RUTI-FREEDOM: Recurrent Urinary Tract Infections in Females Receiving Effective Education, Digital Outreach & Management - a multicenter prospective randomized controlled trial in the Netherlands

Recurrent urinary tract infections (rUTIs) rank among the most prevalent
bacterial infections globally. In the Netherlands, approximately 20,000 women
are referred to urologists for this condition annually. Our previous research
demonstrated that these referrals have limited added value, despite high
expectations. The Dutch Healthcare Institute (Zorginstituut Nederland or ZIN)
outlines three pillars for improving care for this patient group in the
"Verbetersignalement Urineweginfecties" (2021): enhancements in decision-making
through shared decision-making, reduction of unnecessary diagnostics, and
minimizing antibiotic usage. ZIN reports that many patients are willing to wait
for spontaneous recovery from an infection but are often unaware of this
possibility. Additionally, our own research reveals that 25% of women lack
awareness, and 50% have limited knowledge of preventive measures. The
majority express a need for more information about their condition and
preventive treatment options. While a greater information supply could improve
patient knowledge, it proves challenging for healthcare providers to deliver
and for patients to retain in practice. There is a lack of access to
information for patients, insufficient time for counseling, and a shortage of
healthcare providers. Digital coaching may provide a solution to address these
deficiencies.

A pilot study on digital coaching in rUTI at the Urology Department of Isala
tested an app-based treatment additional to standard care.[8] The app provides
information on rUTI aetiology, lifestyle recommendations, treatments, and the
value of additional diagnostics. Besides interactive education, the app
establishes a digital communication channel with the hospital, demonstrating
increased patient knowledge and positive lifestyle changes. Patients were very
content with the additional accompaniment for their condition.
The efficacy of app-based rUTI treatment in reducing diagnostics, hospital
visits, and antibiotic usage remains uncertain. This randomized controlled
trial (RCT) seeks to ascertain whether app-based intervention enhances rUTI
healthcare compared to standard Dutch care.

: Multicenter Randomized Controlled Trial in women suffering from rUTI.
Patients will be randomized in a 1:1-ratio to either intervention group or
control group. Total follow-up will entail 12 months.

Participants in the intervention group will have access to a digital
application, which enables patients to educate themselves, to monitor their
symptoms and lifestyle, to assess their symptoms by filling in a digital
questionnaire and to contact the outpatient clinic. Access to this application
is provided as an addition to the care as usual from the urology outpatient
departments, which is the same care as usual in both the intervention group and
the control group.

Participating in the study requires a time-investment from patients. Patients
in the intervention group will be asked to complete a series of educational
e-learnings. Also, they will be asked to complete a bi-monthly digital
questionnaire. Furthermore, all participants will be asked to complete several
questionnaires at 4 months, 8 months and 12 months. The risks for participating
are minimal due to the additional nature of the intervention.