Female Urinary IncontinenceNCT06291441
Women Urinary Incontinence Prevalence Study (WUIPS)
An observational study of Female Urinary Incontinence, run by IRCCS San Raffaele at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Urinary Incontinence
- How many people
- 449 participants
- Where
- 4 sitesItaly
- Study dates
- 3 Jul 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Policlinico San Pietro Ponte San Pietro
Bergamo, 24036
Elisabetta Bagnato, elisabetta.bagnato@grupposandonato.it
Giulia Villa, 0291751779, villa.giulia@hsr.it
- Recruiting
San Raffaele Turro Hospital (MI)
Milan, 20127
Sara Trapani, +39 3389879403, trapani.sara@hsr.it
Giulia Villa, 0291751779, villa.giulia@hsr.it
- Recruiting
San Raffaele Hospital (MI)
Milan, 20132
Sara Trapani, +39 3389879403, trapani.sara@hsr.it
Giulia Villa, 0291751779, villa.giulia@hsr.it
- Recruiting
Policlinico San Marco Zingonia
Osio Sotto, Bergamo, 24040
Elisabetta Bagnato, elisabetta.bagnato@grupposandonato.it
Giulia Villa, 0291751779, villa.giulia@hsr.it
About this study
Official title: Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
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).
Read the detailed description
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.
- Conditions
- Female Urinary Incontinence
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention (observational study)
| Study group | Role | What they receive |
|---|---|---|
| Women's single sample | INSTRUMENTS:
* UI Survey: A survey, written in Italian by the authors, will collect women's socio-demographic, economic and clinical characteristics
* Italian version of International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI-SF)
* Italian version of Incontinence Impact Questionnaire-7 (IIQ-7) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: by December 2025
Secondary outcomes (4)
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)
Measured: by December 2025
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
Measured: 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
Measured: 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
Measured: by December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 449 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Responsible party
- Principal investigator, Sara Trapani, IRCCS San Raffaele
- Investigators
- Duilio F. Manara, Study director, Director of Center for Nursing Research and Innovation (CeNRI)Stefano Salvatore, Study director, U.O. Obstetrics and GynecologyMassimo Candiani, Study director, Director of U.O. Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291441
- Sponsor's protocol ID
- WUIPS
- Status last verified
- Sep 2024
- First submitted
- 16 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
- ClinicalTrials.gov ID
- NCT06291441
- Acronym / sponsor ID
- WUIPS
- Conditions
- Female Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 449 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Università Vita-Salute San Raffaele
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women's single sample | – | Other: No interventionINSTRUMENTS: * UI Survey: A survey, written in Italian by the authors, will collect women's socio-demographic, economic and clinical characteristics * Italian version of International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI-SF) * Italian version of Incontinence Impact Questionnaire-7 (IIQ-7) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention (observational study) | Other | Women's single sample |
Primary outcome
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)
4 secondary outcomes
Predictors of urinary incontinence in middle-aged women
Time frame: by December 2025
Quality of life of middle-aged women with urinary incontinence
Time frame: by December 2025
Social impact of middle-aged women with urinary incontinence
Time frame: by December 2025
Costs of urinary incontinence for middle-aged women
Time frame: by December 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duilio F. Manara study director
Director of Center for Nursing Research and Innovation (CeNRI)
Stefano Salvatore study director
U.O. Obstetrics and Gynecology
Massimo Candiani study director
Director of U.O. Obstetrics and Gynecology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Urinary Incontinence, run by IRCCS San Raffaele at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Trapani (338 9879403, trapani.sara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of middle-aged women with urinary incontinence (time frame: by December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.