NCT06291441

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
449

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

February 16, 2024

Last Update Submit

September 14, 2024

Conditions

Female Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Predictors of urinary incontinence in middle-aged women

    by December 2025

  • Quality of life of middle-aged women with urinary incontinence

    by December 2025

  • Social impact of middle-aged women with urinary incontinence

    by December 2025

  • Costs of urinary incontinence for middle-aged women

    by December 2025

Study Arms (1)

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)

Other: No intervention

Interventions

No interventionOTHER

No intervention (observational study)

Women's single sample

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Policlinico San Marco Zingonia

Osio Sotto, Bergamo, 24040, Italy

RECRUITING

Policlinico San Pietro Ponte San Pietro

Bergamo, 24036, Italy

RECRUITING

San Raffaele Turro Hospital (MI)

Milan, 20127, Italy

RECRUITING

San Raffaele Hospital (MI)

Milan, 20132, Italy

RECRUITING

Study Officials

  • Duilio F. Manara

    Director of Center for Nursing Research and Innovation (CeNRI)

    STUDY DIRECTOR

  • Stefano Salvatore

    U.O. Obstetrics and Gynecology

    STUDY DIRECTOR

  • Massimo Candiani

    Director of U.O. Obstetrics and Gynecology

    STUDY DIRECTOR

Central Study Contacts

Sara Trapani

CONTACT

338 9879403trapani.sara@hsr.it

Giulia Villa

CONTACT

0291751779villa.giulia@hsr.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Midwife (RM), PhD student

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 4, 2024

Study Start

July 3, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(4)