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Randomized Controlled Trial
. 2021 Mar-Apr;19(2):102-109.
doi: 10.1370/afm.2585.

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

Anne M M Loohuis  1 , Nienke J Wessels  2 , Janny H Dekker  2 , Nadine A M van Merode  2 , Marijke C Ph Slieker-Ten Hove  3 , Boudewijn J Kollen  2 , Marjolein Y Berger  2 , Henk van der Worp  2 , Marco H Blanker  2
Affiliations
Randomized Controlled Trial

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial

Anne M M Loohuis et al. Ann Fam Med. 2021 Mar-Apr.

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.

Keywords: app; eHealth; general practice; medical informatics; noninferiority; practice-based research; pragmatic; primary care; self-management; urinary incontinence; women’s health.

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Figures

Figure 1.
Figure 1.
Flow diagram of participants in the URinControl trial. app=application; GP = general practitioner; POP-Q = pelvic organ prolapse quantification; UI=urinary incontinence.
Figure 2.
Figure 2.
Difference in change of ICIQ-UI-SF symptom score between groups. app = application; ICIQ-UI-SF = International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form; UI = urinary incontinence. Note: Difference in change of ICIQ-UI-SF symptom score: 0.058 (95% CI, –0.776 to 0.891). Change in symptom score with usual care minus change in symptom score with app-treatment. Dashed line at difference in change of 1.5 indicates noninferiority margin. Shaded region to the left of margin indicates values for which app-treatment would be considered noninferior to usual care. Dashed line at 0 represents null hypothesis. Analysis was performed on an intention-to-treat basis and adjusted for baseline scores. (The per-protocol analysis is shown in Supplemental Table 4, available at https://www.AnnFamMed.org/content/19/2/102/suppl/DC1/.)
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