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| Name | Class |
|---|---|
| Università Vita-Salute San Raffaele | OTHER |
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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).
EXPECTED RESULTS
The collection of data and information through this study will aim to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women's single sample | INSTRUMENTS:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention (observational study) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | by December 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | by December 2025 |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Trapani | Contact | 338 9879403 | trapani.sara@hsr.it | |
| Giulia Villa | Contact | 0291751779 | villa.giulia@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Duilio F. Manara | Director of Center for Nursing Research and Innovation (CeNRI) | Study Director |
| Stefano Salvatore | U.O. Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico San Marco Zingonia | Recruiting | Osio Sotto | Bergamo | 24040 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2023 | Feb 15, 2024 | Prot_000.pdf |
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| 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 |
| by December 2025 |
| 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 | by December 2025 |
| 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 | by December 2025 |
| Massimo Candiani |
| Director of U.O. Obstetrics and Gynecology |
| Study Director |
| Policlinico San Pietro Ponte San Pietro | Recruiting | Bergamo | 24036 | Italy |
|
| San Raffaele Turro Hospital (MI) | Recruiting | Milan | 20127 | Italy |
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| San Raffaele Hospital (MI) | Recruiting | Milan | 20132 | Italy |
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