscle function, pelvic organ prolapse quantification, and quality of life assessed by SF-12. All the measurements will be assessed at baseline, after the intervention, and after 3 months of follow-up.
The present trial is designed to investigate the effects of a conjunct physiotherapy program for urinary incontinence in women. We hypothesize that this strategy is more effective than pelvic floor muscle training alone, and high-frequency electromagnetic stimulation will be superior to the low-frequency magnetic stimulation group.
尿失禁在女性中极为普遍，盆底肌肉训练被推荐作为一线治疗方法。然而，确切的治疗方案尚不清楚。此外，盆底肌肉受损的患者可能肌肉本体感觉下降，无法正确收缩肌肉。多项指南建议采用包括电磁刺激在内的其他保守治疗方法。因此，本研究旨在比较电磁刺激联合盆底肌肉训练作为尿失禁联合治疗方法的有效性，并研究不同的治疗频率。
方法/设计：这是一项随机对照临床试验。我们将纳入门诊中心的165例尿失禁患者。符合纳入标准的参与者将被随机分为三组：盆底肌肉训练组（活性对照组）、低频电磁刺激组（第1组）和高频电磁刺激组（第2组）。第1组和第2组都将接受10次电磁刺激。第1组每周治疗2次，共5周，而第2组将接受连续10天的治疗。主要结局是治疗10次后尿失禁咨询国际问卷简表核心内容的变化，次要结局包括3天膀胱日记、盆底肌肉功能、盆腔器官脱垂量化以及通过SF-12评估的生活质量。所有测量将在基线、干预后和随访3个月后进行评估。
本试验旨在研究一种联合物理治疗方案对女性尿失禁的影响。我们假设这种策略比单独的盆底肌肉训练更有效，并且高频电磁刺激将优于低频磁刺激组。
