Clinical trial NCT06291441: Women Urinary Incontinence Prevalence Study (WUIPS)
Official title: Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Female Urinary Incontinence
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Università Vita-Salute San Raffaele
First posted: 2024-03-04
Enrollment: 449
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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).

Brief summary: 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).

Detailed description: EXPECTED RESULTS

The collection of data and information through this study will aim to:

1. Understand the percentage of middle-aged women with UI.
2. Describe the socio-demographic and clinical characteristics of women with UI.
3. Identify UI predictors.
4. Describe the quality of life, social impact and costs of women with UI.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of middle-aged women with urinary incontinence
timeFrame: by December 2025
Secondary outcomes:
measure: Predictors of urinary incontinence in middle-aged women
timeFrame: by December 2025
measure: Quality of life of middle-aged women with urinary incontinence
timeFrame: by December 2025
measure: Social impact of middle-aged women with urinary incontinence
timeFrame: by December 2025
measure: Costs of urinary incontinence for middle-aged women
timeFrame: by December 2025
Other outcomes:
Locations:
city: Osio Sotto
country: Italy
facility: Policlinico San Marco Zingonia
state: Bergamo
city: Bergamo
country: Italy
facility: Policlinico San Pietro Ponte San Pietro
city: Milan
country: Italy
facility: San Raffaele Turro Hospital (MI)
city: Milan
country: Italy
facility: San Raffaele Hospital (MI)
Study officials:
affiliation: Director of Center for Nursing Research and Innovation (CeNRI)
name: Duilio F. Manara
role: STUDY_DIRECTOR
affiliation: U.O. Obstetrics and Gynecology
name: Stefano Salvatore
role: STUDY_DIRECTOR
affiliation: Director of U.O. Obstetrics and Gynecology
name: Massimo Candiani
role: STUDY_DIRECTOR
References: