Randomized controlled trial in adult women with urinary incontinence comparing treatment delivered through a mobile application versus standard care.

BACKGROUND Urinary incontinence (UI) is a highly prevalent disorder in women. Despite available treatment options only 30% of women seek help for the problem. The availability of an easy-to-use, evidence based App for the treatment of UI may reduce the necessity of face-to-face contacts and increase continence rates and quality of life. Especially, the possibility to receive frequent reminders would enable patients to perform the necessary training, as forgetting is the most important reason why adherence can be lacking. This will help women with UI to have a better quality of life and it will considerably reduce health care costs.



OBJECTIVE To study the effects and cost-effectiveness of a App-based treatment program for women with urinary incontinence (UI) compared to standard care delivered by the general practitioner.



STUDY DESIGN AND POPULATION: Randomized controlled trial with non-inferiority design with non-pregnant women aged 18 years or older, who visit their general practitioner (GP) for symptoms of UI are eligible. They will be recruited from general practices in the northern part of the Netherlands.



INTERVENTION: The intervention consists of a treatment program on a mobile application for tablet or smartphone without face-to-face contact (App URinControl). The active control treatment is the standard care delivered by the GP



OUTCOME MEASURES: The primary outcome is the score on the International consultation on Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), which measures symptoms and impact of the UI on daily life. Secondary outcomes are the perception of improvement by the patient, number of UI episodes, condition- specific and generic health related quality of life sexual functioning and costs. Also, a process

evaluation will take place.

A treatment program for urinary incontinence (UI) in adult women delivered through a mobile application is not inferior to the standard way of treating patients, in primary care regarding its effects, it is less expensive and more cost-effective.

Three assessments will be performed, at baseline, after 4 months and after 12 months.

Intervention group: Mobile application (App)
After randomization patients will receive access to the
URinControl-App. In the App, basic information is provided in
a video fragment. Next, participants will learn how to use
their pelvic floor. Then the participants will start with a
training program tailored to their type of incontinence.
Women with stress (predominant) UI will start with pelvic
floor muscle training (PFMT); women with urgency
(predominant) UI will start with bladder training and PFMT
will be added later in the program. All exercises will be
supported by animations. All information will be available
through a bibliography within the app.
During the program patients are asked to fill out the number
of incontinence episodes, as well as the intensity with which
they performed the exercises. Treatment will be reinforced
by regularly sending 'push' notifications to stimulate
treatment adherence.
The content of the app is a translation of the
recommendations of the guidelines on the treatment of UI of
women in primary care. In the letter with instructions which will be advised to contact their general practitioner (GP) if
the progress of the treatment is unsatisfactory.

Control group: Standard Care
Patients in the standard care group will be diagnosed and
treated according to NHG-guideline on UI (PFMT in case of
stress UI, bladder training and PFMT for urgency UI). GP’s
can instruct patients themselves, or refer them to a practice
nurse or a specialized pelvic physiotherapist. In case of
urgency incontinence, they can also choose to prescribe
medication.