Female Urinary Incontinence Clinical Trial
Official title:
Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
| Verified date | May 2024 |
| Source | IRCCS San Raffaele |
| Contact | Sara Trapani |
| Phone | 338 9879403 |
| trapani.sara[@]hsr.it | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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).
| Status | Not yet recruiting |
| Enrollment | 1842 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | June 28, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 40 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Policlinico San Pietro Ponte San Pietro | Bergamo | |
| Italy | San Raffaele Hospital (MI) | Milan | |
| Italy | San Raffaele Turro Hospital (MI) | Milan | |
| Italy | Policlinico San Marco Zingonia | Osio Sotto | Bergamo |
| Lead Sponsor | Collaborator |
|---|---|
| IRCCS San Raffaele | Università Vita-Salute San Raffaele |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00270738 -
Treatment for Female Stress Urinary Incontinence
|
N/A |