About this trial
The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female sex
Middle age (40-65 years old)
Informed consent signed
Comprehension of written and spoken Italian language
Disqualifiers
Male sex
Young age (< 40 years) and older age (> 65 years)
Pregnant women
Puerperium women (up to 40 days post-partum)
Trial population
All female patients, female caregivers, female healthcare professionals and female administrative workers who meet the inclusion criteria will be included. Participants will be enrolled in four centers in Northern Italy which are the reference centers for UniSR: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG).
Trial design
Other
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention (observational study)
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of middle-aged women with urinary incontinence
Epidemiological data Measure: \- Italian version of International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI-SF)
Secondary outcomes
Predictors of urinary incontinence in middle-aged women
Description and association between UI and related predictors Measure: \- UI Survey: A part of the survey, written in Italian by the authors, will collect women's socio-demographic and clinical characteristics (predictors of UI)
Quality of life of middle-aged women with urinary incontinence
Description and association between UI and quality of life Measure: \- Italian version of Incontinence Impact Questionnaire-7 (IIQ-7) for investigating women's quality of life
Social impact of middle-aged women with urinary incontinence
Description and association between UI and social impact Measure: \- UI Survey: A part of the survey, written in Italian by the authors, will collect social impact of UI through a 4-point Likert scale
Costs of urinary incontinence for middle-aged women
Description of UI costs Measure: \- UI Survey: A part of the survey, written in Italian by the authors, will collect costs of UI through a 5-point Likert scale
Sponsors and contacts
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IRCCS San Raffaele
Lead sponsor
Università Vita-Salute San Raffaele
Collaborator