Women Urinary Incontinence Prevalence Study (WUIPS)

NCT ID: NCT06291441

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

449 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-03

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Female Urinary Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

No intervention

Intervention Type OTHER

No intervention (observational study)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention (observational study)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Female sex
* Middle age (40-65 years old)
* Informed consent signed
* Comprehension of written and spoken Italian language
* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Università Vita-Salute San Raffaele

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sara Trapani

Principal Investigator, Midwife (RM), PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duilio F. Manara

Role: STUDY_DIRECTOR

Director of Center for Nursing Research and Innovation (CeNRI)

Stefano Salvatore

Role: STUDY_DIRECTOR

U.O. Obstetrics and Gynecology

Massimo Candiani

Role: STUDY_DIRECTOR

Director of U.O. Obstetrics and Gynecology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Policlinico San Marco Zingonia

Osio Sotto, Bergamo, Italy

Site Status RECRUITING

Policlinico San Pietro Ponte San Pietro

Bergamo, , Italy

Site Status RECRUITING

San Raffaele Turro Hospital (MI)

Milan, , Italy

Site Status RECRUITING

San Raffaele Hospital (MI)

Milan, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sara Trapani

Role: CONTACT

338 9879403

Giulia Villa

Role: CONTACT

0291751779

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Elisabetta Bagnato

Role: primary

Giulia Villa

Role: backup

0291751779

Elisabetta Bagnato

Role: primary

Giulia Villa

Role: backup

0291751779

Sara Trapani

Role: primary

+39 3389879403

Giulia Villa

Role: backup

0291751779

Sara Trapani

Role: primary

+39 3389879403

Giulia Villa

Role: backup

0291751779

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WUIPS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PFU vs. UDS in SUI
NCT06886997 NOT_YET_RECRUITING
Tele-rehabilitation for Women With Urinary Incontinence
NCT06161324 ENROLLING_BY_INVITATION NA
Prevent Inability To Control Urination
NCT00075114 COMPLETED PHASE3