Faculty of Health, Medicine and Life Sciences, Department Epidemiology, CAPHRI Care and Public Health Research Institute, Maastricht University, P.O. Box 616, 6200, MD, Maastricht, The Netherlands.
Maastricht University Medical Centre, P.O. Box 5800, 6202, AZ, Maastricht, The Netherlands.
Trials. 2019 Apr 25;20(1):237. doi: 10.1186/s13063-019-3331-6.
Stress urinary incontinence (SUI) is highly prevalent during pregnancy and after delivery. It is often associated with a failing pelvic floor, sphincteric and/or supportive system. Pelvic-floor-muscle training (PFMT) peri-partum has been proven effective for up to 1 year post-partum; however, its long-term effects are unknown. Group PFMT, given by a physiotherapist, has been proven to be as equally effective as individual therapy. Motherfit is a group-PFMT therapy with an emphasis on pelvic floor exercises, adherence and general fitness. Care-as-usual (CAU), if guideline driven, should, as first treatment option, consist of PFMT. Cost-effective strategies are of relevance, given the rise of health care costs. Motherfit group therapy has the potential to be cost-effective in women with urinary incontinence. Therefore, the objectives of the two current studies are: (1) to investigate whether intensive, supervised, pre-partum (MOTHERFIT1) or post-partum (MOTHERFIT2) pelvic-floor-muscle group therapy reduces 18-month post-partum severity of SUI compared to CAU and (2) whether MOTHERFIT1 OR MOTHERFIT 2 is more (cost-)effective compared to CAU.
Two multi-centred, randomised controlled trials (MOTHERFIT1, n = 150, MOTHERFIT2, n = 90) will be performed. Participants will be recruited by their midwife or gynaecologist during their routine check. Participants with SUI will receive either motherfit group therapy or CAU. Motherfit group therapy consists of eight group sessions of 60 min each, instructed and supervised by a registered pelvic physiotherapist. Motherfit group therapy includes instructions on pelvic floor anatomy and how to contract, relax and train the pelvic-floor muscles correctly and is combined with general physical exercises. Adherence during and after motherfit will be stimulated by reinforcement techniques and a mobile app. The primary outcome measure is the absence of self-reported SUI based on the severity sum score of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI-SF) at 18 months post-partum. Secondary outcomes evaluate quality of life, subjective improvement and health care costs.
The motherfit studies are, to our knowledge, the first studies that evaluate both long-term results and health care costs compared to CAU in pregnant and post-partum women with SUI. If motherfit is shown to be (cost-)effective, implementation in peri-partum care should be considered.
Netherlands Trial Register, ID: NL5816 . Registered on 18 July 2016.
压力性尿失禁（SUI）在妊娠和分娩后非常普遍。它通常与盆底功能障碍、括约肌和/或支持系统有关。围产期盆底肌训练（PFMT）已被证明在产后 1 年内有效；然而，其长期效果尚不清楚。由物理治疗师进行的小组 PFMT 已被证明与个体治疗同样有效。Motherfit 是一种强调盆底运动、坚持和一般健康的小组-PFMT 治疗方法。如果遵循指南，常规护理（CAU）应将 PFMT 作为首选治疗方案。鉴于医疗保健成本的上升，具有成本效益的策略具有重要意义。Motherfit 小组治疗有可能对尿失禁女性具有成本效益。因此，目前两项研究的目的是：（1）比较产前（MOTHERFIT1）或产后（MOTHERFIT2）密集、监督的盆底肌肉小组治疗与 CAU 相比，是否能降低产后 18 个月时 SUI 的严重程度；（2）比较 Motherfit1 或 Motherfit2 是否比 CAU 更具（成本）效益。
将进行两项多中心、随机对照试验（MOTHERFIT1，n=150，MOTHERFIT2，n=90）。参与者将由他们的助产士或妇科医生在常规检查期间招募。患有 SUI 的参与者将接受 Motherfit 小组治疗或 CAU。Motherfit 小组治疗包括八节 60 分钟的小组课程，由注册的盆底物理治疗师指导和监督。Motherfit 小组治疗包括盆底解剖学的说明以及如何正确收缩、放松和训练盆底肌肉，并结合一般体育锻炼。通过强化技术和移动应用程序来促进 Motherfit 期间和之后的依从性。主要结局测量指标是产后 18 个月时根据国际尿失禁咨询问卷短表（ICIQ-UI-SF）严重程度总和评分评估的自我报告 SUI 缺失。次要结局评估生活质量、主观改善和医疗保健成本。
据我们所知，Motherfit 研究是首次在患有 SUI 的孕妇和产后妇女中评估与 CAU 相比的长期结果和医疗保健成本的研究。如果 Motherfit 被证明具有（成本）效益，应考虑在围产期护理中实施。
荷兰试验注册处，ID：NL5816。于 2016 年 7 月 18 日注册。
