App-Based Treatment in Primary Care for Urinary Incontinence

A Pragmatic, Randomized Controlled Trial

Anne M. M. Loohuis, MD; Nienke J. Wessels, MD, PhD; Janny H. Dekker, MD, PhD; Nadine A. M. van Merode, MD; Marijke C. Ph. Slieker-ten Hove, PhD; Boudewijn J. Kollen, PhD; Marjolein Y. Berger, MD, PhD; Henk van der Worp, PhD; Marco H. Blanker, MD, PhD

Disclosures

Ann Fam Med. 2021;19(2):102-109. 

In This Article

Abstract and Introduction

Abstract

Purpose: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting.

Methods: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis.

Results: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (−2.16 points; 95% CI, −2.67 to −1.65) was noninferior to that with usual care (−2.56 points; 95% CI, −3.28 to −1.84), with a mean difference of 0.058 points (95% CI, −0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment.

Conclusions: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

Introduction

Conservative treatment for female urinary incontinence (UI) can be time-consuming, and adherence varies, which limit its effectiveness.[1] Electronic application (app)-based treatment that delivers advice, training, and motivation for managing UI by oneself could offer advantages over usual care, removing the barriers to treatment access and improving adherence to training. We cannot justify prescribing an app for UI, however, unless it has been shown to be at least noninferior to current best practice.

More than 100 apps for UI management are already available, yet evidence for their effectiveness is scarce. Moreover, these apps tend to focus on stress UI alone and to have diverse contents.[2] In a Swedish study, app treatment improved UI symptoms and quality of life after 3 months compared with postponed treatment and was cost-effective at 12 months.[3] A recent small Brazilian study also showed increased adherence to pelvic floor muscle exercises and an improvement in UI symptoms after 3 months of app-based treatment compared with written instructions alone.[4] To date, there have been no studies comparing app-based treatment with usual care or treatment for urgency or mixed UI. This gap in the evidence is important because the majority of women with UI have stress, urgency, or mixed-type UI.[5]

We developed an app for use by women with stress, urgency, and mixed UI, requiring no caregiver support. In this study, we specifically assessed whether app-based treatment with this tool was noninferior to usual care provided by general practitioners after 4 months.

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