RESUMO
BACKGROUND: The awareness and practice of pelvic floor muscle exercise (PFME) in the prevention and reduction of the rate of urinary incontinence among pregnant women was considerably poor, despite the increased prevalence of urinary incontinence during pregnancy across Malaysia. There healthcare providers do not give adequate attention to the potential impact of PFME on urinary incontinence and there is limited local intervention addressed urinary incontinence during pregnancy. The objective of this study was to determine the effectiveness of a newly developed PFME intervention in terms of knowledge, attitude, practice, self-efficacy, and urinary symptoms. METHODS: A single-blinded, two-armed, randomized control trial was included pregnant women from 18 to 20 weeks of gestation and was conducted at the Maternity Hospital of Kuala Lumpur. The intervention group received PFME in addition to the usual perinatal care. The data were collected using validated questionnaires at 4 time points: baseline, post-intervention in the early third trimester, late third trimester, and early postnatal period. The intervention effects were analyzed using a generalized estimating equation. RESULTS: The primary analysis included pregnant women who had at least one follow-up; 122 women (71.8%) in the intervention group had significant improvement in knowledge, attitude, practice, and self-efficacy, as well as in the severity of urinary incontinence over time. However, improvement was not observed in self-reported urinary incontinence. CONCLUSION: PFME can be considered an effective initial intervention to provide information about urinary incontinence prevention to pregnant women.
RESUMO
INTRODUCTION: Pelvic floor muscle training (PFMT) strongly recommended to incontinent pregnant women. The Kegel Exercise Pregnancy Training-app trial is a multicentre cluster-randomised study aims to assess the effectiveness and its cost-effectiveness of the mobile app guidance in PFMT among incontinent pregnant women. METHODS AND ANALYSIS: 370 pregnant women (aged 18 years old and above) will be recruited with International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form. Ten clusters (primary care clinics) will be randomly assigned to either PFMT or usual care in a 1:1 ratio by an independent researcher (sealed envelope). The primary outcome will be urinary incontinence, and the secondary outcomes (quality of life; PFMT adherence, psychological status and mobile apps' usability) will be assessed at four measurement time points (t0: baseline) and postintervention (t1: 4 weeks, t2: 8 weeks and t3: 8 weeks postnatal). T-test analysis will determine any significant differences at the baseline between the control and intervention groups. The mixed-model analysis will determine the effectiveness of the intervention at the population-average level for both the primary and secondary outcomes. For the cost-effectiveness analysis, expenditures during the study and 6 months after the intervention will be compared between the groups using the multiway sensitivity analysis. The recruitment planned will be in December 2020, and the planned end of the study will be in August 2021. ETHICS AND DISSEMINATION: This study protocol was approved by the Ethics Committee for Research Involving Human Subjects, Universiti Putra Malaysia (JKEUPM-2019-368) and Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, NMRR-19-412-47116 (IIR) with the ANZCTR registration. This study will obtain informed written consent from all the study participants. The results which conform with the Consolidated Standards of Reporting Trials and the Recommendations for Interventional Trials will be published for dissemination in peer-reviewed journals and conference proceedings. TRIAL REGISTRATION NUMBER: ACTRN12619000379112.