Protocol of a Single-Blind Two-Arm (Waitlist Control) Parallel-Group Randomised Controlled Pilot Feasibility Study for mHealth App among Incontinent Pregnant Women

Abstract

Background: The delivery of pelvic floor muscle training (PFMT) through mHealth apps has been shown to produce promising results in improving pelvic floor muscle strength and urinary incontinence (UI). However, there is limited evidence on mHealth apps designed for pregnant women who are at high risk of developing UI. This pilot study aims to evaluate the feasibility of conducting an effectiveness trial for a newly developed PFMT app among pregnant women in Malaysia. Methods: This is a prospective, single-centre, single-blind, randomised controlled pilot feasibility study: The Kegel Exercise Pregnancy Training app (KEPT-app) Trial. Sixty-four incontinent pregnant women who attended one primary care clinic for the antenatal follow-up will be recruited and randomly assigned to either intervention or waitlist control group. The intervention group will receive the intervention, the KEPT-app developed from the Capability, Opportunity, Motivation-Behaviour (COM-B) theory with Persuasive Technology and Technology Acceptance Model. Discussion: This study will provide a fine-tuning for our future randomised control study on the recruitment feasibility methods, acceptability, feasibility, and usability of the KEPT-app, and the methods to reduce the retention rates among pregnant women with UI. Trial registration: This study was registered on ClinicalTrials.gov on 19 February 2021 (NCT04762433) and is not yet recruiting.

Effect of the App-Based Video Guidance on Prenatal Pelvic Floor Muscle Training Combined with Global Postural Re-education for Stress Urinary Incontinence Prevention: A Protocol for a Multicenter, Randomized Controlled Trial

“…This protocol is designed according to referring guidelines, consensus and high-quality studies. As a multicenter RCT, it will involve ten hospitals including tertiary hospitals and maternity hospitals located in several provinces, purposed to achieve more convincing results than other single center protocols [ 31 , 32 ].…”

Preliminary Effectiveness of mHealth App-Based Pelvic Floor Muscle Training among Pregnant Women to Improve Their Exercise Adherence: A Pilot Randomised Control Trial

“…The study was prospectively registered with ClinicalTrials.gov on 19 February 2021 (NCT04762433). The study protocol was designed and reported according to the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised pilot and feasibility trials [ 20 , 21 ] and has been published recently [ 22 ].…”

“…An online consent form was provided to eligible participants for their digital signature prior to the study commencement. The study protocol is designed and has been published elsewhere [ 22 ].…”

Feasibility and Usability of Kegel Exercise Pregnancy Training App (KEPT App) among Pregnant Women with Urinary Incontinence

“…Subgroup assessments were analysed at baseline and two months after using the app. This study protocol was published recently [ 27 ] and prospectively registered with (NCT04762433).…”

“…Additionally, the severity of UI and quality of life were also analysed. This paper reports the subgroup analysis of the pilot feasibility randomised controlled trial (RCT) study [ 27 ]. This feasibility and usability study will contribute preliminary evidence of the usability properties of a KEPT app designed with some of the persuasive features that were crucial to ensure engagement from the users [ 28 ].…”