Hypothesis / aims of study
Hypothesis / aims of study: Our hypothesis is that users of Continence App® will present an adequate knowledge rate on urinary incontinence (UI) higher than that of women in the control group. Therefore, we aimed to evaluate the effectiveness of using the Continence App® to increase rates of adequate knowledge about urinary incontinence.
Study design, materials and methods
Study design, materials, and methods: A two-arm unblinded parallel randomized controlled trial performed with 102 (CG: 55; GI: 47) puerperal women that had vaginal delivery at term in a maternity hospital. CONSORT-EHEALTH [1] was used as the methodological reference. Postpartum women with a smartphone compatible with the application were included. Those who gave birth to infants who were small for gestational age, those who did not know how to read and those who referred UI prior to the last pregnancy were excluded. Women were discontinued from the study if we were not able to reach a telephone contact after three attempts to assess knowledge. Preliminary data analysis was performed with 63.2% (n = 86) of data collected from an ongoing clinical trial, which has 136 women as its final goal. After signing the consent form, participants were randomized according to a list previously prepared with the help of the website randomization.com. The intervention group (IG) received, even during hospitalization, in person, access to the Continence App® on their smartphones, for fully electronic and free use, for a minimum of 13 weeks. The application was built and validated by the authors of the present study, based on the Health Belief Model, consisting of four information cards that address the anatomy and function of the pelvic structures, risk factors, concepts, types of UI, forms of prevention and a Pelvic Floor Muscle Training (PFMT) program [2]. The control group (CG) received routine care from the institution, including a visit by a physical therapist to teach PFMT. The improvement in knowledge was measured from the use of only the ten questions related to the knowledge of the KAP-UI scale (Knowledge, Attitude and Practice on UI). These questions address knowledge about symptoms (Q1), risk factors (Q2, Q4, Q5 and Q6), UI severity (Q3) and ways of prevention (Q7 and Q8) and treatment (Q9 and Q10). Each question has a score ranging from 0 to 20, totaling a maximum of 100 points. The higher the score, the greater the woman's knowledge about UI [3]. The secondary outcome was the presence of UI measured using the International Consultation on Incontinence Questionnaire -Short Form (ICIQ-SF). Identification and knowledge assessment data on UI were collected in person at baseline and by phone three months later (time required to complete the Continence App® training program). Data analysis was performed with the intention of using the T test for paired samples and Mam-Whitney, with 95% confidence intervals.
Results
Results: The study participants (n = 86 / IG = 38 / CG: 48) were mostly young (M: 26.2 ± 6.0), with an average of ten years of study (M: 10.8 ± 2.5), monthly income of 289.85 ± 130.86 USD, without paid work (n = 45 / 52.3%), living with a partner (n = 70 / 81.4%), with an average of 1.8 ± 1.0 childbirths, most of them vaginal deliveries (M: 1.7 ± 1.0). Most women denied loss of urine (n = 50 / 58.1%; CG: 29 / 60.4%; IG: 21 / 55.3%; p = 0.869). The groups did not differ in terms of socio-demographic, gynecological-obstetric or clinical characteristics at baseline (p> 0.05). The initial knowledge assessment was similar between groups (IG: 50.0 ± 22.4 / CG: 54.6 ± 22.3; p = 0.261). Although practically all women have heard about UI (IG: 38/100%; CG: 47 / 97.9%), the questions with the lowest percentage of correct answers were about prevention (Q8 = min: 22.9% -max: 28.9%), risk factors (Q5 and Q6 = min: 36.8% - max: 43.7%), treatment (Q10 = min: 31.5% -max: 54.1%) and UI severity (Q3 = min: 45.8% -max: 52.6%). Both groups showed percentages below 50% in four questions during the initial assessment. In the outcome, 33.3% / n = 16 of women in the IG and 16.3% / n = 09 of the CG reported losing urine, most of them lost in small or moderate amounts (31.2% / n = 15 in the IG and 16.4% / n = 9 in the CG). The knowledge of women in the IG increased (baseline: 50.0 ± 22.4 / outcome: 67.7 ± 28.7; p = 0.000) and that of women in the CG remained unchanged (baseline: 54.6 ± 22.3 / outcome: 52.5 ± 22.8; p = 0.532). Women in the CG continued to present percentages below 50% in four questions about: risk factors for UI (Q5 and Q6), prevention (Q8) and treatment (Q10). Women in the IG only presented a percentage of less than 50% in one question (Q5) about the risk factor for UI in the outcome. The knowledge of women in the IG (outcome: 67.7 ± 28.7) was higher than that of women in the CG (outcome: 52.5 ± 22.8) (p = 0.018).
Interpretation of results
Interpretation of results: The educational intervention mediated by the Continence App® application, built and validated according to the Health Belief Model, with information recommended by the International Continence Society and International Urogynecological Association, proved to be effective as a technology to improve women's knowledge after childbirth on UI in the preliminary analysis.