Department of Physical Medicine and Rehabilitation, Østfold Hospital Trust, Grålum, Norway.
Department of Health and Functioning, Western Norway University of Applied Sciences, Bergen, Norway.
Trials. 2021 Dec 11;22(1):900. doi: 10.1186/s13063-021-05816-2.
Little is known regarding treatment of urinary incontinence (UI) in women with chronic obstructive pulmonary disease (COPD). The aim of the study was to explore the efficacy of pelvic floor muscle training (PFMT) or cough-suppression techniques (CST) on UI in women with COPD.
A three-armed, two-centred, single-blinded, randomised controlled study was performed. Subjects were randomised to (a) PFMT for 16 weeks, (b) 2-3 educational sessions in CST, or (c) written information only. All participants completed questionnaires about UI, cough symptoms, and health status and underwent clinical examinations to evaluate the strength of the pelvic floor muscles and exercise capacity. Daily physical activity levels were measured using an activity monitor and lung function with spirometry. With a significance level of 5% and an 80% chance of detecting a significant difference between groups of 2.5 points on the ICIQ UI SF score, our sample size calculation showed that a total of 78 women, 26 in each group, was required to complete the study.
During the period 2016 to 2018, 95 women were invited to the study. A total of 42 were recruited, three were excluded and 10 (24%) dropped out during the follow-up period. Mean ICIQ-UI SF total baseline score was 9.6 (range: 1-17) and 7.0 (range: 0-16) at follow-up. Changes in subjective UI as measured with the ICIQ-UI SF questionnaire were seen in the PFMT group and control group, but not in the CST group.
Due to the low number of available participants and recruitment difficulties including practical issues such as travel distance, lack of interest, poor state of health, and high number of comorbidities, our results are inconclusive. However, reduced subjective UI was observed in the PFMT and control groups with a trend towards best effect in the PFMT group. Screening for UI is advisable in all women with COPD to be able to identify and treat these women to reduce symptom burden and improve quality of life. Future studies should focus on barriers to recruitment as well as randomised controlled studies with larger sample sizes.
ClinicalTrials.gov NCT02614105. 25th November 2015.
对于患有慢性阻塞性肺疾病（COPD）的女性患者的尿失禁（UI）治疗方法，目前所知甚少。本研究旨在探讨盆底肌训练（PFMT）或咳嗽抑制技术（CST）对 COPD 女性患者 UI 的疗效。
这是一项三臂、双中心、单盲、随机对照研究。受试者被随机分为（a）PFMT 治疗 16 周，（b）接受 2-3 次 CST 教育课程，或（c）仅接受书面信息。所有参与者都完成了关于 UI、咳嗽症状和健康状况的问卷，并接受了临床检查，以评估盆底肌肉力量和运动能力。使用活动监测器和肺活量计测量日常体力活动水平。在 5%的显著性水平和 80%的机会检测到组间 2.5 分的 ICIQ UI SF 评分的显著差异的情况下，我们的样本量计算表明，总共需要 78 名女性（每组 26 名）完成研究。
在 2016 年至 2018 年期间，共有 95 名女性受邀参加研究。共有 42 名女性入选，3 名女性被排除，10 名（24%）女性在随访期间退出。ICIQ-UI SF 总基线评分的平均得分为 9.6（范围：1-17），随访时为 7.0（范围：0-16）。PFMT 组和对照组的 ICIQ-UI SF 问卷测量的主观 UI 变化，但 CST 组没有变化。
由于参与者数量少，招募困难，包括旅行距离、缺乏兴趣、健康状况不佳以及合并症数量多等实际问题，我们的结果不确定。然而，PFMT 组和对照组的主观 UI 均有所减少，PFMT 组的效果趋势最佳。建议对所有 COPD 女性进行 UI 筛查，以便识别和治疗这些女性，减轻症状负担，提高生活质量。未来的研究应重点关注招募的障碍，以及更大样本量的随机对照研究。
ClinicalTrials.gov NCT02614105. 2015 年 11 月 25 日。
