The burden of incontinence in a real-world data environment—insights from a digital patient companion
verfasst von:
Alexandra von Au, Stephanie Wallwiener, Lina Maria Matthies, Benjamin Friedrich, Sabine Keim, Markus Wallwiener, Christl Reisenauer, Sarah Brugger
The 293 patients included in this study had a median age of 36 years and a median of two children. Patients were slightly to moderately affected by UI with a QUID of 6 (2–11, maximum 24). Age and number of children 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). The severity of UI strongly correlated with impairment of QoL (ρ = 0.866, P < 0.001).
Conclusions
The use of real-world data generated by digital health solutions offers the opportunity to gain insight into the reality of patients’ lives. In this article, we corroborate the known associations between number of children and UI as well as the great influence UI has on QoL. 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.
Hinweise
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Introduction
Pelvic floor dysfunction (PFD) or pelvic floor disorders are general terms used to describe conditions that compromise the female continence mechanism (urinary and fecal) and/or pelvic organ support. It is common in women, especially with advancing age [1]. Pelvic floor integrity is maintained by the coordinated actions of muscles (e.g., levator ani and urethral and anal sphincters), nerves (sacral plexus and pudendal nerve), and connective tissue (e.g., endopelvic ‘fascia’, perineal body) anchored to the bony pelvis [2]. Pelvic floor muscle function can be qualitatively defined by muscle tone at rest and the strength of a voluntary or reflex contraction as strong, normal, weak, or absent [3]. The definition of PFD in women is usually limited to include only urinary incontinence (UI) and pelvic organ prolapse (POP). However, atrophic changes in the lower urinary tract can lead to restrictions in sexual function, dysuria (painful or difficult urination), and recurrent genitourinary tract infection as well [4]. UI can be divided into stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). In SUI, physical exertion can be associated with urinary loss. Increased intra-abdominal pressure triggered by physical exertion increases intravesical pressure, and if it exceeds the intraurethral pressure in the absence of contraction of the detrusor muscle, the resulting urinary leakage is referred to as SUI. Thus, SUI is the complaint of involuntary urine loss on effort or physical exertion (also on sneezing or coughing) while UUI is the complaint of involuntary loss of urine associated with urgency [5]. Mixed forms of incontinence often occur and aggravate diagnosis and therapeutic concepts. According to different studies, UI has a devastating effect on women’s quality of life (QoL) in the physical, social, sexual, and psychological spheres [6]. Women restrict or diminish their activity and social participation, which has serious implications [7].
While UI is common in elderly women, also younger women can suffer from it. During the second and third trimesters of pregnancy and in the first 3 months following childbirth, about one-third of women experience UI [8]. During pregnancy and after delivery, the strength of the pelvic floor muscle (PFM) may decrease as a result of hormonal and anatomical changes (in both the position of the pelvis and the shape of the PFM), facilitating musculoskeletal alterations that can lead to UI. The overall prevalence (all types of UI) during pregnancy is estimated to be around 58%, and SUI affects about 31–42% of either childless women (nulliparous) or women with children (multiparous) [9]. In clinical practice, nonsurgical therapies are usually tried first because they are likely to carry the least risk of harm. The EAU Guidelines for Urinary Incontinence in Adults recommends supervised intensive pelvic floor muscle training (PFMT), lasting at least 3 months, as a first-line therapy for all women with SUI or mixed urinary incontinence (including the elderly and postpartum patients) [3]. However, as the topic of UI is embarrassing for most women even when talking to health care personnel, treatment options frequently are not carried out or are canceled prematurely by the patients [3].
Furthermore, in each block of the course the participants are asked to fill out the Questionnaire for Urinary Incontinence Diagnosis (QUID), a six-item UI symptom questionnaire that was developed and validated to distinguish and evaluate stress and urgency UI [15]. Three items focus on stress incontinence symptoms and three on urge incontinence symptoms. Each item includes six frequency-based response options, ranging from “none of the time” to “all of the time,” which are scored from 0 to 5 points. Scores are calculated in an additive fashion, resulting in separate stress and urge scores, each ranging from 0 to 15 points. Therefore, a grading between 0 and 30 scale points is possible, with larger numbers indicating a greater severity of incontinence symptoms.
Additionally, the QoL of the patients was analyzed in every block of the course using the SF-6D, a well-established six-item QoL outcome measure [16]. Results from 0 to 30 are possible, with larger numbers indicating a larger impairment of QoL.
Statistical analysis was performed using SPSS 25 (IBM, Armonk, NY, USA). Correlation between the various parameters was assessed using Spearman’s ρ correlation. The difference between the rate of previous knowledge about pelvic floor insufficiency and the number of births was analyzed using ANOVA for ranking followed by a Tukey post-hoc analysis with bootstrapping with 10,000 permutations. After univariate analysis by a Mann-Whitney U test, a multivariate logistic regression analysis was performed to test the association between age and number of children on the incidence of incontinence. All data are presented as median (interquartile range) if not indicated differently. Results derived from the logistic regression analysis are shown as the adjusted odds ratios (aOR) and respective 95% confidence intervals (95% CI). Statistical significance was assumed at P < 0.05.
Results
Patient characteristics
A total of 293 patients fulfilled all the previously defined inclusion criteria (Fig. 1). The median age was 36 years, and the patients had given birth to two children on the median. Sixteen percent of the patients (n = 47 of 293 patients) reported comorbidities, e.g., a history of cancer or diabetes mellitus, and 25% of the patients (n = 73 of 293 patients) reported regular medication usage. In those cases, hormone therapy was most often used, with 12% of the patients (n = 35 of 293 patients) taking some form of regular hormone therapy (either contraceptive or hormone replacement therapy). Furthermore, 4.4% of the patients indicated that they were taking antihypertensive medication and 2.7% of the patients that they were taking regular medication for asthma. We were therefore able to indirectly conclude that the corresponding patients suffered from arterial hypertension or asthma (see Table 2).
Furthermore, we analyzed the impact of incontinence on QoL in a real-world setting using the SF-6D. There was a significant positive correlation between the severity of incontinence symptoms expressed by the QUID score and restrictions in QoL (ρ = 0.866, P < 0.001) (Fig. 5). This association was also true for symptoms from both the area of stress incontinence and urgency incontinence (QUIDstress: ρ = 0.509, P < 0.001; QUIDurge: ρ = 0.333, P < 0.001). Furthermore, there was a clear association between number of children and the rate of prior knowledge regarding the pelvic floor. While nulliparous women only had previous knowledge about the pelvic floor in 25% of the cases, general knowledge about the role of the pelvic floor rose to 46.4% after the third child (P = 0.014, Fig. 6).
Thus, the analysis of digitally collected real-world data confirms the published literature on incontinence and its influence on the QoL.
Traditional studies—whether observational studies or other study designs—have defined modern medicine and paved the way for evidence-based development. However, these classical studies are not without problems and difficulties as they suffer from restrictions.
Benjamin Friedrich works as a paid consultant for Temedica. There are no other financial conflicts of interest.
All other authors declare that they have no conflict of interest.
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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