No intervention
OtherNo intervention (observational study)
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NCT Number: NCT06291441
Women Urinary Incontinence Prevalence Study (WUIPS)
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).
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Request InfoKey information
Conditions
Age range
40 year–65 year
Sex eligibility
Female
Study type
Observational
Primary location
Policlinico San Marco Zingonia, Osio Sotto, Bergamo, Italy
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About this study
EXPECTED RESULTS
The collection of data and information through this study will aim to:
- Understand the percentage of middle-aged women with UI.
- Describe the socio-demographic and clinical characteristics of women with UI.
- Identify UI predictors.
- Describe the quality of life, social impact and costs of women with UI.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Female sex
- Middle age (40-65 years old)
- Informed consent signed
- Comprehension of written and spoken Italian language
- Female outpatients intended for any hospital unit (outpatient clinic, day surgery and day hospital patients included) and every female caregiver respecting the previous inclusion criteria, recruited at the central admission and at the private admission of the four hospitals involved
- Female workers (healthcare professionals and administrative personnel) of the four hospitals
Exclusion criteria
- Male sex
- Young age (< 40 years) and older age (> 65 years)
- Pregnant women
- Puerperium women (up to 40 days post-partum)
- Women who had undergone urinary and gynecology surgery
Treatment and study plan
Primary outcomes
-
Prevalence of middle-aged women with urinary incontinence
Time frame: by December 2025
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
Time frame: by December 2025
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
Time frame: by December 2025
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
Time frame: by December 2025
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
Time frame: by December 2025
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
Study contacts
Contact information is provided by the study sponsor or research team.
Giulia Villa
CONTACT
Sara Trapani
CONTACT
Sponsors and collaborators
Lead sponsor
IRCCS San Raffaele
Other
Collaborators
- Università Vita-Salute San Raffaele
Registry information
Official study title
Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Mar 4, 2024
- Registry last updated
- Sep 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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