The burden of incontinence in a real-world data environment – insights from a digital patient companion (Preprint)

BACKGROUND Urinary Incontinence (UI) can have a potentially devastating effect on women’s quality of life (QoL) in the physical, social, sexual, and psychological spheres. During pregnancy and after delivery, the strength of the pelvic floor muscle may decrease, resulting in a high rate of UI. Conservative treatment by means of pelvic floor muscle training is the first-choice treatment modality. Nowadays, this can be supported by digital apps. Those apps have the advantage of giving insights into real-world data on UI. OBJECTIVE The aim of the present study was to analyze the impact of UI on QoL using the app pelvina. METHODS We analyzed data from pelvina - a digital health companion pelvic floor course. This course regularly examines incontinence symptoms through “The Questionnaire for Urinary Incontinence Diagnosis” (QUID) and QoL through SF-6D. Subsequently, we analyzed the incidence and degree of incontinence in a real-world environment and determined the influence of different demographic factors. In addition, the impact of UI on the QoL was evaluated in more detail. RESULTS In all, 293 patients with a median age of 36 years and a median of 2 deliveries could be included in this study. Patients were slightly to moderately affected by UI with a QUID of 6 (2 - 11, max: 24). Age and parity were independently associated with the incidence of UI with an adjusted odds ratio (aOR) of 1.06 (95% CI 1.01 – 1.12) and aOR of 1.86 (95% CI 1.12 – 3.08), respectively. The severity of incontinence symptoms strongly correlated with impairment in QoL ( = 0.489, P < 0.001). CONCLUSIONS The use of real-world data, as generated by digital health solutions such as pelvina, gives us, for the first time, the opportunity to gain insight into the reality of patients' lives outside of classical clinical studies. In this paper we can corroborate the known associations between parity and UI known from the literature and the great influence UI has on QoL on a daily basis. This study shows that, in the future, the use of digital apps can make an important contribution to scientific data acquisition and, for example, therapy monitoring.