School of Rehabilitation Science, McMaster University, Hamilton, ON, Canada.
Department of Obstetrics & Gynecology, McMaster University, Hamilton, ON, Canada.
JMIR Mhealth Uhealth. 2019 Jul 11;7(7):e12587. doi: 10.2196/12587.
The postpartum period is a vulnerable time for the pelvic floor. Early implementation of pelvic floor muscle exercises, appropriately termed as pelvic floor muscle training (PFMT), in the postpartum period has been advocated because of its established effectiveness. The popularity of mobile health (mHealth) devices highlights their perceived utility. The effectiveness of various mHealth technologies with claims to support pelvic floor health and fitness is yet to be substantiated through systematic inquiry.
The aim of this study was to determine the acceptability, feasibility, and potential effect on outcomes of an mHealth device purposed to facilitate pelvic floor muscle training among postpartum women.
A 16-week mixed methods pilot study was conducted to evaluate outcomes and determine aspects of acceptability and feasibility of an mHealth device. All participants received standardized examination of their pelvic floor muscles and associated instruction on the correct performance of PFMT. Those randomized to the iBall intervention received instructions on its use. Schedules for utilization of the iBall and PFMT were not prescribed, but all participants were informed of the standard established recommendation of PFMT, which includes 3 sets of 10 exercises, 3 to 4 times a week, for the duration of the intervention period. Quantitative data included the measurement of pelvic floor muscle parameters (strength, endurance, and coordination) following the PERFECT assessment scheme: Incontinence Impact Questionnaire scores and the Urogenital Distress Inventory (UDI-6) scores. Aspects of acceptability and feasibility were collected through one-to-one interviews. Interview transcripts were analyzed using Thorne's interpretive description approach.
A total of 23 women with a mean age of 32.2 years were randomized to an intervention group (n=13) or a control group (n=10). Both groups improved on all measures. The only statistically significant change was the UDI-6 score within both groups at 16 weeks compared with baseline. There was no statistically significant difference between the intervention group and control group on any outcomes. Most participants using the iBall (n=10, 77%) indicated value in the concept of the mHealth solution. Technical difficulties (n=10, 77%), a cumbersome initiation process (n=8, 61%), and discomfort from the device (n=8, 61%) were reasons impeding intervention acceptability. Most participants (n=17, 74%) indicated that the initial assessment and training was more useful than the mHealth solution, a tenet that was echoed by all control group participants.
Our pilot study demonstrated the potential for mHealth solution-enhanced PFMT in the early postpartum period. Usability issues in hardware and software hindered feasibility and acceptance by the participants. Our findings can inform the redesign of mHealth solutions that may be of value if acceptability and feasibility issues can be overcome.
ClinicalTrials.gov NCT02865954; https://clinicaltrials.gov/ct2/show/NCT02865954.
产后时期是盆底的脆弱时期。由于盆底肌肉训练（pelvic floor muscle training，PFMT）已被证实有效，因此提倡在产后早期实施。移动健康（mobile health，mHealth）设备的普及突显了它们的实用性。各种声称支持盆底健康和健身的 mHealth 技术的有效性仍需通过系统研究来证实。
本研究旨在确定一种 mHealth 设备在促进产后妇女进行盆底肌肉训练方面的可接受性、可行性和潜在效果。
进行了一项为期 16 周的混合方法试点研究，以评估结果，并确定 mHealth 设备的可接受性和可行性方面。所有参与者都接受了盆底肌肉的标准化检查，并接受了正确进行 PFMT 的相关指导。随机分配到 iBall 干预组的参与者接受了使用说明。未规定 iBall 和 PFMT 的使用时间表，但告知所有参与者 PFMT 的标准建议，包括在干预期间每周 3 到 4 次，每次 3 组，每组 10 次。定量数据包括使用 PERFECT 评估方案测量的盆底肌肉参数（力量、耐力和协调性）：尿失禁影响问卷评分和尿失禁生活质量问卷评分。可接受性和可行性方面的信息通过一对一访谈收集。访谈记录采用 Thorne 的解释性描述方法进行分析。
共有 23 名平均年龄为 32.2 岁的女性被随机分配到干预组（n=13）或对照组（n=10）。两组在所有指标上均有改善。唯一具有统计学意义的变化是两组在 16 周时与基线相比，尿失禁生活质量问卷评分有改善。干预组和对照组在任何结果上均无统计学差异。大多数使用 iBall 的参与者（n=10，77%）表示对 mHealth 解决方案的概念有价值。技术问题（n=10，77%）、繁琐的启动过程（n=8，61%）和设备不适（n=8，61%）是阻碍干预可接受性的原因。大多数参与者（n=17，74%）表示初始评估和培训比 mHealth 解决方案更有用，这一观点也得到了对照组所有参与者的认同。
我们的试点研究表明，mHealth 解决方案增强的 PFMT 在产后早期具有潜力。硬件和软件的可用性问题阻碍了参与者的接受度和可行性。如果能够克服可接受性和可行性问题，我们的研究结果可能会为有价值的 mHealth 解决方案的设计提供信息。
ClinicalTrials.gov NCT02865954；https://clinicaltrials.gov/ct2/show/NCT02865954。
