Female Urinary Incontinence in Middle-aged Women in Four Hospitals in Northern Italy: a Multicenter Prevalence Study
Conditions: Female Urinary Incontinence
Sponsor: IRCCS San Raffaele

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STUDY PROTOCOL – DO NOT COPY OR DISTRIBUTE 
Title:  Female Urinary Incontinence in middle-aged women in four hospitals in Northern Italy: a multicenter 
prevalence study 
Protocol Acronym: WUIPS (Women Urinary Incontinence Prevalence Study) 
Version and date: Version n. 1, 23.08.2023 
Principal Investigator (PI) 
Dott.ssa Sara Trapani 
E-mail: trapani.sara@hsr.it 
338 9879403 
Co-Principal Investigator (CO-PI) 
Prof. Stefano Salvatore 
Prof. Duilio F. Manara 
Sponsor 
IRCCS San Raffaele Hospital 
Authorized Sponsor Representative 
Massimo Candiani 
Director  
U.O. of Obstetrics and Gynecology 
IRCCS Ospedale San Raffaele 
Coordinator Center:  
San Raffaele Hospital, Milan 
Centers: 
Ospedale San Raffaele Turro, Milan  
Policlinico San Pietro, Ponte San Pietro (BG) 
Policlinico San Marco, Zingonia (BG) 
Expected duration of the study:  
6 months 
 
Research Team:  
Sara Trapani 
IRCCS Ospedale San Raffaele 
Principal Investigator (PI) 
Stefano Salvatore 
IRCCS Ospedale San Raffaele 
Vita Salute San Raffaele University 
Co-Principal Investigator (CO-
PI) 
Duilio Fiorenzo 
Manara  
Vita Salute San Raffaele University 
Co-Principal Investigator (CO-
PI), Supervisor 
Elisabetta Bagnato 
Policlinico San Pietro - Istituti Ospedalieri 
Bergamaschi 
Associate Investigator 
Stefania Rinaldi 
IRCCS Ospedale San Raffaele 
Vita Salute San Raffaele University 
Associate Investigator 
Martina Caglioni 
IRCCS Ospedale San Raffaele 
Associate Investigator 

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Giulia Villa 
Vita Salute San Raffaele University 
Associate Investigator, 
Supervisor 
Massimo Candiani 
IRCCS Ospedale San Raffaele 
Vita Salute San Raffaele University 
Associate Investigator, 
Supervisor 
 
SIGNATURE PAGE 
Title:  Female Urinary Incontinence in middle-aged women in four hospitals in Northern Italy: a multicenter 
prevalence study 
 
The undersigned has read and understands all aspects of the protocol detailed in this document and agrees 
to supervise and conduct the study in accordance with the protocol, the ICH E6 (R2) Good Clinical Practice 
Guidelines, the Declaration of Helsinki and all the applicable regulatory requirements.  
 
 
 
 
 
 
Conflicts of interest 
The authors declare that the research was conducted in the absence of any commercial or financial relationships that 
could be construed as a potential conflict of interest.  
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the Sponsor, the 
Investigator Team, host organisation, and members of the Research Ethics Committee, unless authorised to do so. 
 
Massimo Candiani 
 
 
 
IRCCS Ospedale San 
Raffaele 
 
25/11/2023 
Authorized Sponsor 
Representative 
Name 
 
 
Signature 
 
Affiliation 
 
Date 
Sara Trapani 
IRCCS Ospedale San 
Raffaele 
23/08/2023 
PRINCIPAL 
INVESTIGATOR 
 
Signature 
Affiliation 
Date 

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TABLE OF CONTENTS 
1. RATIONALE OF THE STUDY 
4 
2. STUDY DESIGN 
5 
3. OBJECTIVE 
5 
4. OUTCOMES 
5 
5. EXPECTED RESULTS 
6 
6. STUDY POPULATION 
6 
7. INCLUSION/EXCLUSION CRITERIA 
6 
7.1 Inclusion criteria 
6 
7.2 Exclusion criteria 
6 
8. PARTICIPANT REGISTRATION 
7 
9. DATA COLLECTION 
7 
9.1 Instruments 
11 
9.1.1 UI Survey 
12 
9.1.2 International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short 
Form (ICIQ UI-SF) 
12 
9.1.3 Incontinence Impact Questionnaire-7 (IIQ-7) 
 
 
 
 
 
    13 
10. DATA MANAGEMENT AND QUALITY CONTROL 
13 
11. NUMBER OF CASES 
13 
12. SUBJECT'S POTENTIAL RISKS AND BENEFITS 
14 
12.1 Bias risk 
14 
13. STATISTICAL ANALYSES 
15 
14. ETHICAL ASPECTS 
15 
15. PARTICIPANT INFORMATION AND CONSENT 
16 
16. DATA QUALITY, DATABASE MANAGEMENT 
16 
16.1 Data confidentiality and privacy 
16 
16.2 Data ownership 
17 
17. DATA PUBLICATION 
17 
18. CONSERVATION OF STUDY DOCUMENTS 
17 
19. FINANCIAL ARRANGEMENTS 
18 
20. REFERENCES 
18 
APPENDIX 
23 
 
 

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1. RATIONALE OF THE STUDY  
Bladder problems and urinary diseases, also known as Lower Urinary Tract Symptoms (LUTS), are 
common worldwide (Todhunter-Brown et al., 2022). One of these problems is Urinary Incontinence (UI), 
defined as “the complaint of any involuntary leakage of urine” (Abrams et al., 2003; Hylen et al., 2010). UI 
can be classified into three main subtypes. Stress UI (SUI) is the urine loss provoked by exertion, physical 
effort, sneezing or coughing; Urge UI (UUI) refers to urine leakage accompanied by a sense of urgency that is 
defined as a sudden and compelling desire to void urine (Haylen et al., 2010; Bo et al., 2017); Mixed UI 
consists of the combination of SUI and UUI (Abrams et al., 2003).  
UI has been identified as a World Health Organization health priority (Parpio, Minaz & Haider, 2022), 
also because individuals with UI are projected to increase with time, with the greatest increase in burden 
anticipated in developing regions (Irwin et al., 2011). A worldwide prevalence study conducted in the last 
decade reported that an estimated 21.5% of the 2008 worldwide population ≥ 20 years (approximately 348 
million subjects out of 4.3 billion) was affected by UI (Irwin et al., 2011). Particularly, SUI is the most common 
UI type (5.9% in women vs 0.49% in men in 2008). Numbers of patients affected by UUI in 2008 were 49 
million, while 54 million individuals were affected by MUI (Irwin et al., 2011).  
Currently, the Italian epidemiology for UI is approximately 5 million people (the 8,7% of the 
population), of which 3 million are women (Fincopp, 2022). According to the Italian Institute for Statistics 
(ISTAT), the Italian population is aging, and the average age of the population ranges between 40 and 65 
years old (Sistema Statistico Italiano and Istituto Nazionale di Statistica (ISTAT), 2021). Statistics suggest 
focusing on this specific range of age, in which population’s high quality of life and healthy lifestyle is 
expected, also because they are socially active subjects. In addition, the range 40-65 represents the starting 
point of significant occurrence of UI in the female population (Irwin et al., 2006; Wieland et al., 2019; Fincopp, 
2022). In fact, a study conducted in an Italian urban area (Siracusano et al., 2003), investigating the UI 
prevalence by age subgroups in a sample of 2900 women, showed that more than one in four women 
suffered from incontinence episodes from 40 years of age onwards. Another Italian prevalence study 
(Bortolotti et al., 2000) interviewed 2767 women ≥ 40 years old and 2721 men ≥ 50 years old to assess the 
frequency of UI, finding that 3% of male sample and 11% of female participants reported at least one episode 
of UI during the previous year. Female data were substantially confirmed by an Italian cross-sectional study 
carried out in 2002 (Parazzini, Lavezzari & Arbitani, 2002). A total of 13365 women (mean age, 60.3 years) 
were identified by 774 general practitioners: the frequencies of UI were 10.2%. Instead, for men older than 
40 years (mean 64.8 years) a fairly higher percentage than in previous data (8.3% vs 3%) experienced UI 
(Parazzini, Lavezzari & Arbitani, 2002). This discrepancy is probably linked to the fact that, in the study by 
Bortolotti and colleagues, men between the ages of 40 and 50 were not enrolled (Miano et al., 2012).  
Regarding gender difference, UI affects both women (Sussman et al, 2020) and men (Gacci et al., 
2022), but it is more common in female than in male population (Markland et al., 2011; Milsom & Gyhagen, 
2019; Monticone et al., 2020) and women are more severely affected than men (Aslan et al., 2008), due to 
obstetric, gynecological and hormonal causes (Sensoy et al., 2013): these data highlight the importance of 
the phenomenon and the need to study in depth the female UI condition.  
In addition, UI negatively influences the physical, psychological, social and financial life of the 
affected people (Batmani et al., 2021; Parpio, Minaz & Haider, 2022). The health-related quality of life impact 

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of incontinence is similar to that observed with other chronic medical conditions like osteoarthritis, chronic 
obstructive pulmonary disease, and stroke (Subak et al., 2006). Specifically, it was seen that UUI is the UI 
subtype with the higher impact on the quality of life (Aslan et al., 2009), due to the frequency of incontinence 
episodes and the urge to urinate, which interrupts the daily routine. Reducing these symptoms is a priority 
for women and it is demonstrated by their willingness to pay for continence improvement (Subak et al., 
2006). In fact, women with UI consume significantly higher medical resources and incur higher costs to 
payers, compared to women without this problem (Datar et al., 2022).  
Although it is a widely discussed literature topic, UI is an underestimated condition (Tran & Puckett, 
2022). In fact, sometimes people do not report this problem, because it is still considered a taboo and a 
source of shame and embarrassment (Elenskaia et al., 2011). In addition, the last published Italian prevalence 
studies date back to the first decade of the new millennium (Bortolotti et al., 2000; Parazzini, Lavezzari & 
Arbitani, 2002; Siracusano et al., 2003). For this reason, a prevalence study focused on UI in Italy could 
provide significant information. 
The current study will indagate the prevalence, predictors and effects (quality of life and costs) of UI 
in middle-aged women (40-65 years old) identified in four hospitals in Northern Italy, which are the reference 
centers for Vita-Salute San Raffaele University (UniSR).  
 
2. STUDY DESIGN  
A multicenter prospective and prevalence observational study will be conducted. A prevalence study 
is essential for establishing the distribution of the condition in the population and projecting the need for 
health and medical services supporting health care professionals to make preventive and treatment 
decisions. The study will follow the STrengthening the Reporting of OBservational studies in Epidemiology 
(STROBE) Checklist (Vandenbroucke et al., 2007). 
3. OBJECTIVE 
The study will aim to punctually investigate and describe prevalence, predictors, quality of life and 
costs of Urinary Incontinence among female patients, female caregivers and female personnel in four 
hospitals in Northern Italy.  
4. OUTCOMES 
Primary outcome 
- 
Prevalence of middle-aged women with urinary incontinence. 
Secondary outcomes 
- 
Description of UI and related predictors, quality of life, social impact and costs. 
- 
Association between UI and related predictors, quality of life, social impact and costs. 
 
5. EXPECTED RESULTS 
The collection of data and information through this study will aim to: 
a) Understand the percentage of middle-aged women with UI. 

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b) Describe the socio-demographic and clinical characteristics of women with UI. 
c) Identify UI predictors. 
d) Describe the quality of life, social impact and costs of women with UI. 
 
6. 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).  
 
7. INCLUSION/EXCLUSION CRITERIA 
7.1 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 
7.2 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  
 
8. PARTICIPANT REGISTRATION  
Data collection will be carried out through the use of two questionnaires validated in Italian language 
and a survey built by the researchers on the basis of the scientific literature.  
Two different paths have been designed to recruit participants, depending on whether they are 
female personnel or female patients and female caregivers:  

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- 
for healthcare professionals and administrative workers of the four hospitals, one week before the 
administration of the data collection tools (a survey and two validated questionnaires), an email will 
be sent to the work account to present the topic and the aim of the study. A second email will then 
be sent with a link to access the online survey/questionnaires (RedCap) and with a deadline by which 
to fill it out. The email will be sent to all workers, asking for the compilation only to women of 40-65 
age range group and who meet the inclusion criteria. Participants will agree to a brief privacy policy 
and electronic release of informed consent before completing the survey and the questionnaires.  
- 
for female patients and female caregivers’ registration, participants will be recruited at the central 
admission and at the private admission of four hospitals in Northern Italy. At recruitment, inclusion 
and exclusion criteria will be evaluated through a brief preliminary interview, lasting about a couple 
of minutes. It will take place immediately before the administration of the questionnaires at the 
central and private reception of the hospitals involved. On this occasion, a researcher in charge of 
data collection will ask the participant for information on: age, pregnancy/puerperium status and 
past history of gynecological surgery. Each participant who joins the study will be provided with a 
paper module, containing the survey and the questionnaires, marked with a progressive 
identification number: after signing the informed consent, all participants will be asked to answer 
questions voluntary and anonymously at the moment and return the completed module to 
researchers.  
Data will be collected anonymously by a paper module for patients and caregivers and by RedCap for 
healthcare professionals and administrative workers. Then, the data on the platform will be extracted to 
the eCRF; the paper data will be uploaded to the eCRF by the researchers.  
9. DATA COLLECTION 
All the data will be collected based on a series of variables which derive from an accurate narrative 
review of the UI predictors, costs and quality of life of the women affected by the problem (Danforth et al., 
2006; Datar et al., 2022; Goren et al., 2014; Harding et al., 2023; Sensoy et al., 2013). These variables are 
described in Table 1. The obtained information will be gathered in the eCRF, which the investigators will only 
access during the analyses and synthesis of data.  
 
Table 1 - Outcome and description of the investigated variables 
OUTCOME 
VARIABLE 
DESCRIPTION 
UI predictors 
Age  
The prevalence of UI seems strongly related to the age of the 
woman and specifically prevalence figures increase with 
increasing age (Milsom & Gyhagen, 2019) 

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Ethnicity 
The risk of SUI appears to be lower in black and Asian-
American women compared to white women (Danforth et 
al., 2006; Thom et al., 2006) 
Scholarship 
According to some studies (Batmani et al., 2021; Marques et 
al., 2015), increasing the level of education is an important 
factor in reducing the incidence of urinary incontinence  
Body Mass Index 
(BMI) 
There is evidence that the prevalence of both UUI and SUI 
increases proportionately with BMI (Harding et al., 2023) 
Comorbidities 
Lower urinary tract symptoms are associated with multiple 
comorbid conditions including: 
• cardiac failure 
• chronic renal failure 
• chronic obstructive pulmonary disease 
• diabetes 
• hypertension 
• metabolic syndrome 
• pelvic organs prolapse 
• urinary tract infections 
• bowel disorders (constipation, irritable bowel syndrome) 
• sleep disturbances 
• depression 
• neurological disease 
• general cognitive impairment  
(Batmani et al., 2021; Harding et al., 2023; Sensoy et al., 
2013; Wang et al., 2010) 
Pelvic or uro-
gynecological 
surgery 
Other factors positively associated with SUI include previous 
pelvic or uro-gynecological surgery (Ellström Engh et al., 
2006; Harding et al., 2023) 

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Menopause 
Menopausal status seems to influence the onset and 
characteristics of urine leakage (Sensoy  et al., 2013; 
Thangarajah et al., 2020) 
Parity 
Pregnancy and childbirth are triggers for SUI (Li et al., 2023; 
Bortolotti et al., 2000) 
Lifestyle factors 
• Unhealthy voiding behavior (Hu and Pierre, 2019) and low 
physical activity may contribute to UUI onset (Li et al., 2023) 
• Smoking cessation is a general public health measure and 
has been shown to be weakly associated with 
improving urgency, frequency and UI (Danforth et al., 2006; 
Harding et al., 2023) 
• Decrease in fluid intake may improve some symptoms in 
patients with SUI and idiopathic detrusor overactivity 
(Swithinbank et al., 2005) 
• Reduction of caffeine intake may reduce symptoms of 
frequency and urgency (Harding et al., 2023) 
• An association was seen between alcohol consumption and 
urinary incontinence in middle-aged and older women (Lee 
& Hirayama, 2012) 
UI prevalence 
and 
symptomatology 
Frequency of urine 
leakage 
To assess the severity of UI among female, we need 
measuring the “frequency” and “usual amount” of leakage 
ranged from “moderate” to “strong” (Avery et al., 2004) 
Perceived quantity 
of urine leakage 
Type of urine 
leakage 
It is focused on subtypes of urinary incontinence (SUI, UUI 
and MUI) (Abrams et al., 2003) 
Time of onset of 
urine leakage 
The mean age in which urine leakage begins seems to be 
lower for SUI compared to MUI and UUI (Thangarajah et al., 
2020) 

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UI quality of life, 
social impact  
General interference 
with daily life 
The measurement of UI should incorporate the impact that 
the condition may have on quality of life (Avery et al., 2004) 
Interference with 
specifical activities 
Specifically: 
• Physical Activity 
• Social Relationships 
• Travel 
• Emotional Health 
(Monticone et al., 2021; Shumaker et al., 1994) 
Interference with 
sexual life 
Some articles report that UI affects sexual aspects of the 
individual (Felsted & Supiano, 2019; Marques et al., 2015). 
According to other studies, sexual activity does not seem to 
be damaged by UI (Siracusano et al., 2003) 
Costs 
Work productivity 
UI imposes a high economic burden because of work 
productivity loss (Goren et al., 2014)  
Weekly costs of 
hygiene care 
products 
UI is associated with substantial routine care “costs” (Subak 
et al., 2006) 
Healthcare 
resource utilization: 
1. Specialist visits  
2. Treatments 
Women with SUI/MUI consume significantly higher medical 
resources and incur higher costs to payers, compared to 
women without SUI/MUI (Datar et al., 2022) 
 
 
9.1 Instruments 
Three instruments will be employed to collect data, as reported in Table 2. 
 
 
 

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Table 2 - Instruments employed in the study 
Instrument 
Data of interests 
UI Survey 
Women’s socio-demographic and clinical 
characteristics based on the variables reported in 
Table 1 
Italian version of the International Consultation of 
Incontinence Modular Questionnaire Urinary 
Incontinence Short Form (ICIQ UI-SF) (Tubaro et al., 
2006) 
Prevalence and symptomatology of UI 
(Bedretdinova et al., 2015) 
 
Italian version of the Incontinence Impact 
Questionnaire-7 (IIQ-7) (Monticone et al., 2020) 
Impact on life of urinary incontinence among 
women (Shumaker et al., 1994) 
 
 
A survey, written in Italian by the authors and tested on a sample of 13 women between 40 and 65 
years old, will collect socio-demographic, economic and clinical characteristics of all the female participants 
included in the study. The requested data will be based on the variables reported in Table 1. 
The Italian version of the International Consultation of Incontinence Modular Questionnaire Urinary 
Incontinence Short Form (ICIQ UI-SF) will be used to investigate UI symptoms in women (Avery et al., 2004; 
Tubaro et al., 2006).  
 
The Italian version of the Incontinence Impact Questionnaire-7 will be used to assess the impact of 
UI on women’s quality of life (Monticone et al., 2021; Shumaker et al., 1994). 
The materials necessary for data collection will be included in a paper module for patients and 
caregivers and online for staff (see attachment). Each subject included will fill in the module which will be 
transmitted to the Promoter with the appropriately anonymized data. Given the growing need for digital 
data management in clinical trials and in compliance with current regulatory requirements, researchers will 
independently set up the eCRF (electronic Case Report Form), via the RedCap platform. 
In each hospital center involved in the study, a nurse will be identified, as the contact person of the 
Center, who will be responsible for supervising the appropriate recording of data and compliance with this 
research protocol. 
9.1.1 UI Survey 
A survey, written in Italian by the authors, will collect women’s socio-demographic, economic and 
clinical characteristics, based on the variables reported in Table 1. The entire survey is attached in Appendix. 

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A total of 29 questions will attempt to acquire information about some of the previously defined variables: 
specifically, 23 questions will be related to socio-demographic and clinical predictors of UI (n. 1-23), one 
question will be about the onset of the UI symptomatology (n. 35), one question about sexuality (n. 36) and 
four questions will investigate the direct and indirect costs of UI (n. 37-40). The survey was tested as a pilot 
on a sample of 13 women aged between 40 and 65 years old and was assessed as suitable for the following 
aspects: understanding and clarity of the questions, absence of questions that put the participant in difficulty, 
completion time (which resulted maximum of 5 minutes).  
9.1.2 International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short Form 
(ICIQ UI-SF) 
The International Consultation of Incontinence Modular Questionnaire Urinary Incontinence Short 
Form (ICIQ UI-SF) is a questionnaire that allows the assessment of the prevalence, frequency, and perceived 
cause of UI and its impact on everyday life. It is an appropriate scale for estimating national prevalence in 
representative samples (Bedretdinova et al., 2015). 
ICIQ UI-SF was developed and validated in English for the first time by Avery and colleagues in 2004, 
and then Tubaro and colleagues made an Italian Validation in 2006. This last version will be used in the study.  
The questionnaire comprises four question items and the reference period for symptom assessment 
is the four weeks preceding the day that the questionnaire is administered. The total score for the ICIQ-SF is 
calculated as the sum of scores obtained from the frequency of urinary incontinence episodes (from 0 or 
‘never’, increasing by 1 unit up to 5 or ‘always’), perceived quantity of urine losses (0 or ‘no loss’, increasing 
by 2 units up to 6 or ‘a large amount’) and quality of life (from 0 or ‘no interference’ of urinary incontinence 
with life, increasing by 1 unit up to 10 or ‘maximum interference’). The theoretical range of total score values 
is therefore 0-21. A higher score indicates greater impairment from incontinence. The fourth question is an 
unscored self-diagnostic item about the type of urine leakage (Tubaro et al., 2006).  
The instrument has a GRADE A on the level of validation according to the International Consultation 
of Incontinence (ICI) grades of recommendation; this means that the questionnaire has good validity, 
reliability and responsiveness established with rigor in several data sets. Specifically, the internal consistency 
of the ICIQ-SF is satisfactory overall, with a Cronbach’s α of 0.896. Also the test-retest reliability is good; the 
Pearson r coefficient is almost equal to 1 for the total score and varies steadily at ≈ 0.9 for all items. Intraclass 
correlation coefficients for the total score and the quality of life item are, respectively, 0.93 and 0.96 (Tubaro 
et al., 2006). The entire questionnaire is attached in the Appendix (questions n. 24-27). 
 
9.1.3 Incontinence Impact Questionnaire-7 (IIQ-7) 
The Incontinence Impact Questionnaire-7 (IIQ-7) was developed in 1994 to assess the impact on life of urinary 
incontinence among women (Shumaker et al., 1994). 
IIQ-7 is a self-administered, seven-item questionnaire referring to the individual’s perceived impact 
of urinary incontinence on daily activities, relationships, and feelings. Each item has a four-point response 
scale, where individuals rate the extent to which urine leakage affects their daily functioning (0 = not at all; 

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1 = slightly; 2 = moderately; 3 = greatly). According to the original authors, this tool examines four domains: 
physical activity (items 1 and 2), travel (items 3 and 4), social activities (item 5) and emotional health (items 
6 and 7). The sum is averaged and the mean (from 0 to 3) is multiplied by 33 1/3 to obtain a score on a 0–
100 scale (Uebersax et al., 1995). A higher score indicates more severe symptoms and lower quality of life 
(Monticone et al., 2020). 
Overall, the Italian version of the Incontinence Impact Questionnaire-7 shows acceptable basic 
psychometric properties: time to complete the questionnaire is almost four minutes, Cronbach’s α is 0.88, 
item-scale correlations are all > 0.66, and item-rest correlation values (rs) range from 0.53 (item 1 “Household 
chores”) to 0.70 (item 4 “Travel > 30 min away from home”). Test–retest reliability is excellent (ICC 2.1 = 0.92 
with 95% confidence interval 0.88–0.94). The Standard Error of Measurement and Minimum Detectable 
Change95 are, respectively, 6.5 and 18.1 points (Monticone et al., 2021). The entire questionnaire is presented 
in the Appendix (questions n. 28-34).    
 
10. DATA MANAGEMENT AND QUALITY CONTROL 
 
The data collection process will be carried out by nurses and midwives of the four involved hospitals 
and Vita-Salute San Raffaele University, who will be specifically trained by the research group. The data of 
the survey and the questionnaires will be collected in the eCRF. Only researchers and authorized users will 
be able to view the dataset. It will present suitable privacy and anonymity protection requirements according 
to the provisions of European law (General Data Protection Regulation (GDPR), 2016; available at: 
https://gdpr-info.eu/). Jamovi 2.3.21 software will be used to conduct the data statistical analyses.  
 
11. NUMBER OF CASES 
The population sample cannot be decided accurately in advance. Population studies from numerous 
countries have reported that the prevalence of UI among all adult women ranged from approximately 5% to 
70% worldwide, with most studies reporting a prevalence of UI in the range of 25–45% (Miano et al., 2012; 
Milsom & Gyhagen, 2019). To date, limited epidemiologic research has been conducted in Italy on this 
matter. One of the most recent Italian studies was conducted in 2002 and prevalence of UI was found to be 
10.2% in a sample of 13365 women older than 40 years (Miano et al., 2012; Parazzini, Lavezzari & Arbitani, 
2002).  
To define an indicative sample size for our search, reference will be made to the sample considered 
by two prevalence studies conducted in some specifical Italian districts. The first one proposed telephonic 
interviews to the population of a big area composed by six cities, including a total of 2.767 women aged ≥ 40 
years old (Bortolotti et al., 2000). The second study investigated by questionnaire the prevalence and 
characteristics of UI in a female sample composed by 2.900 subjects aged between 18 and 49 years living in 
the urban area of Trieste (Siracusano et al., 2003).  
Our study will investigate UI prevalence in middle-aged women (40-65 years old) identified in four 
hospitals in Northern Italy. The competent Departments were asked for data on the average daily accesses 
of patients to the hospitals involved and the number of female personnel hired with an age range of 40-65 

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years. As regards the female personnel between 40 and 65 years old hired at San Raffaele Hospital and San 
Raffaele Turro Hospital, there are 1.842 employees. The sample will be determined based on the data we 
will receive from other hospitals. 
After this study, we could expand the protocol to include other centers to better evaluate the 
phenomenon and investigate the prevalence in a larger population.  
 
12. SUBJECT'S POTENTIAL RISKS AND BENEFITS 
No subject’s potential risks are associated with the study and study procedures.   
12.1 Bias risk 
The included population could present Recall Bias (Delgado-Rodríguez, 2004) during the survey 
filling, particularly with the ICIQ-UI SF, because it refers to the last four weeks before the filling. This study 
could present the Underreporting Bias (Delgado-Rodríguez, 2004) because the survey asks for behaviors that 
negatively affect the personal and social life. The researchers decided to use a bias risk assessment tool 
during the drafting of the protocol to ensure the study quality. This tool will also accompany the writing of 
the paper in the future. It consists of a modification and an upgrade of the existing tool developed initially by 
Leboeuf-Yde and Lauritsen (Leboeuf-Yde & Lauritsen, 1995; Hoy et al., 2012). The tool is based on the Grades 
of Recommendation, Assessment, Development and Evaluation (GRADE) and Cochrane approaches (Higgins 
& Green, 2008; Terracciano et al, 2010).  
The tool consists of 10 items addressing four domains of bias plus a summary risk of bias assessment: 
items 1 to 4 assess the external validity of the study (domains are selection and nonresponse bias), and items 
5 to 10 assess the internal validity (items 5 to 9 assess the domain of measurement bias, and item 10 assesses 
bias related to the analysis) (Hoy et al., 2012). Table 3 illustrates the items of the risk of bias tool.  
After completing the reporting of the manuscript (except for the risk of bias assessment), two blinded 
raters will give their opinion on the quality of the study. Response options for individual items (from 1 to 10) 
will be “low” or “high” risk of bias (if there will be insufficient information in the report to permit a judgment 
for a particular item, then the item will be deemed to be at high risk of bias). Response options for the 
summary assessment (item 11) will be “low”, “moderate”, or “high” risk of bias (Hoy et al., 2012). Overall 
interrater agreement will be calculated by considering each of the 10 items plus the summary assessment. 
 
Table 3 - The items of the risk of bias tool 
# 
Item 
1 
Was the study’s target population a close representation of the national population in relation to 
relevant variables? 
2 
Was the sampling frame a true or close representation of the target population? 

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3 
Was some form of random selection used to select the sample, or was a census undertaken? 
4 
Was the likelihood of nonresponse bias minimal? 
5 
Were data collected directly from the subjects (as opposed to a proxy)? 
6 
Was an acceptable case definition used in the study? 
7 
Was the study instrument that measured the parameter of interest shown to have validity and 
reliability? 
8 
Was the same mode of data collection used for all subjects? 
9 
Was the length of the shortest prevalence period for the parameter of interest appropriate? 
10 
Were the numerator(s) and denominator(s) for the parameter of interest appropriate? 
11 
Summary item on the overall risk of study bias 
 
13. STATISTICAL ANALYSES 
 
Descriptive and position analyses (mean, median, standard deviation, and interquartile range) will 
be conducted for the description of the quantitative variables. Categorical variables will be described with 
linear models. Any classification or stratification techniques (multivariate statistics) will be applied to identify 
participants' profiles. All the statistical analyses will be conducted using the statistical package for the social 
sciences, Jamovi 2.3.21 software.  
 
14. ETHICAL ASPECTS 
 
This study will be conducted in accordance with the present protocol, with the principles of good 
clinical practice, according to the ICH Good Clinical Practice standards and the requirements of the 
Guidelines, with the principles of the Declaration of Helsinki. The study protocol and all other necessary 
documents will be submitted to the Competent Authorities. Amendments and new versions of the protocol 
will be promptly shared with the competent Ethics Committee. The present study will be conducted in 
accordance with the protocol defined by the investigators involved. 
Before starting any study procedure, the study protocol and documents will be notified to the Clinical 
Trial Center and the Ethics Committee of the San Raffaele Hospital in Milan. 
 

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15. PARTICIPANT INFORMATION AND CONSENT 
 
All the participants will be invited to voluntarily contribute to the study. The purpose of the study 
and related procedures will be explained to them. The participants will also be allowed to clarify doubts or 
uncertainties by asking questions and receiving clear and satisfactory answers. Having read the study 
information, the participants will have the time to decide whether to proceed with signing the informed 
consent. Healthcare professionals and administrative workers will agree to a brief privacy policy and 
electronic release of informed consent (by email) before completing the survey and the questionnaires. For 
female patients and female caregivers’, a paper informed consent will be required to be signed. The decision 
not to participate in the survey will not affect future nursing care. All participants receive the same care and 
support from healthcare personnel. Prior to participation in the study, the subjects will receive a copy of the 
signed and dated written informed consent form.  
 
16. DATA QUALITY, DATABASE MANAGEMENT 
 
The research group will be responsible for data management, data control and quality assurance. 
The anonymous data will be collected in the eCRF: the data deriving from healthcare professionals and 
administrative workers will be directly registered in RedCap, while the paper data of patients and caregivers 
will be manually uploaded. 
The data collected will be recorded, processed, managed and archived in paper form and in an automated 
and computerised form for the sole purposes connected with research, in compliance with Legislative Decree 
30/06/2003 n°196 and subsequent authorizations and in compliance with the European regulation n. 679 of 
2016. The Principal Investigator will be responsible for data management. 
In each hospital center involved in the study, a nurse will be identified as the contact person of the Center, 
who will be responsible for supervising the appropriate recording of data and compliance with this research 
protocol.  
All data contained in the database specifically set up for the study cannot be attributable to the individual 
patient: the data are collected anonymously. The patient's personal data are not of interest to the 
Experimentation in question.  
 
16.1 Data confidentiality and privacy 
The privacy of the recruited subjects will be completely guaranteed, and the data will be treated 
confidentially in the terms prescribed by Italian law in the Legislative Decree 30 June 2003, n. 196, "Code 
regarding the protection of personal data" (Official Gazette n. 174 of 29 July 2003 – Ordinary Supplement n. 
123) and in compliance with the European General Data Protection Regulation n.679 of 2016. The data 
collected during the study will be kept anonymous and processed for scientific purposes only. They will never 
be published as individual data but will serve exclusively, in an aggregated way with those of all the other 

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participants in the study, to produce descriptive analysis results. The investigators ensure that the 
confidentiality of the participants will be maintained and only an identification number in the register will 
identify them. All documents will be kept securely and accessible only by the investigators or other authorised 
personnel. The study will comply with the Italian laws on protecting personal data and the guidelines 
stipulated on July 24, 2008. 
16.2 Data ownership 
     The ownership of the data relating to the study, its execution and its results belong to the 
Promoter (DL 17/12/2004). The Coordinating Center will be responsible for data management and storage in 
compliance with the current regulations (DL 196/2003: “Data Protection Code personal data, June 30, 2003"). 
The study is promoted by the IRCCS San Raffaele Hospital (Milan), which will also take care of the scientific 
and operational coordination and which will be responsible for the ownership of the data deriving from the 
research.  
 
17. DATA PUBLICATION 
 
The research will be made known to the population and to all interested people through 
communications at conferences, congresses, symposiums, dissemination articles and articles in national and 
international scientific journals. The research group must authorise and coordinate any studies derived from 
subgroup analyses. The research group will prepare the study's final report, which will be presented in a 
meeting. The research group will define the authorship of the works that will be produced in relation to the 
involvement and work done by the individual. In all the works that will be produced, the promoter of the 
study must be reported and mentioned in the acknowledgements section. 
All publications and/or communications related to the study will be approved in advance by the 
research group. The transmission or dissemination of global data, through scientific publications and / or 
presentation in congresses, conferences and seminars, will take place exclusively following the consent of 
the Promoter Center and the Hospital Centers included in the study after statistical processing of the same 
and in any case in aggregate and anonymous form. 
 
18. CONSERVATION OF STUDY DOCUMENTS 
 
All information relating to the study participants, the documentation relating to the submission and 
approval by the EC and the regulatory documentation will be kept by the Principal Investigator in the archive 
of the IRCCS San Raffaele Hospital (Milan). 
 
 

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19. FINANCIAL ARRANGEMENTS 
 
The study is non-profit. Given the observational nature of the study, insurance coverage is not 
provided as it is unnecessary.  
 
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