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KEPT-app trial: a pragmatic, single-blind, parallel, cluster-randomised effectiveness study of pelvic floor muscle training among incontinent pregnant women: study protocol

Sidik SM 1 , Jaffar A 2 , Foo CN 3 , Muhammad NA 4 , Abdul Manaf R 5 , Ismail SIF 2 Show all authors , Alagirisamy P 6 , Ahmad Fazlah AF 7 , Suli Z 8 , Goodyear-Smith F 9

Affiliations 

  • 1 Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia sherina@upm.edu.my
  • 2 Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia
  • 3 Department of Population Medicine, Universiti Tunku Abdul Rahman, Kajang, Malaysia
  • 4 Department of Family Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia
  • 5 Department of Community Health, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia
  • 6 Rehabilitation Department, KPJ Damansara Specialist Hospital, Damansara, Malaysia
  • 7 Computer Science Department, Faculty of Defence Science and Technology, Universiti Pertahanan Nasional Malaysia, Kuala Lumpur, Malaysia
  • 8 Selangor State Health Department, Hulu Langat District Health Office, Kajang, Malaysia
  • 9 Department of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand
BMJ Open, 2021 01 12;11(1):e039076.
PMID: 33436465 DOI: 10.1136/bmjopen-2020-039076

Abstract

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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